ANDROMEDA study investigated the first and only subcutaneous anti-CD38 monoclonal antibody in treatment of rare multi-system disease with a high unmet medical need for which there are currently no approved therapies

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the first randomised Phase 3 study investigating the subcutaneous (SC) formulation of DARZALEX (daratumumab) in the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare and potentially fatal disease.1,2 The data demonstrated daratumumab SC in combination with cyclophosphamide, bortezomib, and dexamethasone (D-CyBorD) resulted in a significantly higher haematologic complete response rate (CR), 53 percent vs. 18 percent (P<0.0001), compared to CyBorD.3 Additionally, treatment with D-CyBorD delayed the time to major organ deterioration (MOD), haematologic progression or death (MOD-PFS), and enhanced event-free survival (MOD-EFS) based on MOD-PFS criteria with the time to initiation of next therapy.3 The combination showed a safety profile consistent with daratumumab SC or CyBorD alone.3

The results are being highlighted during a press briefing at the 25th European Hematology Association (EHA) Annual Congress today and will be presented during the late-breaking oral session on Sunday, June 14 at 03:00 p.m. CEST (Abstract LB2604).3

AL amyloidosis is a rare and potentially fatal multi-system disorder that occurs when the bone marrow produces abnormal pieces of antibodies called light chains, which clump together to form an amyloid.1 This amyloid is deposited in tissues and vital organs and interferes with normal organ function.1,2 As the disease progresses, many patients experience gradual deterioration to multiple organs, including the heart, kidneys, liver, nervous system and digestive tract.2 Prognosis is dependent on multiple factors including the pattern and number of organs involved and the treatment regimen.4,5 Patients with AL amyloidosis have a poor prognosis with an estimated median survival ranging from six months to three years depending on the patient population and data used.4 There are currently no therapy options approved by regulatory bodies such as the European Medicines Agency (EMA) or U.S. Food and Drug Administration (FDA) to treat this devastating disease.6,7

"Due to widely varying symptoms of AL amyloidosis, which can be mistaken for more common conditions, patients are often faced with a delayed diagnosis of several years. These delays to diagnosis and treatment impact on emotional wellbeing, and lead to poorer outcomes for patients," said Giovanni Palladini, M.D., Ph.D., acting director of the Amyloidosis Research and Treatment Center at the University Hospital San Matteo in Pavia, Italy and study investigator*. "Current therapies focus on slowing the production of amyloid protein and managing symptoms, but there is no approved treatment for AL amyloidosis. The results of the ANDROMEDA study have demonstrated the potential of daratumumab for newly diagnosed patients with AL amyloidosis, which could fulfil a great unmet need and alleviate the burden of organ damage for these patients."

Results from the ANDROMEDA study showed that the primary endpoint, haematologic CR rate, was 53 percent for D-CyBorD and 18 percent for CyBorD (Odds Ratio=5.1; 95 percent confidence interval [CI], 3.2-8.2; P<0.0001).3 In addition, patients receiving D-CyBorD achieved higher rates of overall haematologic response (92 percent vs. 77 percent) and very good partial response or better (VGPR; 79 percent vs. 49 percent) than patients receiving CyBorD.3 Among the 195 patients who responded to treatment in the D-CyBorD arm, median time to VGPR/CR was 17/60 days compared to the 193 patients in the CyBorD arm whose median time to VGPR was 25/85 days.3

The six-month organ response rate nearly doubled for patients treated with D-CyBorD versus CyBorD, for both cardiac (42 percent vs. 22 percent; P=0.0029) and renal (54 percent vs. 27 percent; P<0.0001) responses.3 Additionally, MOD-PFS (Hazard Ratio=0.58; 95 percent CI, 0.36-0.93, P=0.0224) and MOD-EFS (Hazard Ratio=0.40; 95 percent CI, 0.28-0.57, P<0.0001) favoured the D-CyBorD arm, demonstrating substantially delayed major organ deterioration, haematologic progression, or death, as well as improved event-free survival.3 In addition, the D-CyBorD arm, which is delivered subcutaneously, helps to limit intravenous fluid overload, an important treatment factor in the setting of cardiac compromised patients.3

"Through the daratumumab development programme, Janssen has deep expertise in diseases where CD38 is highly expressed. Daratumumabs mode-of-action gives us an opportunity to treat the underlying cause of AL amyloidosis and potentially bring a new therapy option to patients living with this rare disease," said Patrick Laroche, M.D., Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag. "Since launch daratumumab has treated over 130,000 patients worldwide and has become the foundation of multiple myeloma treatment, and we will continue to investigate its potential in diseases in which CD38 is expressed."

The most common Grade 3/4 treatment emergent adverse events occurring in more than 5 percent of patients for the D-CyBorD arm compared to the CyBorD arm, included lymphopenia (13 percent vs. 10 percent), pneumonia (8 percent vs. 4 percent), diarrhoea (6 percent vs. 4 percent), cardiac failure (6 percent vs. 5 percent), neutropenia (5 percent vs. 3 percent), syncope (5 percent vs. 6 percent) and peripheral oedema (3 percent vs. 6 percent).3 The study showed daratumumab SC had a low rate of administration-related reactions (ARR).3 Systemic ARRs in the D-CyBorD arm occurred in 14 patients (7 percent), all were Grade 1-2 and most occurred during the initial administration. A total of 56 deaths occurred (D-CyBorD, n=27; CyBorD, n=29).3

#ENDS#

In Europe, daratumumab is indicated:8

About the ANDROMEDA Study3,9

ANDROMEDA (NCT03201965) is an ongoing Phase 3, randomised, open-label study investigating the safety and efficacy of daratumumab SC in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD), compared to CyBorD alone, in the treatment of patients with newly diagnosed light chain (AL) amyloidosis.3,9 The study included 388 patients with newly diagnosed AL amyloidosis with measurable haematologic disease and one or more organs affected. The primary endpoint was overall complete haematologic response rate (intent-to-treat / ITT). Secondary endpoints included major organ deterioration, progression-free survival, event free survival, organ response rate, overall survival, and time to haematologic response, among others.3,9

About AL Amyloidosis

Light chain (AL) amyloidosis is a rare and potentially fatal haematologic disorder that can affect the function of multiple organs.1,2 The disease occurs when bone marrow produces abnormal pieces of antibodies called light chains, which clump together to form a substance called amyloid. These clumps of amyloid are deposited in tissues and vital organs and interfere with normal organ function, eventually causing organ deterioration.1,2 It is the most common type of amyloidosis. AL amyloidosis frequently affects the heart, kidneys, digestive tract, liver and nervous system and is potentially fatal if left untreated.1,2 Diagnosis is often delayed and prognosis is poor due to advanced, multi-organ, particularly cardiac, involvement.1,2 Approximately 30,000 to 45,000 patients in the United States and the European Union have AL amyloidosis.10

About daratumumab and daratumumab SC

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma (MM) cells, regardless of disease stage.8,11 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.11 A subset of myeloid derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) are decreased by daratumumab-mediated cell lysis.11

In Europe, daratumumab has been approved in five indications, three of which are in the frontline setting, including newly diagnosed MM patients who are transplant eligible and ineligible.8 In June 2020, daratumumab SC (daratumumab and hyaluronidase human-fihj) was approved the European Commission as the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma.12 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology.12

Since launch, it is estimated that 130,000 patients have been treated with daratumumab worldwide.13

Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in MM, such as in frontline and relapsed settings.14,15,16,17,18,19,20,21 Additional studies are ongoing or planned to assess daratumumab SCs potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma and in AL amyloidosis.22,23 For more information, please see https://www.clinicaltrials.gov/.

For further information on daratumumab, please see the Summary of Product Characteristics at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex.

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.24

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, were creating a future where disease is a thing of the past. Were the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at http://www.janssen.com/emea. Follow us at http://www.twitter.com/janssenEMEA for our latest news. Janssen-Cilag, Janssen Pharmaceutica NV, and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the benefits of daratumumab for the treatment of patients with multiple myeloma. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the companys most recently filed Quarterly Report on Form 10-Q, and the companys subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

ENHANZE is a registered trademark of Halozyme.* Professor Giovanni Palladini has an ongoing contractual relationship with Janssen Pharmaceutica N.V.

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References

1 Desport E, Bridoux F, Sirac C, Delbes S, Bender S, Fernandez B, Quellard N, Lacombe C, Goujon JM, Lavergne D, Abraham J. Al amyloidosis. Orphanet journal of rare diseases. 2012 Dec;7(1):54.2 Merlini G, Comenzo RL, Seldin DC, Wechalekar A, Gertz MA. Immunoglobulin light chain amyloidosis. Expert review of hematology. 2014 Feb 1;7(1):143-56.3 Kastritis, E. et al. Subcutaneous Daratumumab + Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis: Primary Results from the Phase 3 ANDROMEDA Study [LBA]. To be presented at European Hematology Association 2020 Annual Congress.4 McCausland KL, White MK, Guthrie SD, Quock T, Finkel M, Lousada I, Bayliss MS. Light chain (AL) amyloidosis: the journey to diagnosis. The Patient-Patient-Centered Outcomes Research. 2018 Apr 1;11(2):207-16.5 Quock TP, Yan T, Chang E, Guthrie S, Broder MS. Epidemiology of AL amyloidosis: a real-world study using US claims data. Blood advances. 2018 May 22;2(10):1046-53.6 European Medicines Agency. EU/3/19/2222 AL Amyloidosis. Available at: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3192222 Last accessed: June 2020.7 Leng S, Bhutani D, Lentzsch S. Amyloid Therapy and Targets. Clinical Lymphoma, Myeloma and Leukemia. 2019 Sep 1;19:S49-52.8 European Medicines Agency. DARZALEX summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf Last accessed: June 2020.9 ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis. NCT03201965. Available at: https://clinicaltrials.gov/ct2/show/NCT03201965 Last accessed: June 2020.10 Lousada I, Comenzo RL, Landau H, Guthrie S, Merlini G. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in therapy. 2015 Oct 1;32(10):920-8.11 Sanchez L, Wang Y, Siegel DS, Wang ML. Daratumumab: a first-in-class CD38 monoclonal antibody for the treatment of multiple myeloma. J Hematol Oncol. 2016;9:51.12 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX(daratumumab) Subcutaneous Formulation for all Currently Approved Daratumumab Intravenous Formulation Indications. Press Release June 04, 2020. Available at: https://www.janssen.com/emea/sites/www_janssen_com_emea/files/european_commission_grants_marketing_authorisation_for_darzalexrvdaratumumab_subcutaneous_formulation_for_all_currently_approved_daratumumab_intravenous_formulation_indications.pdf Last accessed: June 2020.13 [Data on file]. DARZALEX: New Patient Starts Launch to Date. RF-12414814 ClinicalTrials.gov. A study to evaluate daratumumab in transplant eligible participants with previously untreated multiple myeloma (Cassiopeia). NCT02541383. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383 Last accessed: June 202015ClinicalTrials.gov. A study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma. NCT02076009. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009 Last accessed: June 2020.16 ClinicalTrials.gov. Addition of daratumumab to combination of bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma. NCT02136134. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134 Last accessed: June 2020.17 ClinicalTrials.gov. A study of combination of daratumumab and Velcade (bortezomib) melphalan-prednisone (DVMP) compared to Velcade melphalan-prednisone (VMP) in participants with previously untreated multiple myeloma. NCT02195479. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479 Last accessed: June 2020.18ClinicalTrials.gov. Study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in participants with previously untreated multiple myeloma. NCT02252172. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172 Last accessed: June 2020.19 ClinicalTrials.gov. A study of Velcade (bortezomib) melphalan-prednisone (VMP) compared to daratumumab in combination with VMP (D-VMP), in participants with previously untreated multiple myeloma who are ineligible for high-dose therapy (Asia Pacific region). NCT03217812. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812 Last accessed: June 2020.20ClinicalTrials.gov. Comparison of pomalidomide and dexamethasone with or without daratumumab in subjects with relapsed or refractory multiple myeloma previously treated with lenalidomide and a proteasome inhibitor daratumumab/pomalidomide/dexamethasone vs pomalidomide/dexamethasone (EMN14). NCT03180736. Available at: https://clinicaltrials.gov/ct2/show/NCT03180736 Last accessed: June 2020.21ClinicalTrials.gov. Study of carfilzomib, daratumumab and dexamethasone for patients with relapsed and/or refractory multiple myeloma (CANDOR). NCT03158688. Available at: https://clinicaltrials.gov/ct2/show/NCT03158688 Last accessed: June 2020.22 ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma. NCT03301220. Available at: https://clinicaltrials.gov/ct2/show/NCT03301220 Last accessed: June 2020.23ClinicalTrials.gov. A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis. NCT04131309. Available at: https://clinicaltrials.gov/ct2/show/NCT04131309 Last accessed: June 2020.24 Johnson & Johnson. Janssen Biotech announces global license and development agreement for investigational anti-cancer agent daratumumab. Press release August 30, 2012. Available at: https://www.jnj.com/media-center/press-releases/janssen-biotech-announces-global-license-and-development-agreement-for-investigational-anti-cancer-agent-daratumumab Last accessed: June 2020.

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Subcutaneous Formulation of DARZALEX(Daratumumab) Combination Resulted in Deep and Rapid Haematologic Responses and Improved Clinical Outcomes in the...

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89% of evaluable patients (17/19) with transfusion-dependent -thalassemia who do not have a 0/0 genotype achieved transfusion independence with 11.9 g/dL median weighted average total hemoglobin (Hb) level in HGB-207

Data from exploratory analyses of HGB-207 show improved markers of blood cell production and bone marrow function in patients who achieved transfusion independence

85% of patients (11/13) with a 0/0 genotype or IVS-I-110 mutation in HGB-212 have been transfusion-free for at least 7 months

CAMBRIDGE, Mass. bluebird bio, Inc. (Nasdaq: BLUE) today announced that new data from ongoing Phase 3 studies of betibeglogene autotemcel (beti-cel; formerly LentiGlobin for -thalassemia gene therapy) show pediatric, adolescent and adult patients with a range of genotypes of transfusion-dependent -thalassemia (TDT) achieve and maintain transfusion independence with hemoglobin (Hb) levels that are near-normal (10.5 g/dL). These data are being presented at the Virtual Edition of the 25th European Hematology Association (EHA25) Annual Congress.

With more than a decade of clinical experience evaluating gene therapy in patients with transfusion dependent -thalassemia across a wide range of ages and genotypes, we have built the most comprehensive understanding of treatment outcomes in the field, said David Davidson, M.D., chief medical officer, bluebird bio. Seeing patients achieve transfusion independence and maintain that positive clinical benefit over time with robust hemoglobin levels reflects our initial vision of the potential of beti-cel. The accumulating long-term data demonstrating improvements in bone marrow histology, iron balance and red cell biology support the potential of beti-cel to correct the underlying pathophysiology of transfusion-dependent -thalassemia.

A total of 60 pediatric, adolescent and adult patients across genotypes of TDT have been treated with beti-cel in the Phase 1/2 Northstar (HGB-204) and HGB-205 studies, and the Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies as of March 3, 2020. In studies of beti-cel, transfusion independence is defined as no longer needing red blood cell transfusions for at least 12 months while maintaining a weighted average Hb of at least 9 g/dL.

TDT is a severe genetic disease caused by mutations in the -globin gene that results in significantly reduced or absent adult hemoglobin (HbA). In order to survive, people with TDT maintain Hb levels through lifelong, chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload.

Patients with transfusion-dependent -thalassemia do not make enough healthy red blood cells and cannot live without chronic transfusions; for patients that means a lifetime of necessary visits to a hospital or clinic and reliance on an often unreliable blood supply, which compounds the challenges of managing this disease, said presenting study author Professor John B. Porter, MA, M.D., FRCP, FRCPath, University College London Hospital, London, UK. These results showing patients free from transfusions and maintaining near-normal hemoglobin levels after treatment with beti-cel is a positive outcome for people living with transfusion-dependent -thalassemia. In addition, we now have more data that provide further evidence that most of these patients have a measurable improvement in markers of healthy red blood cell production.

Beti-cel is a one-time gene therapy designed to address the underlying genetic cause of TDT by adding functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). This means there is no need for donor HSCs from another person, as is required for allogeneic HSC transplantation (allo-HSCT). Once a patient has the A-T87Q-globin gene, they have the potential to produce HbAT87Q, which is gene therapy-derived Hb, at levels that eliminate or significantly reduce the need for transfusions.

Northstar-2 (HGB-207) Efficacy

As of March 3, 2020, all 23 patients in HGB-207 were treated and have been followed for a median of 19.4 months. These patients ranged in age from four to 34 years, including eight pediatric (<12 years of age) and 15 adolescent/adult (>12 years of age) patients. Only 19 patients were evaluable for transfusion independence; four additional patients do not yet have sufficient follow-up to be assessed for transfusion independence.

Eighty-nine percent of evaluable patients (17/19) achieved transfusion independence, with median weighted average total Hb levels of 11.9 g/dL (min-max: 9.4 12.9 g/dL) over a median of 19.4 months of follow-up to date (min-max: 12.3 31.4 months). These 17 patients previously required a median of 17.5 transfusions per year (min-max: 11.5 37 transfusions per year).

Improved iron levels, as measured by serum ferritin and hepcidin levels (proteins involved in iron storage and homeostasis), were observed and trends toward improved iron management were seen. Over half of patients stopped chelation therapy, which is needed to reduce excess iron caused by chronic blood transfusions. Seven out of 23 patients began using phlebotomy for iron reduction.

Analysis of Healthy Red Blood Cell Production

In exploratory analyses, biomarkers of ineffective erythropoiesis (red blood cell production) were evaluated in patients who achieved transfusion independence in HGB-207.

The myeloid to erythroid (M:E) ratio in bone marrow from patients who achieved transfusion independence increased from a median of 1:3 (n=17) at baseline to 1:1.2 (n=16) at Month 12. Improvement of the M:E ratio, the ratio of white blood cell and red blood cell precursors in the bone marrow, suggests an improvement in mature red blood cell production. Images illustrating the bone marrow cellularity at baseline, Month 12 and Month 24 are available in the EHA25 presentation (abstract #S296): Improvement in erythropoiesis in patients with transfusion-dependent -thalassemia following treatment with betibeglogene autotemcel (LentiGlobin for -thalassemia) in the Phase 3 HGB-207 study.

Additionally, biomarkers of erythropoiesis continue to demonstrate a trend toward normalization in patients who achieved transfusion independence, including improved levels over time of erythropoietin, a hormone involved in red blood cell production; reticulocytes, immature red blood cells; and soluble transferrin receptor, a protein measured to help evaluate iron status. The continued normalization of red blood cell production over time among some patients who achieved transfusion independence supports the disease-modifying potential of beti-cel in patients with TDT.

Northstar-3 (HGB-212) Efficacy

As of March 3, 2020, 15 patients (genotypes: 9 0/0, 3 0/ +IVS1-110, 3 homozygous IVS-1-110 mutation) were treated and had a median follow-up of 14.4 months (min-max: 1.124.0 months). Median age at enrollment was 15 (min-max: 4 33 years).

Six of eight evaluable patients achieved transfusion independence, with median weighted average total Hb levels of 11.5 g/dL (min-max: 9.5 13.5 g/dL), and continued to maintain transfusion independence for a median duration of 13.6 months (min-max: 12.2 21.2 months) as of the data cutoff.

Eighty-five percent of patients (11/13) with at least seven months of follow-up had not received a transfusion in more than seven months at time of data cutoff. These 11 patients previously required a median of 18.5 transfusions per year (min-max: 11.0 39.5 transfusions per year). In these patients, gene therapy-derived HbAT87Q supported total Hb levels ranging from 8.814.0 g/dL at last visit.

Betibeglogene autotemcel Safety

Non-serious adverse events (AEs) observed during the HGB-207 and HGB-212 trials that were considered related or possibly related to beti-cel were tachycardia, abdominal pain, pain in extremities, leukopenia, neutropenia and thrombocytopenia. One serious event of thrombocytopenia was considered possibly related to beti-cel.

In HGB-207, serious events post-infusion in two patients included three events of veno-occlusive liver disease and two events of thrombocytopenia. In HGB-212, serious events post-infusion in two patients included two events of pyrexia.

Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease.

In both Phase 3 studies, there have been no deaths, no graft failure, no cases of vector-mediated replication competent lentivirus or clonal dominance, no leukemia and no lymphoma.

The presentations are now available on demand on the EHA25 website:

About betibeglogene autotemcel

The European Commission granted conditional marketing authorization (CMA) for betibeglogene autotemcel (beti-cel; formerly LentiGlobin gene therapy for -thalassemia), marketed as ZYNTEGLO gene therapy, for patients 12 years and older with transfusion-dependent -thalassemia (TDT) who do not have a 0/0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate, but a human leukocyte antigen (HLA)-matched related HSC donor is not available. On April 28, 2020, the European Medicines Agency (EMA) renewed the CMA for ZYNTEGLO, supported by data from 32 patients treated with ZYNTEGLO, including three patients with up to five years of follow-up.

TDT is a severe genetic disease caused by mutations in the -globin gene that result in reduced or significantly reduced hemoglobin (Hb). In order to survive, people with TDT maintain Hb levels through lifelong chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload.

Beti-cel adds functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once a patient has the A-T87Q-globin gene, they have the potential to produce HbAT87Q, which is gene therapy-derived hemoglobin, at levels that may eliminate or significantly reduce the need for transfusions.

Non-serious adverse events (AEs) observed during clinical studies that were attributed to beti-cel included abdominal pain, thrombocytopenia, leukopenia, neutropenia, hot flush, dyspnea, pain in extremity and non-cardiac chest pain. Two serious adverse events (SAE) of thrombocytopenia was considered possibly related to beti-cel.

Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease.

The CMA for beti-cel is valid in the 27 member states of the EU as well as UK, Iceland, Liechtenstein and Norway. For details, please see the Summary of Product Characteristics (SmPC).

The U.S. Food and Drug Administration (FDA) granted beti-cel orphan drug designation and Breakthrough Therapy designation for the treatment of transfusion-dependent -thalassemia. Beti-cel is not approved in the U.S.

Beti-cel continues to be evaluated in the ongoing Phase 3 Northstar-2 and Northstar-3 studies. For more information about the ongoing clinical studies, visit http://www.northstarclinicalstudies.com or clinicaltrials.gov and use identifier NCT02906202 for Northstar-2 (HGB-207) and NCT03207009 for Northstar-3 (HGB-212).

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of betibeglogene autotemcel or LentiGlobin for SCD. For more information visit: https://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

ZYNTEGLO, LentiGlobin, and bluebird bio are trademarks of bluebird bio, Inc.

bluebird bio Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the COVID-19 pandemic and resulting impact on our operations and healthcare systems will affect the execution of our development plans or the conduct of our clinical studies; the risk that the efficacy and safety results observed in the patients treated in our prior and ongoing clinical trials of beti-cel may not persist; and the risk that the efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated with additional patients in our ongoing or planned clinical trials or in the commercial context; the risk that the FDA will require additional information regarding beti-cel, resulting in a delay to our anticipated timelines for regulatory submissions, including submission of our BLA. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

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Elizabeth Pingpank, 617-914-8736 epingpank@bluebirdbio.com

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Majority of Evaluable Patients Across Genotypes Achieve Transfusion Independence and Maintain It with Near-Normal Hemoglobin Levels in Phase 3 Studies...

Recommendation and review posted by Bethany Smith

LOS ANGELES, United States: QY Research has recently published a report, titled COVID-19 Impact on Global Progenitor Cell Product, Market Insights and Forecast to 2026.The market research report is a brilliant, and much-needed resource for companies, stakeholders, and investors interested in the global COVID-19 Impact on Progenitor Cell Product market. It informs readers about key trends and opportunities in the global COVID-19 Impact on Progenitor Cell Product market along with critical market dynamics expected to impact the global market growth. It offers a range of market analysis studies, including production and consumption, sales, industry value chain, competitive landscape, regional growth, and price. On the whole, it comes out as an intelligent resource that companies can use to gain a competitive advantage in the global COVID-19 Impact on Progenitor Cell Product market.

Key companies operating in the global COVID-19 Impact on Progenitor Cell Product market include , NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI Progenitor Cell Product

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

https://www.qyresearch.com/sample-form/form/1823823/covid-19-impact-on-global-progenitor-cell-product-market

Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global COVID-19 Impact on Progenitor Cell Product market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Global COVID-19 Impact on Progenitor Cell Product Market Segment By Type:

, Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others Progenitor Cell Product

Global COVID-19 Impact on Progenitor Cell Product Market Segment By Application:

, Medical care, Hospital, Laboratory

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global COVID-19 Impact on Progenitor Cell Product market.

Key companies operating in the global COVID-19 Impact on Progenitor Cell Product market include , NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI Progenitor Cell Product

Key questions answered in the report:

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TOC

1 Study Coverage1.1 Progenitor Cell Product Product Introduction1.2 Market Segments1.3 Key Progenitor Cell Product Manufacturers Covered: Ranking by Revenue1.4 Market by Type1.4.1 Global Progenitor Cell Product Market Size Growth Rate by Type1.4.2 Pancreatic progenitor cells1.4.3 Cardiac Progenitor Cells1.4.4 Intermediate progenitor cells1.4.5 Neural progenitor cells (NPCs)1.4.6 Endothelial progenitor cells (EPC)1.4.7 Others1.5 Market by Application1.5.1 Global Progenitor Cell Product Market Size Growth Rate by Application1.5.2 Medical care1.5.3 Hospital1.5.4 Laboratory1.6 Coronavirus Disease 2019 (Covid-19): Progenitor Cell Product Industry Impact1.6.1 How the Covid-19 is Affecting the Progenitor Cell Product Industry 1.6.1.1 Progenitor Cell Product Business Impact Assessment Covid-19 1.6.1.2 Supply Chain Challenges 1.6.1.3 COVID-19s Impact On Crude Oil and Refined Products1.6.2 Market Trends and Progenitor Cell Product Potential Opportunities in the COVID-19 Landscape1.6.3 Measures / Proposal against Covid-19 1.6.3.1 Government Measures to Combat Covid-19 Impact 1.6.3.2 Proposal for Progenitor Cell Product Players to Combat Covid-19 Impact1.7 Study Objectives1.8 Years Considered 2 Executive Summary2.1 Global Progenitor Cell Product Market Size Estimates and Forecasts2.1.1 Global Progenitor Cell Product Revenue 2015-20262.1.2 Global Progenitor Cell Product Sales 2015-20262.2 Progenitor Cell Product Market Size by Region: 2020 Versus 20262.2.1 Global Progenitor Cell Product Retrospective Market Scenario in Sales by Region: 2015-20202.2.2 Global Progenitor Cell Product Retrospective Market Scenario in Revenue by Region: 2015-2020 3 Global Progenitor Cell Product Competitor Landscape by Players3.1 Progenitor Cell Product Sales by Manufacturers3.1.1 Progenitor Cell Product Sales by Manufacturers (2015-2020)3.1.2 Progenitor Cell Product Sales Market Share by Manufacturers (2015-2020)3.2 Progenitor Cell Product Revenue by Manufacturers3.2.1 Progenitor Cell Product Revenue by Manufacturers (2015-2020)3.2.2 Progenitor Cell Product Revenue Share by Manufacturers (2015-2020)3.2.3 Global Progenitor Cell Product Market Concentration Ratio (CR5 and HHI) (2015-2020)3.2.4 Global Top 10 and Top 5 Companies by Progenitor Cell Product Revenue in 20193.2.5 Global Progenitor Cell Product Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.3 Progenitor Cell Product Price by Manufacturers3.4 Progenitor Cell Product Manufacturing Base Distribution, Product Types3.4.1 Progenitor Cell Product Manufacturers Manufacturing Base Distribution, Headquarters3.4.2 Manufacturers Progenitor Cell Product Product Type3.4.3 Date of International Manufacturers Enter into Progenitor Cell Product Market3.5 Manufacturers Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026)4.1 Global Progenitor Cell Product Market Size by Type (2015-2020)4.1.1 Global Progenitor Cell Product Sales by Type (2015-2020)4.1.2 Global Progenitor Cell Product Revenue by Type (2015-2020)4.1.3 Progenitor Cell Product Average Selling Price (ASP) by Type (2015-2026)4.2 Global Progenitor Cell Product Market Size Forecast by Type (2021-2026)4.2.1 Global Progenitor Cell Product Sales Forecast by Type (2021-2026)4.2.2 Global Progenitor Cell Product Revenue Forecast by Type (2021-2026)4.2.3 Progenitor Cell Product Average Selling Price (ASP) Forecast by Type (2021-2026)4.3 Global Progenitor Cell Product Market Share by Price Tier (2015-2020): Low-End, Mid-Range and High-End 5 Breakdown Data by Application (2015-2026)5.1 Global Progenitor Cell Product Market Size by Application (2015-2020)5.1.1 Global Progenitor Cell Product Sales by Application (2015-2020)5.1.2 Global Progenitor Cell Product Revenue by Application (2015-2020)5.1.3 Progenitor Cell Product Price by Application (2015-2020)5.2 Progenitor Cell Product Market Size Forecast by Application (2021-2026)5.2.1 Global Progenitor Cell Product Sales Forecast by Application (2021-2026)5.2.2 Global Progenitor Cell Product Revenue Forecast by Application (2021-2026)5.2.3 Global Progenitor Cell Product Price Forecast by Application (2021-2026) 6 North America6.1 North America Progenitor Cell Product by Country6.1.1 North America Progenitor Cell Product Sales by Country6.1.2 North America Progenitor Cell Product Revenue by Country6.1.3 U.S.6.1.4 Canada6.2 North America Progenitor Cell Product Market Facts & Figures by Type6.3 North America Progenitor Cell Product Market Facts & Figures by Application 7 Europe7.1 Europe Progenitor Cell Product by Country7.1.1 Europe Progenitor Cell Product Sales by Country7.1.2 Europe Progenitor Cell Product Revenue by Country7.1.3 Germany7.1.4 France7.1.5 U.K.7.1.6 Italy7.1.7 Russia7.2 Europe Progenitor Cell Product Market Facts & Figures by Type7.3 Europe Progenitor Cell Product Market Facts & Figures by Application 8 Asia Pacific8.1 Asia Pacific Progenitor Cell Product by Region8.1.1 Asia Pacific Progenitor Cell Product Sales by Region8.1.2 Asia Pacific Progenitor Cell Product Revenue by Region8.1.3 China8.1.4 Japan8.1.5 South Korea8.1.6 India8.1.7 Australia8.1.8 Taiwan8.1.9 Indonesia8.1.10 Thailand8.1.11 Malaysia8.1.12 Philippines8.1.13 Vietnam8.2 Asia Pacific Progenitor Cell Product Market Facts & Figures by Type8.3 Asia Pacific Progenitor Cell Product Market Facts & Figures by Application 9 Latin America9.1 Latin America Progenitor Cell Product by Country9.1.1 Latin America Progenitor Cell Product Sales by Country9.1.2 Latin America Progenitor Cell Product Revenue by Country9.1.3 Mexico9.1.4 Brazil9.1.5 Argentina9.2 Central & South America Progenitor Cell Product Market Facts & Figures by Type9.3 Central & South America Progenitor Cell Product Market Facts & Figures by Application 10 Middle East and Africa10.1 Middle East and Africa Progenitor Cell Product by Country10.1.1 Middle East and Africa Progenitor Cell Product Sales by Country10.1.2 Middle East and Africa Progenitor Cell Product Revenue by Country10.1.3 Turkey10.1.4 Saudi Arabia10.1.5 U.A.E10.2 Middle East and Africa Progenitor Cell Product Market Facts & Figures by Type10.3 Middle East and Africa Progenitor Cell Product Market Facts & Figures by Application 11 Company Profiles11.1 NeuroNova AB11.1.1 NeuroNova AB Corporation Information11.1.2 NeuroNova AB Description, Business Overview and Total Revenue11.1.3 NeuroNova AB Sales, Revenue and Gross Margin (2015-2020)11.1.4 NeuroNova AB Progenitor Cell Product Products Offered11.1.5 NeuroNova AB Recent Development11.2 StemCells11.2.1 StemCells Corporation Information11.2.2 StemCells Description, Business Overview and Total Revenue11.2.3 StemCells Sales, Revenue and Gross Margin (2015-2020)11.2.4 StemCells Progenitor Cell Product Products Offered11.2.5 StemCells Recent Development11.3 ReNeuron Limited11.3.1 ReNeuron Limited Corporation Information11.3.2 ReNeuron Limited Description, Business Overview and Total Revenue11.3.3 ReNeuron Limited Sales, Revenue and Gross Margin (2015-2020)11.3.4 ReNeuron Limited Progenitor Cell Product Products Offered11.3.5 ReNeuron Limited Recent Development11.4 Asterias Biotherapeutics11.4.1 Asterias Biotherapeutics Corporation Information11.4.2 Asterias Biotherapeutics Description, Business Overview and Total Revenue11.4.3 Asterias Biotherapeutics Sales, Revenue and Gross Margin (2015-2020)11.4.4 Asterias Biotherapeutics Progenitor Cell Product Products Offered11.4.5 Asterias Biotherapeutics Recent Development11.5 Thermo Fisher Scientific11.5.1 Thermo Fisher Scientific Corporation Information11.5.2 Thermo Fisher Scientific Description, Business Overview and Total Revenue11.5.3 Thermo Fisher Scientific Sales, Revenue and Gross Margin (2015-2020)11.5.4 Thermo Fisher Scientific Progenitor Cell Product Products Offered11.5.5 Thermo Fisher Scientific Recent Development11.6 STEMCELL Technologies11.6.1 STEMCELL Technologies Corporation Information11.6.2 STEMCELL Technologies Description, Business Overview and Total Revenue11.6.3 STEMCELL Technologies Sales, Revenue and Gross Margin (2015-2020)11.6.4 STEMCELL Technologies Progenitor Cell Product Products Offered11.6.5 STEMCELL Technologies Recent Development11.7 Axol Bio11.7.1 Axol Bio Corporation Information11.7.2 Axol Bio Description, Business Overview and Total Revenue11.7.3 Axol Bio Sales, Revenue and Gross Margin (2015-2020)11.7.4 Axol Bio Progenitor Cell Product Products Offered11.7.5 Axol Bio Recent Development11.8 R&D Systems11.8.1 R&D Systems Corporation Information11.8.2 R&D Systems Description, Business Overview and Total Revenue11.8.3 R&D Systems Sales, Revenue and Gross Margin (2015-2020)11.8.4 R&D Systems Progenitor Cell Product Products Offered11.8.5 R&D Systems Recent Development11.9 Lonza11.9.1 Lonza Corporation Information11.9.2 Lonza Description, Business Overview and Total Revenue11.9.3 Lonza Sales, Revenue and Gross Margin (2015-2020)11.9.4 Lonza Progenitor Cell Product Products Offered11.9.5 Lonza Recent Development11.10 ATCC11.10.1 ATCC Corporation Information11.10.2 ATCC Description, Business Overview and Total Revenue11.10.3 ATCC Sales, Revenue and Gross Margin (2015-2020)11.10.4 ATCC Progenitor Cell Product Products Offered11.10.5 ATCC Recent Development11.1 NeuroNova AB11.1.1 NeuroNova AB Corporation Information11.1.2 NeuroNova AB Description, Business Overview and Total Revenue11.1.3 NeuroNova AB Sales, Revenue and Gross Margin (2015-2020)11.1.4 NeuroNova AB Progenitor Cell Product Products Offered11.1.5 NeuroNova AB Recent Development11.12 CDI11.12.1 CDI Corporation Information11.12.2 CDI Description, Business Overview and Total Revenue11.12.3 CDI Sales, Revenue and Gross Margin (2015-2020)11.12.4 CDI Products Offered11.12.5 CDI Recent Development 12 Future Forecast by Regions (Countries) (2021-2026)12.1 Progenitor Cell Product Market Estimates and Projections by Region12.1.1 Global Progenitor Cell Product Sales Forecast by Regions 2021-202612.1.2 Global Progenitor Cell Product Revenue Forecast by Regions 2021-202612.2 North America Progenitor Cell Product Market Size Forecast (2021-2026)12.2.1 North America: Progenitor Cell Product Sales Forecast (2021-2026)12.2.2 North America: Progenitor Cell Product Revenue Forecast (2021-2026)12.2.3 North America: Progenitor Cell Product Market Size Forecast by Country (2021-2026)12.3 Europe Progenitor Cell Product Market Size Forecast (2021-2026)12.3.1 Europe: Progenitor Cell Product Sales Forecast (2021-2026)12.3.2 Europe: Progenitor Cell Product Revenue Forecast (2021-2026)12.3.3 Europe: Progenitor Cell Product Market Size Forecast by Country (2021-2026)12.4 Asia Pacific Progenitor Cell Product Market Size Forecast (2021-2026)12.4.1 Asia Pacific: Progenitor Cell Product Sales Forecast (2021-2026)12.4.2 Asia Pacific: Progenitor Cell Product Revenue Forecast (2021-2026)12.4.3 Asia Pacific: Progenitor Cell Product Market Size Forecast by Region (2021-2026)12.5 Latin America Progenitor Cell Product Market Size Forecast (2021-2026)12.5.1 Latin America: Progenitor Cell Product Sales Forecast (2021-2026)12.5.2 Latin America: Progenitor Cell Product Revenue Forecast (2021-2026)12.5.3 Latin America: Progenitor Cell Product Market Size Forecast by Country (2021-2026)12.6 Middle East and Africa Progenitor Cell Product Market Size Forecast (2021-2026)12.6.1 Middle East and Africa: Progenitor Cell Product Sales Forecast (2021-2026)12.6.2 Middle East and Africa: Progenitor Cell Product Revenue Forecast (2021-2026)12.6.3 Middle East and Africa: Progenitor Cell Product Market Size Forecast by Country (2021-2026) 13 Market Opportunities, Challenges, Risks and Influences Factors Analysis13.1 Market Opportunities and Drivers13.2 Market Challenges13.3 Market Risks/Restraints13.4 Porters Five Forces Analysis13.5 Primary Interviews with Key Progenitor Cell Product Players (Opinion Leaders) 14 Value Chain and Sales Channels Analysis14.1 Value Chain Analysis14.2 Progenitor Cell Product Customers14.3 Sales Channels Analysis14.3.1 Sales Channels14.3.2 Distributors 15 Research Findings and Conclusion 16 Appendix16.1 Research Methodology16.1.1 Methodology/Research Approach16.1.2 Data Source16.2 Author Details

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Trending: Progenitor Cell Product Market Detailed Analysis of Current Industry Figures With Forecasts Growth by 2026 - Weekly Wall

Recommendation and review posted by Bethany Smith

A new study, lead by University of Wyoming Ph.D. candidate Melanie LaCava, has been studying the genetics of Wyomings pronghorn herds. Wyoming is home to roughly half of North Americas pronghorn population approximately 750,000 individuals. Their findings show that, despite multiple mountain ranges, three major highways, and ranges that span hundreds of miles, Wyomings pronghorn have little-to-no genetic differentiation. Despite the massive barriers across the state, in doesnt seem to have caused any changes amongst pronghorn.

On a genetic level, they all look pretty much alike.

The study included sample collection from 2014 thru 2019, examined genetic data of 398 male and female pronghorn across Wyoming, excluding Yellowstone and Grand Teton national parks. While certain surprising, this lack of diversity makes sense given how the animals behave. Pronghorn are social animals, but many do not live in the same groups for their whole lives. They enjoy a much more flexible social structure than Wyomings other hoof stock. Many dont even consistently migrate. To LaCava, it shows the connectivity of all of the states pronghorn. All the barriers, human or natural, have not stopped them from mingling with their peers. But this does not detract from the importance of preserving their migration corridors and core habitats we want to ensure their populations stay happy and healthy.

You can examine the full study Pronghorn Population Genomics Show Connectivity in the Core of Their Range in the online publication Journal of Mammalogy.

Follow this link:
Little to No Genetic Differentiation in Wyoming's Pronghorn | - mybighornbasin

Recommendation and review posted by Bethany Smith

The study on Global Male Breast Cancer Treatment Market, offers deep insights about the Male Breast Cancer Treatment Market covering all the crucial aspects of theMarket. Some of the important aspects analyzed in the reportincludesMarket share, production, key regions, revenue rate as well as key players. This Male Breast Cancer Treatment report also provides the readers with detailed figures at which the Male Breast Cancer Treatment Market was valued in the historical year and its expected growth in upcoming years. Besides, analysis also forecasts the CAGR at which the Male Breast Cancer Treatment is expected to mount and major factors driving Markets growth. This Male Breast Cancer Treatment Market was accounted for USD xxx million in the historical year and isestimated to reach at USD xxx million by the end of the forecast period, rising at a CAGR of xx%.

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Global Male Breast Cancer Treatment Market 2020 Technology Development, Industry Trends, Business Prospects, Top Key-Players, New Innovations and...

Recommendation and review posted by Bethany Smith

An irresponsible international food industry must shoulder a hefty part of the blame for COVID-19s deadly toll, say the authors of an editorial published yesterday in the BMJ. Moreover, to combat the parallel pandemic of obesity, governments need to step in to force reformulation of processed foods and prohibit the promotion of unhealthy eating that is causing so much morbidity and mortality worldwide, they say.

It's like tobacco, said Graham A. MacGregor, MB BChir, who co-authored the editorial with Monique Tan, PhD, and Feng J. He, PhD (all Queen Mary University of London, England). Why should the food industry be able to advertise things that are going to kill you?

Tan and colleagues review the evidence to date showing obesity to be an independent risk factor for more-severe illness and death following SARS-CoV-2 infection. These include a 428,225-patient cohort study showing that of 340 people requiring hospitalization, 44% were overweight and 34% were obese. Theres also the OpenSAFELY study, which looked at more than 12 million electronic records: among the 5,683 patients who died, 29% were overweight and 33% were obese. Both studies, note Tan et al, showed a dose-response relationship between excess weight and disease severity. In OpenSAFELY, the risk of dying from COVID-19 increased by 27% among obese individuals and was doubled in patients with a body mass index greater than 40.

I think people have recognized now that based on every study you look atincluding the early studies in China which were open studies, then from Europe, then from New Yorkthey all show that obesity increases the severity of COVID-19 and increases mortality, MacGregor observed.

Why should the food industry be able to advertise things that are going to kill you? Graham MacGregor

The only other major risk factors, he continued, are male sex and older age. If you're elderly and male and obese, I would be seriously worried and would do anything to try and lose weight and eat more healthily and take more exercise, MacGregor urged. Those are sensible things to do and the government should be encouraging people to do that, but of course they're not.

Speaking with TCTMD, MacGregor stressed that the blame rests with government and industry. One of the very clear messages that we want to give out, which is absolutely true, is that it's not the fault of the individuals that they are overweight; it's the fault of the food industry, because they promote all this very cheap processed foods that are made delicious by adding huge amounts of salt, sugar, and fat, and they then spend billions of pounds advertising this rubbish at very cheap prices, particularly targeted at socially deprived people and, not surprisingly, they're obese.

This allegation has particular resonance as protestors around the globe continue to call for an end to racism affecting the day-to-day lives of black, indigenous, and people of color who have also seen some of the highest levels of fatalities from COVID-19. In editorials and blogs, healthcare leaders have called on their colleagues to educate themselves about the problem and do their part to eradicate healthcare disparities.

There are a number of theories as to why obesity is amplifying disease severity. One is the chronic inflammatory state seen in obesity, which could play a role in the bodys altered immune response to SARS-CoV-2, potentially weakening the host defense and increasing the likelihood of the dreaded cytokine storm. A second possibility relates to the fact that angiotensin-converting enzyme 2 (ACE2), which SARS-CoV-2 uses to penetrate the cell membrane, is more common in people with obesity. Whether this is the result of higher ACE2 expression in the adipocytes of people with obesity or having more adipose tissue in general (and thus a greater number of ACE2-expressing cells) is not yet clear, the authors state.

A third possibility is the diminished lung function and difficulties with diaphragm contractility in people with massive abdominal obesity, creating more airway resistance and a lowered ability to fully expand the lungs. When patients with obesity need to be admitted to intensive care units, it is challenging to improve their oxygen saturation levels and ventilate them, Tan et al note.

Yet another option, potentially related to the immune system response, is genetics, MacGregor said, adding that this is an area of active investigation for which answers may come in a matter of months. But he dismissed the idea that an underlying genetic predisposition to obesity might also increase vulnerability to the virus. Obesity is only very rarely genetic, he insisted. Its an environmental disease, largely brought on by the food industry. The recent and ballooning numbers of obese people in China, India, and Vietnam as the fast-food and processed-food industries have started to flourish in these regions bear this theory out, he added.

Both MacGregor and He are involved with a range of blood pressure advocacy groups that have targeted high-sodium foods and added salt. Speaking with TCTMD, MacGregor used the successful salt reformulation campaigns in the United Kingdom as an example of what similar strategies targeting high-fat/high-calorie processed foods could accomplish with government support.

Of note, despite MacGregors longstanding interest in blood pressure, hes not convinced that hypertension on its own is an important risk factor for COVID-19, pointing to UK studies in which hypertension as a predictor for disease severity and death disappears after adjusting for age, race, sex, and obesity. Again, its early days and we are very cautious in drawing any conclusions from these [observational] studies because we're going to need much bigger studies, but my view is if blood pressure is a risk, it's a fairly small one compared to obesity, he commented.

Stop the Tide

MacGregor and colleagues conclude by calling on the food industry to immediately stop promoting high-fat, high-salt, high-sugar foods, and for governments to mandate the reformulation of unhealthy food and drink. Reducing salt, sugar, and saturated fat across the board would improve the diet of the entire population and bring even greater benefits for people who are most socially deprived, they write. The toll of morbidity and mortality from COVID-19 has made this more apparent and more urgent than ever.

Ironically, MacGregor said, at least in the UK, all the work that was going on to try and do something about obesity with the food industry has been abandoned because of the acute urgency of treating people with COVID-19.

The result has been a collision of two pandemics, he argued, the acute pandemic of COVID-19 and the chronic pandemic of obesity. And the two interact, MacGregor continued. Our feeling is that this is a time when governments need to act to do something not only about COVID-19 to try to stop the next wave of the infection or the current infection, but also to do something about obesity.

People with underlying obesity and obesity-related chronic diseases are at much higher risk for poor outcome: the virus may not be preventable, but those conditions are. Marion Nestle

Cardiologists have a role to play, he added. They should already be aware of the fact that unhealthy diet . . . is the biggest cause of death and disability in the world, he said. But we need to get many more physicians involved in trying to get their own governments and the food industry to do something about about preventing obesity rather than causing it, and COVID-19 has just brought that home again.

That message needs to be heard on the other side of the Atlantic as well, agreed Marion Nestle, PhD (New York University, NY), who commented on the editorial for TCTMD. The coronavirus pandemic has revealed a great deal about inequities and contradictions in food systems in the US as well as in the UK, she said in an email.People with underlying obesity and obesity-related chronic diseases are at much higher risk for poor outcome: the virus may not be preventable, but those conditions are.

What the pandemic has made clear, she added, is that preventing obesity is a societal responsibility, more than a personal one. It reveals the need to create food systems and food environments that support healthy eating and that make healthier foods more available, accessible, and affordable.

Regulation of the food industry, she added would help a lot with this.

Read more:
Obesity's Role in COVID-19 Deaths: Big Food, Slow Government to Blame? - TCTMD

Recommendation and review posted by Bethany Smith

For Yan Dekel and his husband, Alex Maghen - who host Daddy Squared: The Gay Dads Podcast - welcoming twin boys via surrogacy four years ago has been the biggest blessing of their lives.

"Our kids were born when I was 47 years old, and we decided to look into surrogacy when I was around 45 or 44," Alex told POPSUGAR. "I had always wanted to have children, but obviously one of the big differences between being a gay couple and a straight couple is that many straight couples can have a bottle of wine at dinner and nine months later a child is born. For a gay couple, it's often a much more careful and thoughtful process."

Related: After Years of Disappointment, Surrogacy Finally Gave Me the Chance to Be a Parent

Alex and Yan's reasoning for going the surrogacy route was straightforward: they wanted to have a genetic connection to their children. "Both Alex and I were very curious to see what our own genes would look like," Yan explained. "Part of my perception about having kids had a lot to do with the commitment I wanted to make to Alex. To me, my reason for wanting kids is very romantic. I wanted my genetics to be connected with Alex's forever so that if, God forbid, something happens between us, we'll always be together in a way."

"When the first child came out, we both burst out laughing because it was so obvious which kid had our DNA."

The pair enlisted the help of a surrogacy agency, which gave them access to a bank of women who were willing to donate their eggs. "We went through dozens of profiles and we came up with five finalists," Yan said. "Then we asked our closest friends and family to help us choose between the five. We ended up having three viable embryos: two male ones, which were given the quality grade of AA, and a girl one, which was graded BB. We froze them, and then waited to be matched with a surrogate. We were matched about four months after."

Although Yan and Alex didn't necessarily care about the sex of their children, they knew they wanted twins due to their age. Because of Yan and Alex's age, they wanted to try for two babies at once, and because they didn't care about their children's sex, they chose to implant the best-quality embryos. Having twins is considered to be a high-risk pregnancy, so representatives suggested trying for just one child at first. Set on having twins, they stuck to their original plan.

Story continues

"During stressful experiences, it's easy to turn over and allow the experts to tell you what to do," Alex said. "And I think it's important to feel confident that what your heart desires is what you want to get, and go for it."

"There are ways to save money, but it's definitely going to cost a lot of money."

Their surrogate gave birth to biological half-brothers: one boy's DNA comes from Yan, while the other's comes from Alex. And although the couple didn't want to know which son took after which dad, they figured it out the second the babies were born with one look at their hair. "Right before we went into the delivery room, the doctor told us that she was capable of doing an instant genetic test to tell which one was which," Alex explained. "We immediately said no and that we didn't care, except when the first child came out, we both burst out laughing because it was so obvious which kid had our DNA."

For these dads, few things were more surprising than how much biology played a part in everything from their children's mannerisms to the types of music they like. "It's really an amazing sociological experiment," Alex said. "Our boys are 4 years old and they've been raised the same way, they've had the same home environment, attend the same school, and they eat the same food, yet one of them conducts himself so much like me, and one of them conducts himself so much like Yan."

Yan agreed: "Alex and I sometime joke that we cloned ourselves. It's amazing to see how much genes hold. It's not only that they physically resemble us, but their personalities do, too - including their tastes in food! What's been amazing to me is that Alex's biological son sometimes speaks in a heavy Philadelphian accent when he's upset. Neither Alex nor I have this accent, but Alex's mother does since his family is originally from Philadelphia!"

Related: Surrogacy Was a More Emotional Journey Than I Ever Expected -but So Worth It

For parents considering surrogacy, the couple recommends that people weigh all their options before fully committing.

"There's a lot of research that you can and should do," Alex said. "It's also going to cost a lot of money. There are ways to save money, but it's definitely going to cost a lot of money, and that's something you have to be prepared for. In a cold, hard way of putting it, surrogacy is a lot like buying a house. It's a big expense. It's a big undertaking. It can be stressful. And I think that you need to go into it feeling confident that you know what you want and not allowing other people to tell you how to do it."

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2 Dads Share What It Was Like to Have Genetically Tied Twins Using a Surrogate - It's Incredible - Yahoo Lifestyle

Recommendation and review posted by Bethany Smith

Detraining is a natural physiological phenomenon that plays out in the body when an athlete ceases regular training. Any swimmer who has ever followed an intense season with a 2-3-week break and then returned to face the music will know what whats gained in three weeks is lost in a day feels like.

Forced lockdown during COVID-19 has broughtdetraining into sharp focus as swimmers, coaches and programs make their way back to water and pool deck.

To use the words of Pieter van den Hoogenbands dad Dr Cees-Reinvan den Hoogenband:

detraining results in a diminished efficiency of heart and lungs to transport oxygen and use this in active muscles (i.e. reduced cardio-respiratory efficiency, and a diminished capacity of skeletal muscle to display strength, flexibility and endurance (i.e. reduced musculoskeletal capability). Given the changes in energy expenditure, individual nutritional requirements will also change.

Dr. Van den Hoogenband, in his role as the chairman of the FINA Sports Medicine Committee advising the FINA COVID-19 Task Force backed by guidance from the World Health Organisation(WHO) and Government Agencies, issued a statement this week to coincide with the permissions being granted or considered by Public Health Authorities in many countries for a limited return to swimming pools and on the understanding that hygiene measures, hand washing, physical distancing and contact tracing initiatives are observed.

As we noted in a two-art feature with water health and hygiene expert Dr. Vincenze Spica (part 1 ; Part 2), there are reasons to be optimistic, reasons why elite swimming in control conditions can be revived. There are also, say scores of experts, cautionary measures that need to be observed at a time when more needs to be known about the nature of the novel coronavirus behind the current pandemic in which 7.6m people have been infected and more than 424,000 have died as a result of COVID-19, according to official registered statistics.

In his nite to swimmers, coaches and programs, Dr. Van den Hoogenband raises an issue critical to the health, welfare and successful return of athletes. He writes:

The SMC respectfully reminds all stakeholders that athletes, forced into an unprecedented and prolonged break from habituated training routines, may experience the physical effects of detraining.

For professional athletes with access to expertise in sports science and medicine, we understand that these issues will have already been anticipated and, to some extent, minimised by land-based exercise. However, many FINA athletes do not enjoy these privileges and it is inevitable that all athletes will be affected to some extent. Sport specific fitness for aquatic athletes can only be fully achieved through water-based activities.

The SMC wishes to raise these issues for the benefit of all aquatic athletes. We advise a gradual resumption of training, balancing water-based and land-based activities and increasing these elements slowly, starting with low and medium intensity exercise. This will allow your body to readjust and minimise the risk of overuse injury through failure to adapt to increasing workload. Rising energy demands of training will also require appropriate nutritional intake.

We also appreciate the psychological impact the COVID-19 pandemic has had on athletes, affecting normal interactions and routines, and as a consequence of postponement or cancellation of FINA events. Return to competition fitness will take several months and FINA will take this into account when making future decisions.

As Dr Van den Hoogenband noted, many of the worlds best swimmers and their coaches have access to experts and good resources when it comes to detraining. Iigo Mujika, the physiologist who works with coach Fred Vergnoux and team at Spanish swimming, is among those who has long considered the theme in academic work that feeds into the coaching of world-class swimmers, among other athletes.

Detraining is nothing new. Back in the days of the GDR, swimmers were detrained for up to two years after their last races, Kornelia Ender revealing back in 1993 in an interview with this author that she swam down and eased out of the sport over a period of almost two years. Part of the reason for that, according to medical papers recovered from Stasi (state police) files after the fall of the Berlin Wall in 1989, was to attempt to reverse the androgenization of girls fed steroids since they were 13 years old. The issues raised are relevant to the current debate on gender in sport. Like so many things in this world, there is a light and dark side to the coin of knowledge.

Understanding detraining and taking the theme into account as swimming programs embrace a steady revival speaks to the best interests of athletes (including those who were abused with doping from a young age). Science developed in the GDR in what was the biggest experiment ever undertaken on athletes (an estimated 10,000 were affected), made its way to the library of understanding in world swimming long ago. Science does not stand still, of course, and much more has been learned since Ender and Co were swum down.

In 2001, Mujika co-authored a paper with Sabino Padillain which they considered the Cardiorespiratory and metabolic characteristics of detraining in humans (available free at that link). They wrote:

Detraining can be defined as the partial or complete loss of training-induced adaptations, in response to an insufficient training stimulus. Detraining is characterized, among other changes, by marked alterations in the cardiorespiratory system and the metabolic patterns during exercise. In highly trained athletes, insufficient training induces a rapid decline in O2max, but it remains above control values. Exercise heart rate increases insufficiently to counterbalance the decreased stroke volume resulting from a rapid blood volume loss, and maximal cardiac output is thus reduced. Cardiac dimensions are also reduced, as well as ventilatory efficiency. Consequently, endurance performance is also markedly impaired.

These changes are more moderate in recently trained subjects in the short-term, but recently acquired O2max gains are completely lost after training stoppage periods longer than 4 wk. From a metabolic viewpoint, even short-term inactivity implies an increased reliance on carbohydrate metabolism during exercise, as shown by a higher exercise respiratory exchange ratio. This may result from a reduced insulin sensitivity and GLUT-4 transporter protein content, coupled with a lowered muscle lipoprotein lipase activity. These metabolic changes may take place within 10 d of training cessation. Resting muscle glycogen concentration returns to baseline within a few weeks without training, and trained athletes lactate threshold is also lowered, but still remains above untrained values.

Their conclusion reads: Detraining, defined as the partial or complete loss of training-induced adaptations in response to an insufficient training stimulus, may take place within short periods of training cessation or marked reduction in habitual physical activity level. Short-term cardiorespiratory detraining is characterized in highly trained athletes by a rapid O2max decline, but it usually remains above sedentary values. O2max decreases to a lesser extent in recently trained subjects in the short run, but training-induced gains are most often completely reversed when training is stopped for a period longer than 4 wk. The O2max loss is the outcome of an immediate reduction in total blood and plasma volumes, the latter being caused by a reduced plasma protein content.

Even though exercise heart rate increases at both maximal and submaximal intensities, this is not sufficient to counterbalance the reduced stroke volume, and maximal cardiac output declines. Cardiac dimensions often decrease, blood pressure increases, and ventilatory efficiency is most usually impaired after periods of training cessation. This general loss in cardiorespiratory fitness results in a rapid decline in the trained athletes endurance performance. Recently acquired endurance performance gains, on the other hand, can be readily maintained for at least 2 wk without training.

From a metabolic perspective, even short-term detraining is characterized by a higher reliance on carbohydrate as a fuel for exercising muscles, as indicated by an increased respiratory exchange ratio. Whole-body glucose uptake is reduced, because of a decline in insulin sensitivity and a reduced muscle GLUT-4 transporter protein content, both in athletes and in recently trained individuals. In addition, muscle lipoprotein lipase activity decreases. Exercise blood lactate concentration increases at submaximal intensities, and the lactate threshold is apparent at a lower percentage of O2max. These changes, coupled with a base deficit, result in a higher postexercise acidosis. Finally, muscle glycogen concentration suffers a rapid decline, reverting to sedentary values within a few wk of training cessation.

Dr. G. John Mullen recently published the highlights of a conversation he had with Dr. Rodrigo Zacca, Ph.D, a Postdoctoral Researcher of Universidade do Porto in Portugal. Dr. Zacca studied the Effects of detraining in age-group swimmers performance, energetics and kinematics.

On his Swimming Science blog, Dr. Mullenpenned the 9 Things you Didnt Know about Swimming Detraining as a result of his conversation with Dr. Zacca. Here are the seven themes covered (read the article in full at Swimming Science for the detail):

Swimming Impairs: the main conclusions of this study suggest that detraining after four-weeks of pool-based training cessation can impair swimming performance at the start of the following training season in age-group swimmers, underlining the importance of maintaining fitness levels during off-season or swimming detraining.

3.8% Impairment: The 400-m front crawl performance of 1415 years old competitive swimmers was impaired by ~3.8% after four-weeks of training cessation

No Effects from Growth: Four-weeks was not long enough to detect growth effect on performance, but impairment of 400m front crawl performance was attenuated by those swimmers who were more physically active during the off-season.

Elite Swimmers 4-Week Detraining: For elite swimmers, there are three interesting studies.

High-Intensity Maintains Performance: Non-swimming specific physical activities during the offseason or swimming detraining accounted for 40% of the total variance in performance, showing good partial correlation with impairment in performance

How Long to Get In Swimming Shape After Covid-19: Many factors will influence the length of time for recovery from Covid-19. Size and speed to reverse these losses after the #Covid19 will depend on many aspects, such as current fitness level, training history, age, specificity of previous training, and even genetics (Mujika and Padilla 2000-01; Abrahin et al. 2019). However, since the pandemic is not over yet and we do not know when it will end, its time to attenuate the impairments in performance. Those who manage to remain more active (in a creative and intelligent way) will have fewer problems after this pandemic period.

Other Tips on Limiting Impairments from Swimming Detraining: First, dont stand waiting for the end of pandemic, as the impairments can be irreversible Second, be creative to create alternatives, but be intelligent (specificity matters a lot).

Dr Mullen notes that study of detraining and related issues was not the exclusive preserve of sport and the theme dovetails with other important factors in performance swimming, such as injury, health, disease; Taper; Off-season; and now a pandemic.

Understanding the effects of training reduction and cessation is of interest to other communities and society in general, writes Dr Mullen, noting the importance of the issue to the military, aerospace industry, care for and wellbeing of the elderly and the bedridden and those who suffer from conditions involving the loss of autonomy, including ageing, muscle disorders and related disabilities).

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Why Detraining Is At The Heart Of The Swimming Playbook In Covid-19 Season 2020 - Swimming World Magazine

Recommendation and review posted by Bethany Smith

There may be more value gleaned from the use of broad-panel next-generation sequencing (NGS) than from the use of a single-gene testing (SGT) approach in patients with nonsquamous non-small cell lung cancer (nsNSCLC), researchers argued in a presentation during the ASCO20 Virtual Scientific Program.1

Even though EGFR and ALK-based testing is widely used in NSCLC with a combined SGT rate for these mutations approaching 80% in patients with nonsquamous histology across community oncology practices in New Jersey and Maryland, according to a retrospective analysis of the COTA database2 larger screening panels interrogating for other actionable driver oncogenes (ADOs) may actually be more cost-effective in the long run.

The goal of the simulation, led by Nathan A. Pennell, MD, PhD, of the Cleveland Clinics Taussig Cancer Center in Ohio, was to measure the cost and/or value differences between choosing to run a narrow genomics panel or broader NGS. They measured the potential value of each testing approach on the basis of life years gained (LYG) and the cost per LYG.

They considered the rates of reimbursement by the Centers for Medicare & Medicaid Services (CMS) for both a broad NGS test ($627.50) and 2 single gene tests (1 test for ALK and 1 test for EGFR; $732.30), and the cost of treatment for 2 years afterward (which they estimated would be approximately $20,000).

The researchers estimated the prevalence of ADOs across nsNSCLC (89,000 nsNSCLC patients who would be eligible for testing annually) and then predicted survival outcomes in both the presence and absence of an ADO-based prescribing approach using the rates found in the existing literature. These survival estimates for each group were based on Weibull distributions fit to statistical estimates of both median and 5-year survival.

The model was based on the assumption that if there were an appropriate match for ADO and the patient subsequently received a targeted therapy as a result of the testing, the patient would gain a median additional 2 years of life.

ADOs of interest that were a part of the broader panel included EGFR, ALK, ROS1, BRAF, RET, MET, and NTRK, whereas SGT could only include interrogate for either ALK or EGFR.

Compared with the use of SGT, a more blanketed NGS approach to testing for genetic aberrations was determined to produce large gains in life years at reduced cost per LYG, the authors wrote.

Assuming the genetic testing rate in this patient population remains at 80%, a switch from SGT to a wider adoption of NGS would result in an additional 21,019 LYG with reduced cost per LYG of $599. And if NGS were universally performed for nsNSCLC, the value would rise even higher.

In addition, not running these multigene tests in a routine manner, the reseearchers argued, could be a missed opportunity it could mean that actionable mutations would be missed by only using SGT, and patients may not get the best therapy for their disease as a result.

Thus, the investigators concluded, the estimated median survival and 5-year survival for a patient who received NGS followed by a highly effective therapy selected on the basis of that alteration was 39 months and 25%, respectively. The survival estimates would be 14 months and 25%, respectively, for a patient who had an ADO that was not identified by SGT.

Read more of Cancer Therapy Advisors coverage of the ASCO 2020 meeting by visiting the conference page.

Reference

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Researchers Present Evidence in Support of Broad Next Generation Sequencing in Advanced Nonsquamous NSCLC - Cancer Therapy Advisor

Recommendation and review posted by Bethany Smith

Global Direct-To-Consumer (DTC) Genetic Testing Industry Competitive Analysis -Forecast and Historical Market Analysis by Key Market Segments

The globalDirect-To-Consumer (DTC) Genetic Testing marketreport is updated and is published by theMarket Research Store. Detailed information about the Direct-To-Consumer (DTC) Genetic Testing market is included which is updated according to the recent outbreak of COVID-19. The data that is provided in the report study consists of historical data from 2016 to 2019 and also forecasts the further market conditions from 2020 to 2026. The Direct-To-Consumer (DTC) Genetic Testing market report study consists of over 150 pages and has over 30 tables and above 20 figures.

Request Free Sample Copy of Direct-To-Consumer (DTC) Genetic Testing Market Research Report@http://www.marketresearchstore.com/report/global-direct-to-consumer-dtc-genetic-testing-market-295322#RequestSample

All the market players that are operating in the Direct-To-Consumer (DTC) Genetic Testing market is incorporated. Some of the major players that are included within the report areGeneByGene, Genetrainer, Genecodebook Oy, Myriad Genetics, MD Revolution, DNA DTC, 23andMe, Navigenics, DeCODEme. All the details about the organization are included for having clear idea about the market competitiveness.

The Direct-To-Consumer (DTC) Genetic Testing market report consists of market definition and overview. The target audience for the market is also included for better understanding the market scenario. The research analysts have conducted several primary and secondary researches in order to obtain the numerical for the Direct-To-Consumer (DTC) Genetic Testing market. The compound annual growth rate of the Direct-To-Consumer (DTC) Genetic Testing market is revised and updated in the report study. This is owing to the changed market conditions amidst COVID-19. Several research methodologies and tools were used for further validating the data that was obtained through these researches.

Read Detailed Index of full Research Study at@::http://www.marketresearchstore.com/report/global-direct-to-consumer-dtc-genetic-testing-market-295322

The growth factors of the Direct-To-Consumer (DTC) Genetic Testing market are included along with detailed information about the market drivers. The market restraints are also included along with supporting facts. In the coming years, the Direct-To-Consumer (DTC) Genetic Testing market will have to face several challenges but there will also be opportunities for the market to grow in the coming years. All these factors are also included in the study.

The Direct-To-Consumer (DTC) Genetic Testing market segmentation includes{Genome Data Bank Material Model, Individual Health Planning Model, Comprehensive Genome Tests Model, Medical Precision Tests Model, Restricted Trait Tests Model}; {Hospital, Doctors Office, Other}. In-depth study has been conducted about each and every segment of the market. The information in the report is depicted in subjective form as well as using tables and pictorial representations. This aids for better understanding of the Direct-To-Consumer (DTC) Genetic Testing market. The regional representations are also included. Global market analysis, region-wise and country-wise market analysis is also included within the dossier.

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The key highlights of the report:

1) Market driver, barriers, opportunities, and challenges2) Industry development3) Key regulations and mandates4) Patent analysis5) Value chain analysis6) Porters five forces model7) PESTLE and SWOT analysis8) Competitive landscape9) Investment opportunity analysis10) List of distributors/traders and buyers

Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.(*If you have any special requirements, please let us know and we will offer you the report as you want.)

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COVID 19 Impact On Global Direct-To-Consumer (DTC) Genetic Testing Market 2020 | Analysis By Key Players | GeneByGene, Genetrainer, Genecodebook Oy,...

Recommendation and review posted by Bethany Smith

The global hereditary cancer testing market is US$ 3,967.74 Mn in 2018 and is predicted to grow at a CAGR of 11.1% during the forecast period 2019 2027, to reach US$ 9,840.52 Mn by 2027.

Asia Pacific is the fastest growing geographic market and is expected to be the significant revenue contributor in forecast period. The region has witnessed several technological advancements in the field of healthcare by the incorporation of advanced hereditary cancer screening for rising hereditary cancer prevalence in the region. There is a growing interest of international players in China and India, government support in countries such as China, and advancing healthcare infrastructure. Therefore, the region has huge potential for the hereditarycancer testing marketplayers to grow during the forecast period.

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Global hereditary cancer testing market, based on the diagnosis type, was segmented as, biopsy and imaging.In 2018, the imaging segment held a largest market share of the hereditary cancer testing market, by diagnosis type. This segment is also expected to dominate the market in 2027 owing to the increasing number of cancer patients. Moreover, imaging segment is expected to grow at significant rate, in the forecast period 2019 to 2027 owing to rising preference towards cost-effective, easy, and accurate method for hereditary cancer testing.

The major players operating in the hereditary cancer testing market include Hologic Inc., Koninklijke Philips N.V., Quest Diagnostics Incorporated, Myriad Genetics, Inc., Cancer Genetics Inc., Invitae Corporation, Myogenes, Strand Life Sciences Pvt. Ltd., Pathway Genomics Corporation, and CENTOGENE AG, among others.

The market has witnessed various organic as well as inorganic developments during recent years in the hereditary cancer testing market. For instance, during April 2019, Hologic, Inc., launched the Trident HD specimen radiography system. It is a next-generation solution that delivers improved image quality, better workflow, and instant sample verification during breast-conserving surgeries and stereotactic breast biopsies. The product launches enable companies to expand their corresponding product portfolios and increase the customer base worldwide.

The market for hereditary cancer testing is expected to grow, owing to factors such as increasing prevalence of hereditary cancer and growing awareness about hereditary cancer have been boosting the market over the years. In addition, growing demand for noninvasive methods of detection are likely to have a positive impact on the growth of the market in the coming years.

Although, the genetic testing of various metabolic liabilities of cancer is clinically accessible, the available data suggest that a limited population is aware about these tests. The awareness regarding hereditary cancer conditions is growing due to various efforts made by the government. In the past decade, public medical, health, and scientific communities invested in spreading awareness regarding hereditary cancer conditions, with a major focus on hereditary cancer risk, family history, and genetic testing for inherited cancer liability. Direct-to-consumer (DTC) publicity of cancer genetic testing and federal regulations of genetic information have been other factors driving cancer genetic testing awareness among people. For instance, Myriad Genetics Laboratories, Inc. (Myriad), launched various DTC campaigns in major cities in US in the past decade. Moreover, multiple companies provide genomic profiling services for health assessment, including cancer risk prediction. Thus, increasing awareness regarding genetic cancer would enhance the demand for the diagnostic tests, along with improving the quality and efficacy of hereditary cancer testing during the forecast period.

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Hereditary Cancer Testing Market New Innovative Solutions To Boost Global Growth With Top Key Players- Cancer Genetics, Myogenes, Strand Life...

Recommendation and review posted by Bethany Smith

The troubled Mixed-oxide Fuel Fabrication Facility project at the Savannah River Site is proposed to be transformed into a plutonium pit production facility. Photo (c) Timothy Mousseau, 2019.

The National Nuclear Security Administration (NNSA), the organization within the Energy Department that is responsible for producing and maintaining US nuclear warheads, is moving forward with a plan to build a plutonium-pit-production factory at DOEs Savannah River Site in South Carolina. Pits are the form of the plutonium in the fission trigger primaries of US two-stage nuclear warheads.

The primary motivation for this move is lack of confidence in the pit-production capacity at Los Alamos National Laboratory, which has been responsible for preserving US pit production expertise since production at the Rocky Flats Plant outside of Denver shut down at the end of the Cold War. There are also political motivations, including filling the jobs gap at the Savannah River Site resulting from the collapse of NNSAs effort to build a Mixed-oxide Fuel Fabrication Facility there to process some of its excess Cold War plutonium pits into power reactor fuel.

NNSAs rush forward may result in a debacle on top of a debacle. If the experts at Los Alamos cant manage pit production there, why does NNSA think that they can design and train the staff to operate a pit-production facility at the Savannah River Site?

Also, the United States need for pits is unclear at the moment. In 2007, the pits produced at Rocky Flatsnow 30 to 40 years oldwere pronounced to be good for at least a century and, in 2012, the Lawrence Livermore National Laboratory upped the durability estimate to 150 years. NNSA did not support the necessary research to solidify this conclusion, howeveran oversight that it now promises to remedy.

The NNSA also claims that it needs to produce new pits for two types of safer primaries for two new nuclear warheads, but there seem to be enough already-existing pits for one of the warheads, and the design for the second has not yet been decided.

Thus, there are multiple arguments for delaying a decision on the proposed second pit-production facility for a decade or so. By then, Los Alamos should have mastered the production of pits, the longevity of the legacy pits will be better established, and the need for pits not available in the legacy stockpile should be clarified.

Pits, the critical components. Each US nuclear warhead contains a miniature advanced version of the Nagasaki nuclear bomb weighing only about two percent of what the original Nagasaki bomb weighed. This primary is built around a hollow shell of plutonium, which is surrounded by chemical explosive.

If that explosive is triggered, the pit will be imploded rapidly into a spherical solid mass compressed to perhaps twice the normal density of plutonium. Near the point of maximum density, before the plutonium begins to bounce back to its normal density, a small neutron generator will spray it with a burst of neutrons that will initiate exponentially multiplying fission chain reactions. Within a microsecond, about 20 grams of the plutonium will fission, releasing energy equivalent to the explosion of about 300 tons of TNT, heating the material in the primary to about a million degrees Centigrade.

At that temperature, fusion reactions will occur in the several grams of tritium and deuterium that were injected into the hollow pit just before the implosion. Those fusion reactions will produce an intense burst of neutrons that fission hundreds more grams of plutonium, boosting the energy of the fission explosion to the equivalent of about 10,000 tons of TNT, half the power of the Nagasaki bomb.

At that point, the primary will be so hot that its glow will be mostly X-rays that will fill the radiation case surrounding the primary and a secondary nuclear explosive nested next to it. The X-rays will vaporize the outer layer of the secondary, imploding and heating it and igniting a mix of fusion and fission reactions that, depending on the warhead, will release from a few times to 25 times the energy of the Nagasaki bomb from a warhead about one-twentieth the weight of the 4.4 ton Nagasaki bomb.

Will aging pits still work? The last nuclear test of a US primary was conducted in 1992, when Congress imposed a moratorium on US nuclear testing, launching negotiations on the Comprehensive Test Ban Treaty, which the United States signed in 1996. The treaty has not come into force because eight countries, including the United States, have not ratified it; nevertheless, it appears to have moral if not legal force. No country other than North Korea has tested a nuclear weapon since 1998, and North Korea stopped in 2017.

Despite the lack of US testing, there is no doubt that the primaries in US nuclear warheads will implode or that, if the primary works, the secondary will explode. The issues that have been raised relate to whether the plutonium might become brittle and fragment as it implodes, and whether, if that happened, the tritium-deuterium boost gas would ignite. The NNSA spends billions of dollars each year investigating this question with ever-more-refined computer simulations of what happens inside a pit during its implosion and tests of the behavior of aging plutonium under shock, including in subcritical tests in tunnels deep under the former Nevada Test Site.

Every year, the three NNSA weapon labsLivermore, Los Alamos, and Sandiaand the US Strategic Command, which would deliver most US warheads in a nuclear war, go through an elaborate review process of the condition of the warheads and of the simulations, including by red teams of skeptics, before they certify to Congress, via the secretaries of Defense and Energy and then the president, that they are confident the warheads would work and that no tests are required.

During the Cold War nuclear arms race, pits and other weapon components were replaced regularly as one generation of nuclear weapons succeeded another. That evolution stopped with the end of nuclear testing. Today, most of the US warheads have undergone or are going through a life-extension process, with most components being replaced. The pits themselves are not yet being replaced, however. The United States has not been making new pits in significant numbers since 1989 when the FBI and Environmental Protection Agency raided the Energy Departments pit production plant at Rocky Flats outside Denver for environmental crimes. The plant was subsequently razed. (See former Bulletin editor Len Acklands 1999 book, Making a Real Killing: Rocky Flats and the Nuclear West.

That the US is not able to replace the pits has become a perennial point of anxiety for the US nuclear-weapon establishment and its congressional overseers. Proposals have been made, but no new pit production facilities have been builtin part because the pits made by Rocky Flats have proven remarkably durable. They are sealed and plated, and they have suffered virtually no corrosion. The main question is whether the emission of alpha particles (helium nuclei) by the slow decay of the plutonium is changing the mechanical properties of the material.

In 2005, Congress directed the NNSAs administrator to commission an independent review of the efforts at the Los Alamos and Lawrence Livermore laboratories to estimate pit lifetimes. The review was carried out by JASON, a group of experts, mostly academics, who do summer studies on issues of interest to the Defense and Energy departments. An unclassified summary of the groups findings was released in early 2007.

Los Alamos and Livermore had been analyzing the effects of plutonium aging on the functionality of US pits. They also had been doing accelerated-aging experiments on samples of the plutonium alloy used in US pits by spiking them with plutonium-238, which decays by alpha emission with a half-life of 88 years, versus the 24,000 years for the dominant isotope in weapon-grade plutonium, Pu-239.

The summary conclusion of the 2007 JASON report was:

We judge that the Los Alamos/Livermore assessment provides a scientifically valid framework for evaluating pit lifetimes. The assessment demonstrates that there is no degradation in performance of primaries of stockpile systems due to plutonium aging that would be cause for near-term concern regarding their safety and reliability. Most primary types have credible minimum lifetimes in excess of 100 years as regards aging of plutonium; those with assessed minimum lifetimes of 100 years or less have clear mitigation paths that are proposed and/or being implemented.

The JASON report also recommended additional research (pp. 17-18):

to gain experience with Pu that has suffered the equivalent of a century or more of aging (i.e., with accelerated aging), thereby allowing an interpolation rather than an extrapolation in estimating performance changes and degradation due to aging. In particular, one wants to know the modes of failure that will be among the first to appear, because these can inform the stockpile surveillance program in order to make it most sensitive to aging-induced degradation [and] ongoing study of the current accelerated-aging Pu samples, which are spiked with the rapidly-decaying 238Pu, as well as production of samples that have been aged by alternative means. In all of these cases, the objective is to get the equivalent of multi-century experience on aging phenomena, associated with decay (e.g., radiation damage) as well as with activated processes such as annealing.

Some work on accelerated aging did continue and, in 2012, the Livermore lab reported, no unexpected aging issues are appearing in plutonium that has been accelerated to an equivalent of ~ 150 years of age.

Livermores deputy program leader for enhanced surveillance of pit aging stated, In the near term, the nation can save tens of billions of dollars that might be required to build a new production facility.

Pit-production problems at Los Alamos. In 1999, to maintain US pit-production expertise, the Energy Department instructed Los Alamos to establish pit production capacity of up to 20 pits per year within its large PF-4 plutonium facility. Surprisingly, however, despite the history of Rocky Flats having routinely produced 1,000 to 2,000 pits per year, Los Alamos has struggled to produce a small number of pits, even though the lab has spent billions of dollars on pit-production efforts.

In 1996, the Energy Department tasked Los Alamos to produce 31 war reserve pits for the W88, the high-yield warhead for US ballistic missile submarines, for an order that had not been completed because of the shutdown of the Rocky Flats plant. It took 16 yearsuntil 2012to fabricate the pits. Eleven were produced in 2007 but then a declining number annually thereafter.

The plan was to transition to producing pits for additional W87 warheads for the US Minuteman III intercontinental ballistic missile. In 2013, however, pit production at Los Alamos was shut down because of inadequate worker safety training and concerns about potential plutonium criticality accidents. Seven years later, pit production is still shut down at Los Alamos and the expectation is that this situation will continue until 2023.

NNSAs budget submission for fiscal year 2021 states that Los Alamos is engaged in activities to hire, train, qualify, and retain required pit production personnel, recapitalization of equipment needed to restore Plutonium Facility (PF)-4s ability to produce War Reserve (WR) [pits,] towards producing the first WR pit during 2023 [and] manage capital acquisitions to increase production capability of PF-4 to produce 10 pits per year.

The cost of the planned upgrades to PF-4 is estimated at $1.75 billion through fiscal 2025.

Eighty pits per year? In 2008, the departments of Defense and Energy decided that the United States needed a pit production capacity of 50 to 80 pits per year. This range was based on the very rough computation that it would take 30 to 90 years to replace the pits in a US stockpile of 2,500 to 4,500 warheads at that rate. It was assumed that the production could be carried out at Los Alamos.

But Los Alamos continued to flounder. In 2014, Congress backed the goal of 50 to 80 pits per year with a sense of Congress statement (which does not have the force of law) backing a requirement of a production capacity of 30 pits per year by 2026 and a demonstration over 90 days during the following year of a production rate of 80 pits per year. In 2019, the date of that goal slipped to 2030, but, in the Defense Authorization Act of 2020, Congress added the message that any further delay to achieving a plutonium sustainment capability to support the planned stockpile life extension programs will result in an unacceptable capability gap to our deterrent posture.

The Trump administrations 2018 Nuclear Posture Review which also does not have the force of law turned these various assertions into a requirement for an enduring capability and capacity to produce plutonium pits at a rate of no fewer than 80 pits per year by 2030.

Two pit production facilities? After an initial expenditure of $7 billion on construction of a Mixed Oxide Fuel Fabrication Facility at the Savannah River Site to fabricate excess Cold War plutonium into reactor fuel, the cost continued to grow: It was estimated that the cost to completion of that NNSA project had climbed to $30 billionfor a program that Congress had originally been told would cost $2 billion. Congress voted to shut the project down and, in early 2018, the Trump Administration agreed, raising the question of what to do with the fortress structure that had been built and how to compensate the South Carolina delegationespecially its powerful leader, Sen. Lindsey Grahamfor the loss of jobs the cancellation of the MOX plant entailed.

In this context, the idea was born to divide the pit-production mission between Los Alamos and Savannah River.

In 2018, the Defense Department and the NNSA issued a joint statement asserting that there would be two pit-production facilities: one at Los Alamos producing at least 30 pits per year and one at Savannah River producing at least 50 pits per year. In this way, the 2008 goal of demonstrating a production capability of 50 to 80 pits per year at Los Alamos had 10 years later become a minimum combined production rate of 80 pits per year at Los Alamos and Savannah River.

Updating the pit durability estimate. Meanwhile, the question remained as to what a decade of additional research at Los Alamos and Livermore had revealed about the lifetimes of the legacy pits.

In March 2018, the Senate Appropriations Committee, in its report on the Energy and Water Appropriations Act for fiscal 2019, directed the NNSA administrator to contract with JASON to do an update on its 2007 report on expectations for the longevity of the Rocky Flats legacy pits. The instruction was that JASON should be contracted to assess the efforts of the NNSA to understand plutonium aging and the lifetime of plutonium pits in nuclear weapons [and] include recommendations of the study for improving the knowledge, understanding, and application of the fundamental and applied sciences related to the study of plutonium aging and pit lifetimes, an estimate of minimum and likely lifetimes for pits in current warheads, and the feasibility of reusing pits in modified nuclear weapons. The report shall be submitted in unclassified form but may include a classified annex.

The Senate instructed the NNSA administrator to make available all information that is necessary to successfully complete a meaningful study on a timely basis.

A year and a half later, in November 2019, after a near-death experience at the hands of the Trump administration, JASON submitted a three-page letter report informing Congress that it could not update its previous estimate because, in general, studies on Pu aging and its impacts on the performance of nuclear-weapon primaries have not been sufficiently prioritized over the past decade. A focused program of experiments, theory, and simulations is required to determine the timescales over which Pu aging may lead to an unacceptable degradation of primary performance.

The JASON letter also suggested that, contrary to Congresss instruction, NNSA had not cooperated adequately with the review: The labs briefly presented their program to address Pu aging to JASON. The plan seemed sensible, but a detailed JASON assessment would require additional information about the program as well as technical details.

Laudably, NNSA was embarrassed and, in April 2020, administrator Lisa E. Gordon-Hagerty informed the chairman of the Senate Armed Services Committee Subcommittee on Strategic Forces that her agency planned to fund a second phase of the JASON study during the summer of 2020 to [a]ssess the need for the full study, and if deemed necessary and timely, perform a more detailed, multi-year JASON study.

The letter also stated that NNSA has launched an enhanced program focused on understanding the potential effects of plutonium radioactive decay, or aging, on pit performance.

Other needs for new pits? In addition to the potential need to replace pits because they are aging, NNSA also is advocating the new production facility to produce pits with enhanced safety features to meet NNSA and DoD requirements.

This quest goes back 30 years, to the launch of the Stockpile Stewardship Program by the Clinton Administration. At the time, the weapon labs proposed to replace the W78 ICBM warhead and the W76 and W88 submarine-launched ballistic missile (SLBM) warheads with new warheads containing insensitive high explosive. That proposal has been sustained over the decades since through a number of incarnations, including proposals for warheads that would be interoperable between the ICBMs and SLBMs.

The purpose of insensitive high explosive is not to reduce the probability of an accidental nuclear explosion. Other elements of the safety design are supposed to do that, and, to date, no warhead accident has resulted in a nuclear yield.

The benefit from the use of insensitive high explosive would be to reduce the number of accidents in which the chemical explosive around a pit is detonated and plutonium is dispersed. There were many such accidents involving aircraft-carried warheads prior to the decision not to fly nuclear-armed aircraft in peacetime. The most famous was the collision of a nuclear-armed B-52 strategic bomber with its refueling tanker over Spain in 1966, which resulted in a large area of plutonium contamination on the ground, requiring 1,600 US military personnel to be deployed for up to 12 weeks, working with minimal protection, gathering contaminated dirt and crops into barrels for shipment back to the US for burial on the Savannah River Site. The Navy has had no such accidents with its SLBM warheads, however, and believes that reducing the risk significantly would require redesigning its Trident missile as well as their warheads. It therefore has in the past not been willing to invest in adapting new insensitive high explosive warheads to its missiles, a process that would include flight tests.

It appears, however, that the Navy has finally acquiesced or been overruled on this matter, and the plan is to replace its two SLBM warheads, the W76 and W88, with new warheads that use insensitive high explosive.

The current proposal is to build two new warheads. The first is the W87-1, which would replace the W-78 on the Ground-Based Strategic Deterrent, the successor to the Minuteman III missile, and potentially also the W-88, the high-yield warhead on the Trident II submarine-launched ballistic missile. A second warhead, sometimes referred to as the W93, would replace the W76.

The pit of the W87-1 would be identical to the pit of the W87-0, which is currently deployed on the Minuteman III, and is to be used on the Ground-based Strategic Deterrent. The 400 Minuteman IIIs are to be replaced one-for-one with the new ICBM, which, like the Minuteman III, is to be deployed with only a single warhead per missile.

The Defense Department reportedly has 540 W87-0s in stock, of which 200 are deployed on the Minuteman III along with 200 W78s. Therefore, the W78s could be replaced with stored W87s. The department wishes, however, to preserve the option of loading more warheads onto the new Ground-Based Strategic Deterrent, in case of a breakdown in nuclear arms control with Russia. This has been called a warhead upload hedge since the Clinton administration. To load up 400 of the new missiles with three warheads each would require 1200 warheads, which would require more W87-1s and therefore more pits.

No realistic circumstance that would require uploading the US ICBMs has been suggested, however. The Joint Chiefs reportedly informed President Obama that they could cover all essential targets in potential adversary nations with one third fewer warheads than the 1,550 counted warheads that are allowed by New START. Further, Minuteman IIIs were downloaded to one warhead each after the end of the Cold War to make the deterrent relationship with Russia more stable. After the downloading, destroying one US warhead in a first strike would, on average, require more than one Russian warhead.

Beyond those arguments against uploading, many respected defense experts, including former Defense Secretary William Perry, argue that the US should abandon fixed land-based ICBMs altogether, because Strategic Command insists on keeping them in a dangerous launch-on-warning posture.

Little firm information has been made public about the design of the proposed W93 warhead for submarine-launched nuclear missiles. In fact, NNSAs Fiscal Year 2020 Stockpile Stewardship and Management Plan describes the Next Navy Warhead, as not yet an established program of record.

An anonymous senior defense official has offered the reassurance, however, that the W93 would be previously nuclear-tested designs, its not going to require any nuclear testing. This must mean that a previously tested insensitive high explosive primary would be used.

In 1990, in hearings before the Senate Appropriations Committees Subcommittee on Energy and Water, the Energy Departments then Deputy Assistant Secretary of Energy for Military Applications listed all US nuclear warheads with insensitive high explosive, including warheads that had been produced and deployed and some that had been tested but not deployed as a result of the end of the Cold War. The candidate warhead that has been discussed for three decades is the W89, one of the warheads that was tested but not produced. The W89 was to use recycled pits. According to one report, the pits were to be from the W68, a previous-generation SLBM warhead for which thousands of pits were produced during the 1970s. If that option were pursued, and the W68 pits were found to be still functional, no new pit production would be required.

The decision on the second pit production facility can wait. NNSA could announce its decision to move forward on building a pit-production facility in South Carolina as early as September. Based on the above context, this decision should be delayed for a number of reasons:

1. Since the Savannah River Site staff has no experience with pit production, the facility would have to be designed and the staff trained by the Los Alamos group. But the Los Alamos group has not yet demonstrated that that it can design and staff its own pit production facility.2. Within a decade, we should have a new lower limit on the functional lives of the legacy pits. If they will indeed last for at least 150 years, as the Livermore experts concluded, then there will be no need for a large production facility to replace them anytime soon. The Los Alamos facility, if it can be made operational, should be sufficient for some decades.3. The argument for producing additional warheads with insensitive high explosive for the Minuteman III replacement is very weak, and the debate over the need to produce new pits for a warhead to replace the W-76, the most numerous warhead in the US operational stock (about 1,500) cannot be made until NNSA and Defense Department are ready to discuss what pit they would use in the W93.

We can wait for another decade before we decide on whether the United States requires two pit production facilities. Indeed, we can wait for another decade before we decide on whether we need any new pits at all.

Read more:
Why a decision on a second US plutonium-pit-production factory should be delayed - Bulletin of the Atomic Scientists

Recommendation and review posted by Bethany Smith

The number of total unemployment claims filed in the United Statesthroughout the now-months-longCOVID-19 recession just surpassed 44 million.

As restaurants and institutions were forced to shut down or drastically curtail their operations, and the financial repercussions spread to the rest of the economy, many Americans found themselves out of a job and struggling to pay for basic necessities such as rent and food. In April, Feeding America, a network of 200 food banks across the country, reported that demand across its affiliate food banks has increased on average by 40 percent.

And yet, at the same time, reports about mountains of surplus produce and thousands of acres of harvestable crops being plowed under appeared in the news. It was disturbing to see so much food go to waste at a time when the need for it was greatest. Why couldnt farmers simply redirect their surplus to the people who needed it?

The reason is that the food industry, with its complex network of sellers, buyers, processors and supply chains, was experiencing its own significant upheaval. In response, many organizations have worked hard over the past few months to bridge the gap between glut and scarcity. Many of these organizations are businesses or nonprofits that are part of the agricultural industry, while some had no experience with it before. They scrambled to form new partnerships, develop new sales channels and adopt new technologies, sometimes building entirely new supply chains up from scratch, all the while racing against the clock to save as many of the perishable goods that are the product of their industrys labor as possible.

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Food sometimes seems like the most boring of industries. You go into the grocery store and its always there, looking pretty much the same from week to week. There are red, yellow and green bell peppers. There are apples and tomatoes and garlic. Food begins to seem like any other mass-produced product, manufactured for our convenience off an endless assembly line somewhere.

But behind the scenes, there is a mad dash to get the food from farms, livestock producers and fisheries to consumers, with as little loss from damage or spoilage as possible. According to the U.S. Department of Agriculture, an estimated 30 to 40 percent of the total food produced in the U.S. is never consumed, which in 2010 equated to 133 billion pounds or $161 billion. And there are hints that even those numbers could be low, according to a study published last year by Santa Clara University that found a third of edible food grown on farms in California never even makes it off the field.

To prevent spoilage, according to Wired, three fourths of the food in an average meal is funneled through the food supply chain under refrigeration, which is necessary to prevent loss of food as its transported mostly from where its grown in California to where its consumed across the country. Also according to Wired, produce like tomatoes are optimized for how well they hold up in cold storage, rather than for taste.

Thirty to 40 percent of the total food produced in the U.S. is never consumed.

Even so, its a race against the clock. Food loss at a grocery store is a significant part of shrink a retail industry term for the percentage of items that are delivered for sale at a store that dont get sold. At a grocery store, the meat department has the highest level of shrink, followed by the produce department, whose shrink is on average 4.8 percent of sales within the department and contributes to 16 percent of total average store shrink.

Which is all to say that, when COVID-19 hit and restaurants, schools, and other institutions across the country closed down, many farmers suddenly found themselves with no place to send their food and a limited window of time before the crops that they spent months planting, growing and harvesting would all go to waste.

For farmers, the immediate thing that happened when all this shelter in place happened was overnight, all the restaurants, all the K-12 schools and institutions basically stopped ordering any food, said Joe Blunda. For fishers, for many farmers, up to 70 percent of their business evaporated overnight with no warning. Just literally flip a switch, its gone.

Blunda is CEO at Forager, a Maine-based company whose app connects local farms with large buyers, mostly grocery stores. Started in 2017, Forager helps small and local growers tap into larger markets such as grocers, schools and hospitals institutions that normally source food from large farms because it is easier to manage.

If youre a grocery store, for example, you buy a lot of food from what you call mainline or large distributors, who pack big trucks and drive this food from where it is mass-cultivated in warmer areas California, Florida, Mexico and others acrossthe country in cold trucks and deliver to grocers, Blunda said. Its very easy for grocers because distributors aggregate and organize a lot of products into one delivery, but the downside is it really cuts out the local farmer and the local fisher, particularly seafood as well.

According to Blunda, the amount of local food sold in grocery stores and restaurants to consumers is normally between 3 and 5 percent, and local growers often dont reach profitability without developing wholesale channels.

For fishers, for many farmers, up to 70 percent of their business evaporated overnight with no warning. Just literally flip a switch, its gone.

Even for grocery stores that would like to purchase more from local growers, it can be challenging to coordinate, because smaller farms lack the capital to invest in things like support software for logistics and supply chain management.

If youre a grocer and youre buying from a large distributor, youre able to leverage software, and its very efficient to generate orders and to integrate that ordering activity with some of the other systems in your business, Blunda said.

Working with small farms, on the other hand, can take significantly more time to coordinate manually using spreadsheets, emails and texts. And because smaller farms dont grow as much food as large farms, grocers have to work with more of them to get the same amount of inventory.

Forager founder David Stone told Food Industry Executive magazine in an interview that,if a grocer or restaurant wants to source from local food producers, they may have to work with 30, 40, or more independent suppliers.

The classic example we had early on when we started this company was one grocer with six locations and a warehouse, Stone said in an interview with Agriculture.com. On Sunday night, during the height of the season, he would receive 30 to 40 individual emails from farmers with their product lists in them, sometimes as many as 20 or 30 products with prices, and he would print them, put them out on the table, then input them into a Google Sheet and individually email each one of them back.

Foragers platform simplifies these interactions between sellers and buyers by bringing them into one app.

In March, when COVID-19 hit the U.S. hard, the company noticed that buyers on the platform increased the amount they were buying by 180 percent. The company realized that Forager could help with the food waste problem caused by COVID-19 as well. It applied for and received a grant from ReFED, an organization focused on reducing food waste in the U.S.

Local farms are always threatened with profitability risk. Every pound of food that they dont sell becomes a danger for them.

ReFEDs COVID-19 Food Waste Solutions Fund was created to quickly deliver vital funding to organizations that can rapidly scale food waste reduction and hunger relief efforts, according to its website. Angel Veza, who works on ReFEDs capital and innovation team, said the grants were focused on food loss on farms, logistics, distribution and last-mile delivery.

Forager applied for a grant from ReFED so that the company could scale up a pilot partnership program it started this year with a number of gleaning organizations. Gleaning organizations are groups that go to farms following a harvest and collect remaining food that is unharvested for whatever reason whether because an order fell through, or the farmer planted a surplus, or the food looks ugly or imperfect.

Most gleaning organizations are volunteer-based, and the food they glean is donated to food banks, but some organizations are experimenting with making gleaning profitable for farmers.

Local farms are always threatened with profitability risk, Blunda said. Every pound of food that they dont sell becomes a danger for them. So [gleaning organizations] are trying to help farms improve the profitability and sustainability of local food production.

In its pilot, Forager partnered with one gleaning organization to help it find customers for the excess food collected. With the ReFED grant, Forager plans to help farmers across 10 states sell a target of five million pounds of gleaned produce.

Blunda said the idea was to bring the gleaning process into the normal supply chain, and selling to the kinds of customers who can use it for food service deli and prepared food ingredients or even sell directly to consumers.

MORE ON OPERATIONSReal-Time Visibility Software Can Unclog Our Congested Supply Chains

Full Harvest, a San Francisco-based company, is built around a similar concept. The company provides an online marketplace that allows mostly large farms to sell surplus and imperfect produce to food manufacturing companies, which includes customers such as soup companies, press juiceries, baby food and pet food companies across the country.

In May, when Built In spoke to Keely Wachs, head of marketing at Full Harvest, he said the company was trying to connect farmers who had large amounts of surplus due to COVID-19 food service industry closures to food manufacturing companies that make consumer packaged goods.

Weve had some success there, Wachs said. But the truth is that the demand for consumer packaged goods and retail hasnt gone up commensurate with the drop in food service.

Full Harvest has also been starting to connect with organizations such as food banks.

One of the big things weve been trying to figure out is how to get the nonprofit agency types of buyers onto the marketplace, because its kind of a different thing, Wachs said.

But he said that even if farmers with surpluses are able to connect with food banks, there is still an underlying issue. Simply locating surplus crops isnt enough farmers have acres upon acres of produce, which requires significant labor to harvest, package and transport.

The biggest problem is, who pays for it? Wachs said. Typically food banks and those organizations work on donations. The farmers arent going to harvest if theyre not going to get paid some of them will do some donations, but by and large farmers work on very thin margins. So the idea of just going out and harvesting without getting paid is not something that they can do, even if they want to.

Not all of the organizations working to help bridge this gap have worked in the agricultural industry before. One of them, a nonprofit named FarmLink that was founded in March, is run by a group of student volunteers. FarmLink uses donations to pay farmers for their surplus produce and to pay truckers shipping the food to food banks. In May, the nonprofit also received a grant from ReFED to help fund its operations.

We want to kind of slip into the supply chain where its broken, said Jordan Hartzell, a junior at Brown University living in Lewisburg, Pennsylvania, who works on logistics at FarmLink. The nonprofit operates by cold calling farmers to ask about whether they have surplus food and, if so, negotiating a price to buy the surplus from them using the donations FarmLink has raised. The volunteers then find local food banks and ask how much produce they need and are able to take, and finally arrange for the transportation of the food.

One thing that weve really noticed is how difficult it is to connect and reach out to farmers in a scalable way, said Andrew Hojel, a Stanford University student living in Austin, Texas, who helps lead the nonprofits development team. Thats probably one of our biggest bottlenecks, actually getting the farmers to interact with our website, actually just reaching out to the farmers.

A lot of reaching out to farms, finding food banks, and actually engaging with them and figuring out if they need our help, or how we can help, just is very manual.

We were lucky to have a student join us whos really interested in writing scripts to scrape websites, Hartzell said. He did that and found about 1,500 farms and was able to compile a list. That is kind of a new way that we found to research farms, just by scraping a bunch of web pages to find farm names, and contact info, and a gauge of how big the farm is and what produce they have.

But even with a dedicated development team, the nonprofit has found that the work of helping connect farms to food banks still requires a lot of elbow grease.

What weve seen with a lot of these processes is that they really cant be automated easily, Hojel said. Early on we thought that we could drive traffic to our website, with farmers saying, Weve had this surplus, but it definitely is not a simple thing....A lot of reaching out to farms, finding food banks, and actually engaging with them and figuring out if they need our help, or how we can help, just is very manual.

Angel Veza from ReFED echoed this sentiment.

I dont ever think technology is a silver bullet, she said. But I think there are a lot of ways it can help reduce food waste.

Veza said that COVID-19 has highlighted the fragility of our food system, specifically that there can be a breakdown of labor and logistics. While she doesnt believe technology can necessarily fix these problems, she listed a few areas of innovation that could help with efforts to build solutions.

There were some trends pre-coronavirus that may be accelerated and involves technology, like farm sensor technologies to monitor key variables like weather and photosynthesis, drone technology that can help farmers monitor and analyze, and targeted use of nutrients and water use and shelf-life extension I think that theres some opportunities there moving forward beyond just this B2B, B2C technology.

I dont ever think technology is a silver bullet, but I think there are a lot of ways it can help reduce food waste.

For its part, FarmLink is working on ways to build up a volunteer network that can become self-sustaining. The development team is creating an app that engages [volunteers] in the work of FarmLink, and supports them with tasks such as lead generation and making calls to farms and food banks.

Were really looking into ways where we can reduce this manual labor and time-intensive tasks, but at this point we really havent found anything, Hojel said. So now were moving more toward taking advantage of the fact that there are so many people interested in helping with the food waste situation and actually getting action and work from them to help their own communities.

Its not hard to see why this is FarmLinks long-term strategy. The nonprofits current crop of student volunteers feel a passion for the work and its goals despite not knowing much about the industry a few months ago.

Its been really wonderful to meet all of these students who are passionate about the same things, Hartzell said. A lot of us have this running joke that well jump out of class to catch a meeting for FarmLink if we need to.

I had no idea how much food waste was generated, she said. I think if you told me to list a few of the steps in the industrial farming supply chain a month ago, I wouldnt have been able to. Just realizing what I dont know was important for me in this project.

MORE ON AG-TECHThe Robot Revolution (of Crop Picking) Is Here

Read more:
How Agtech Is Limiting Food Waste Amid the Coronavirus Pandemic - Built In

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) announced that new data from its ongoing Phase 1/2 HGB-206 study of investigational LentiGlobin gene therapy for adult and adolescent patients with sickle cell disease (SCD) show a near-complete reduction of serious vaso-occlusive crises (VOCs) and acute chest syndrome (ACS). These data are being presented at the Virtual Edition of the 25th European Hematology Association (EHA25) Annual Congress.

Vaso-occlusive crises (VOCs) are the painful, life-threatening episodes that are the primary clinical manifestation of sickle cell disease. The nearly complete elimination of VOCs that we saw in this study is impressive and demonstrates the potential of LentiGlobin for SCD as a treatment for this serious disease, said David Davidson, M.D., chief medical officer, bluebird bio. These results illustrate the type of outcomes we believe are needed to provide truly meaningful improvements for people living with sickle cell disease. In addition, the improvement of laboratory measures of hemolysis and red cell physiology, with nearly pan-cellular distribution of the anti-sickling HbAT87Q, suggest LentiGlobin for SCD may substantially modify the causative pathophysiology of SCD. We are pleased to have reached a general agreement with the FDA on the clinical data required to support a submission for LentiGlobin for SCD and we plan to seek an accelerated approval. We look forward to working with the entire SCD community to bring forward a disease modifying option for patients.

SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the -globin gene that leads to the production of abnormal sickle hemoglobin (HbS). HbS causes red blood cells to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and unpredictable, painful VOCs. For adults and children living with SCD, this means painful crises and other life altering or life-threatening acute complicationssuch as ACS, stroke and infections. If patients survive the acute complications, vasculopathy and end-organ damage, resulting complications can lead to pulmonary hypertension, renal failure and early death; in the U.S. the median age of death for someone with sickle cell disease is 43 - 46 years.

As a physician treating sickle cell for over 10 years, the excruciating pain crises that my patients suffer from is one of the most challenging and frustrating aspects of this disease, said presenting study author Julie Kanter, M.D., University of Alabama at Birmingham. The promising results of this study, which show patients have an almost complete elimination of VOCs and ACS, suggest LentiGlobin for SCD has real potential to provide a significant impact for people living with sickle cell disease.

LentiGlobin for SCD was designed to add functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once patients have the A-T87Q-globin gene, their red blood cells can produce anti-sickling hemoglobin, HbAT87Q, that decreases the proportion of HbS, with the goal of reducing sickled red blood cells, hemolysis and other complications.

As of March 3, 2020, a total of 37 patients have been treated with LentiGlobin for SCD to-date in the HGB-205 (n=3) and HGB-206 (n=34) clinical studies. The HGB-206 total includes: Group A (n=7), B (n=2) and C (n=25).

HGB-206: Group C Updated Efficacy Results

In Group C of HGB-206, 25 patients were treated with LentiGlobin for SCD and have up to 24.8 months of follow-up (median of 12.1; min.-max.: 2.824.8 months). Results from Group C are as of March 3, 2020 and include efficacy data for 16 patients who had at least a Month 6 visit, and safety data for 18 patients, which includes two patients who were at least six months post-treatment but results from a Month 6 visit are not available.

In 16 patients with six or more months of follow-up, median levels of gene therapy-derived anti-sickling hemoglobin, HbAT87Q, were maintained with HbAT87Q contributing at least 40% of total hemoglobin. At last visit reported, total hemoglobin ranged from 9.6 16.2 g/dL and HbAT87Q levels ranged from 2.7 9.4 g/dL. At Month 6 the production of HbAT87Q was associated with a reduction in the proportion of HbS in total hemoglobin. Patients had a median of 60% HbS. All patients in Group C were able to stop regular blood transfusions and remain off transfusions at three months post-treatment.

There was a 99.5% mean reduction in annualized rate of VOC and ACS among the 14 patients who had at least six months of follow-up and a history of VOCs or ACS, defined as four or more VOC or ACS events in the two years prior to treatment. These 14 patients had a median of eight events in the two years prior to treatment (min.-max.: 4 28 events).

There were no reports of serious VOCs or ACS at up to 24 months post-treatment in patients with at least six months of follow-up (n=18). As previously reported, one non-serious Grade 2 VOC was observed in a patient approximately 3.5 months post-treatment with LentiGlobin for SCD.

In sickle cell disease, red blood cells become sickled and fragile, rupturing more easily than healthy red blood cells. The breakdown of red blood cells is hemolysis and this process occurs normally in the body. However, in sickle cell disease hemolysis happens too quickly due to the fragility of the red blood cells, which results in hemolytic anemia.

Patients treated with LentiGlobin for SCD demonstrated improvement in key markers of hemolysis, which are indicators of the health of red blood cells. Lab results assessing these indicators were available for the majority of the 18 patients with 6 months of follow-up. The medians for reticulocyte counts (n=15), lactate dehydrogenase (LDH) levels (n=13) and total bilirubin (n=16) improved compared to screening and stabilized by Month 6. In patients with Month 24 data (n=5) these values approached the upper limit of normal by Month 24. These results suggest treatment with LentiGlobin for SCD is improving biological markers of sickle cell disease.

Assays were developed by bluebird bio to enable the detection of HbAT87Q and HbS protein in individual red blood cells as well as to assess if HbAT87Q was pancellular, present throughout all of a patients red blood cells. Samples from a subset of patients in Group C were assessed. In nine patients who had at least six months of follow-up, the average proportion of red blood cells positive for HbAT87Q was greater than 70%, and on average more than 85% of red blood cells contained HbAT87Q at 18 months post-treatment, suggesting near-complete pancellularity of HbAT87Q distribution.

HGB-206: Group C Safety Results

As of March 3, 2020, the safety data from all patients in HGB-206 are generally reflective of underlying SCD and the known side effects of hematopoietic stem cell collection and myeloablative conditioning. There were no serious adverse events related to LentiGlobin for SCD, and the non-serious, related adverse events (AEs) were mild-to-moderate in intensity and self-limited.

One patient with a history of frequent pre-treatment VOE, pulmonary and systemic hypertension, venous thrombosis, obesity, sleep apnea and asthma had complete resolution of VOEs following treatment, but suffered sudden death 20 months after treatment with LentiGlobin for SCD. The patients autopsy revealed cardiac enlargement and fibrosis, and concluded the cause of death was cardiovascular, with contributions from SCD and asthma. The treating physician and an independent monitoring committee agreed this death was unlikely related to LentiGlobin for SCD gene therapy.

The presentation is now available on demand on the EHA25 website:

About HGB-206

HGB-206 is an ongoing, Phase 1/2 open-label study designed to evaluate the efficacy and safety of LentiGlobin gene therapy for SCD that includes three treatment cohorts: Groups A (n=7), B (n=2) and C (n=25). A refined manufacturing process that was designed to increase vector copy number (VCN) and improve engraftment potential of gene-modified stem cells was used for Group C. Group C patients also received LentiGlobin for SCD made from HSCs collected from peripheral blood after mobilization with plerixafor, rather than via bone marrow harvest, which was used in Groups A and B of HGB-206.

LentiGlobin for Sickle Cell Disease Regulatory Status

bluebird bio reached general agreement with the U.S. Food and Drug Administration (FDA) that the clinical data package required to support a Biologics Licensing Application (BLA) submission for LentiGlobin for SCD will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. The planned submission will be based on an analysis using complete resolution of severe vaso-occlusive events (VOEs) as the primary endpoint with at least 18 months of follow-up post-treatment with LentiGlobin for SCD. Globin response will be used as a key secondary endpoint.

bluebird bio anticipates additional guidance from the FDA regarding the commercial manufacturing process, including suspension lentiviral vector. bluebird bio announced in a May 11, 2020 press release it plans to seek an accelerated approval and expects to submit the U.S. BLA for SCD in the second half of 2021.

About LentiGlobin for Sickle Cell Disease

LentiGlobin for sickle cell disease is an investigational gene therapy being studied as a potential treatment for SCD. bluebird bios clinical development program for LentiGlobin for SCD includes the ongoing Phase 1/2 HGB-206 study and the ongoing Phase 3 HGB-210 study.

LentiGlobin for SCD received orphan medicinal product designation from the European Commission for the treatment of SCD.

The U.S. FDA granted orphan drug designation, regenerative medicine advanced therapy (RMAT) designation and rare pediatric disease designation for LentiGlobin for SCD.

LentiGlobin for SCD is investigational and has not been approved in any geography.

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of betibeglogene autotemcel for -thalassemia or LentiGlobin for SCD. For more information visit: https://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders, including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using three gene therapy technologies: gene addition; cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash., Durham, N.C., and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

LentiGlobin and bluebird bio are trademarks of bluebird bio, Inc.

bluebird bio Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the companys development and regulatory plans for the LentiGlobin for SCD product candidate, and the companys intentions regarding the timing for providing further updates on the development of the product candidate. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the COVID-19 pandemic and resulting impact on our operations and healthcare systems will affect the execution of our development plans or the conduct of our clinical studies; the risk that even if LentiGlobin for SCD addresses ACS and VOC events, that it may not address progressive organ damage experienced by patients with SCD; the risk that the efficacy and safety results observed in the patients treated in our prior and ongoing clinical trials of LentiGlobin for SCD may not persist or be durable; the risk that the efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated in when treating additional patients in our ongoing or planned clinical trials; the risk that the HGB-206 and HGB-210 clinical studies as currently contemplated may be insufficient to support regulatory submissions or marketing approval in the United States and European Union; the risk that regulatory authorities will require additional information regarding our product candidate, resulting in a delay to our anticipated timelines for regulatory submissions, including our application for marketing approval. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

Excerpt from:
New Data Show Near Elimination of Sickle Cell Disease-Related Vaso-Occlusive Crises and Acute Chest Syndrome in Phase 1/2 Clinical Study of bluebird...

Recommendation and review posted by Bethany Smith

Lately, there has been rising awareness among people regarding the therapeutic potential of stem cells for disease management. This is one of the key factors contributing to growth of the global stem cell therapy market.

Further, identification of new stem cell lines, research and development of genome based cell analysis techniques, and investment inflow for processing and banking of stem cell are some of the significant factors augmenting expansion rate of the global stem cell therapy market.

Meanwhile, limitations associated with traditional organ transplantation such as immunosuppression risk, infection risk, and low acceptance rate of organ by body are few features leading to adoption of stem cell therapy. Moreover, high dependency on organ donors for organ transplantation is paving opportunities for growth of the stem cell therapy.

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Moreover, expanding pipeline and development of drugs for new applications are driving growth of the global stem cells market. Growing research activities focused on augmenting the application array of stem cell will also widen the horizon of stem cell market. Researchers are consistently trying to develop novel methods for creating human stem cell in order to comply with the rising demand for stem cell production to be used for disease management.

Development of Advanced Treatment Method Augmenting Market Growth

Lately, various new studies, development of novel therapies, and research projects have come into light in the global stem cell therapy market. Some of these treatment have been by approved by regulatory bodies, while others are still in pipeline for approval of the treatment.

In March 2017, Belgian based biotech firm TiGenix has announced that its latest development- cardiac cell therapy AlloCSC-01 has reached in its phase I/II successfully. It has shown positive results. Meanwhile, the U.S. FDA has also approved the treatment method. If this therapy is well-accepted among the patients, then approximately 1.9 million AMI patients could be treated using the therapy.

Likewise, another significant development that has been witnessed is development novel stem cell based technology for treatment of multiple sclerosis (MS) and similar concerns associated with nervous system. The treatment is developed by Israel-based Kadimastem Ltd. Also, the Latest development has been granted a patent by reputed regulatory body.

Some of the prominent companies operating in the global stem cell therapy landscape are Anterogen Co. Ltd., RTI Surgical, Osiris Therapeutics Inc., Holostem Terapie Avanzate S.r.l., JCR Pharmaceuticals Co. Ltd., MEDIPOST Co. Ltd., Pharmicell Co. Ltd., and NuVasive Inc.

Some of these firms are following various growth strategies such as mergers and acquisitions, strategic alliances, and collaborations, and product development in order to strengthen their foothold in the global market for stem cell therapy.

Dermatology Segment Holds Prominence in Stem Cell Therapy Market

Stem cell therapy, primarily is a regenerative medicine. It encourages the reparative response of damaged, dysfunctional, or diseases tissue with the help of stem cells and associated derivatives. The treatment method is replacing the conventional transplant methods.

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Stem cell therapy method has wide array of application in the field of nervous system treatment, dermatology, bone marrow transplant, multiple sclerosis, osteoarthritis, hearing loss treatment, cerebral palsy, and heart failure. The method aids patients fight leukemia and similar blood related diseases.

Among all, dermatology segment is leading in the global stem cell therapy market. The segment is substantially contributing to growth of the market. Stem cell therapy reduces the after effects of general treatment for burns such as adhesion, infections, and scars among others.

Meanwhile, rising number of patient suffering from diabetes and increase in trauma surgery cases are anticipated to accelerate the adoption of stem cell therapy in the dermatology segment.

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Stem Cell Therapy Market Grows on Back of Growing Awareness Regarding Regenerative Treatment Methods - TMR Research Blog

Recommendation and review posted by Bethany Smith

The Canine Stem Cell Therapy Market research report enhanced worldwide Coronavirus COVID19 impact analysis on the market size (Value, Production and Consumption), splits the breakdown (Data Status 2014-2020 and 6 Year Forecast From 2020 to 2026), by region, manufacturers, type and End User/application. This Canine Stem Cell Therapy market report covers the worldwide top manufacturers like (VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, Vetbiologics, VetMatrix, Magellan Stem Cells, ANIMAL CELL THERAPIES, Stemcellvet) which including information such as: Capacity, Production, Price, Sales, Revenue, Shipment, Gross, Gross Profit, Import, Export, Interview Record, Business Distribution etc., these data help the consumer know about the Canine Stem Cell Therapy market competitors better. It covers Regional Segment Analysis, Type, Application, Major Manufactures, Canine Stem Cell Therapy Industry Chain Analysis, Competitive Insights and Macroeconomic Analysis.

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Canine Stem Cell Therapy Market report offers comprehensive assessment of 1) Executive Summary, 2) Market Overview, 3) Key Market Trends, 4) Key Success Factors, 5) Canine Stem Cell Therapy Market Demand/Consumption (Value or Size in US$ Mn) Analysis, 6) Canine Stem Cell Therapy Market Background, 7) Canine Stem Cell Therapy industry Analysis & Forecast 20202026 by Type, Application and Region, 8) Canine Stem Cell Therapy Market Structure Analysis, 9) Competition Landscape, 10) Company Share and Company Profiles, 11) Assumptions and Acronyms and, 12) Research Methodology etc.

Scope of Canine Stem Cell Therapy Market:The non-invasive stem cell obtaining procedure, augmented possibility of accomplishing high quality cells, and lower price of therapy coupled with high success rate of positive outcomes have collectively made allogeneic stem cell therapy a preference for veterinary physicians. Moreover, allogeneic stem cell therapy is 100% safe, which further supports its demand on a global level. Pet owners are identified to prefer allogeneic stem cell therapy over autologous therapy, attributed to its relatively lower costs and comparative ease of the entire procedure.

A rapidly multiplying geriatric population; increasing prevalence of chronic ailments such as cancer and cardiac disease; growing awareness among patients; and heavy investments in clinical innovation are just some of the factors that are impacting the performance of the global healthcare industry.

On the basis on the end users/applications,this report focuses on the status and outlook for major applications/end users, shipments, revenue (Million USD), price, and market share and growth rate foreach application.

Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes

On the basis of product type, this report displays the shipments, revenue (Million USD), price, and market share and growth rate of each type.

Allogeneic Stem Cells Autologous Stem cells

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Geographically, the report includes the research on production, consumption, revenue, Canine Stem Cell Therapy market share and growth rate, and forecast (2020-2026) of the following regions:

Important Canine Stem Cell Therapy Market Data Available In This Report:

Strategic Recommendations, Forecast Growth Areasof the Canine Stem Cell Therapy Market.

Challengesfor the New Entrants,TrendsMarketDrivers.

Emerging Opportunities,Competitive Landscape,Revenue Shareof Main Manufacturers.

This Report Discusses the Canine Stem Cell Therapy MarketSummary; MarketScopeGives A BriefOutlineof theCanine Stem Cell Therapy Market.

Key Performing Regions (APAC, EMEA, Americas) Along With Their Major Countries Are Detailed In This Report.

Company Profiles, Product Analysis,Marketing Strategies, Emerging Market Segments and Comprehensive Analysis of Canine Stem Cell Therapy Market.

Canine Stem Cell Therapy Market ShareYear-Over-Year Growthof Key Players in Promising Regions.

What is the (North America, South America, Europe, Africa, Middle East, Asia, China, Japan)production, production value, consumption, consumption value, import and exportof Canine Stem Cell Therapy market?

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Coronavirus threat to global Good Growth Opportunities in Canine Stem Cell Therapy Market - Cole of Duty

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Progenitor Cell Product Market Global and Outlook (2016 2026)

The report published onProgenitor Cell Productis an invaluable foundation of insightful data helpful for the decision-makers to form the business strategies related to R&D investment, sales and growth, key trends, technological advancement, emerging market and more.The COVID-19 outbreak is currently going the world over, this report covers the impact of the corona-virus on leading companies in the Progenitor Cell Product sector. This research report categorizes as the key players in the Progenitor Cell Product market and also gives a comprehensive study of Covid-19 impact analysis of the market by type, application and by regions like (Americas, APAC, and EMEA).

Click Here To Access The Free Sample PDF Report (including COVID19 Impact Analysis, full TOC, Tables and Figures):https://www.syndicatemarketresearch.com/market-analysis/progenitor-cell-product-market.html#sample

The global Progenitor Cell Product market report includes key facts and figures data which helps its users to understand the current scenario of the global market along with anticipated growth. The Progenitor Cell Product market report contains quantitative data such as global sales and revenue (USD Million) market size of different categories and subcategories such as regions, CAGR, market shares, revenue insights of market players, and others. The report also gives qualitative insights into the global Progenitor Cell Product market, which gives the exact outlook of the global as well as country level Progenitor Cell Product market.

Major Companies Profiled in the Global Progenitor Cell Product Market are:NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

The focus of the global Progenitor Cell Product market report is to define, categorized, identify the Progenitor Cell Product market in terms of its parameter and specifications/ segments for example by product, by types, by applications, and by end-users. This study also provides highlights on market trends, market dynamics (drivers, restraints, opportunities, challenges), which are impacting the growth of the Progenitor Cell Product market.

By Type, the Progenitor Cell Product market is segmented into:Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others

By Application, the Progenitor Cell Product market is segmented into:Medical care, Hospital, Laboratory

For Any Query Regarding the Progenitor Cell Product Market Report? Contact Us at:https://www.syndicatemarketresearch.com/inquiry/progenitor-cell-product-market

Progenitor Cell Product Market Regional Analysis

The Regions covered in this study are North America, Europe, Middle East & Africa, Latin America, and the Asia Pacific. It analyzes these regions on the basis of major countries in it. Countries analyzed in the scope of the report are the U.S., Canada, Germany, the UK, France, Spain, Italy, China, India, Japan, South Korea, Southeast Asian countries, Australia, Brazil, Mexico, GCC countries, Egypt, South Africa, and Turkey among others.

Main Highlights and Significant aspects of the Reports:

A comprehensive look at the Progenitor Cell Product Industry Changing business trends in the global Progenitor Cell Product market Historical and forecast size of the Progenitor Cell Product market in terms of Revenue (USD Million) Detailed market bifurcation analysis at a various level such as type, application, end-user, Regions/countries Current industry growth and market trends Player positioning analysis and Competitive Landscape analysis for the Progenitor Cell Product market Key Product presents by Major players and business strategies used Niche and Potential segments (ex. types, applications, and regions/countries) predicted to revealed promising growth Key challenges encountered by operating players in the market space Analysis of major risks linked with the market operations

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Overview:This segment offers an overview of the report to provide an idea regarding the contents and nature of the research report along with a wide synopsis of the global Progenitor Cell Product Market.

Analysis of Leading Players Strategies:Market top players can utilize this analysis to increase the upper hand over their rivals in the market.

Study on Major Market Trends:This segment of the report delivers a broad analysis of the most recent and future market trends.

Forecasts of the Market:The report gives production, consumption, sales, and other market forecasts. Report Buyers will approach exact and approved evaluations of the total market size in terms of value and volume.

Analysis of Regional Growth:This report covered all major regions and countries. The regional analysis will assist market players to formulate strategies specific to target regions, tap into unexplained regional markets, and compare the growth of all regional markets.

Analysis of the Segment:This report provides a reliable and accurate forecast of the market share of important market segments. This analysis can be used by market participants for strategic development so that they can make significant growth in the Progenitor Cell Product market.

The main questions given in the report include:

1.What will be the market size and growth rate in 2026 with COVID-19 Impact Analysis?2.What are the major market trends impacting the growth of the global market with COVID-19 impact analysis?3.Who are the major players operating in the worldwide market?4.What are the important factors driving the worldwide Progenitor Cell Product market?5.What are the challenges to market growth?6.What are the opportunities and threats faced by the vendors in the international market?7.What are the trending factors affecting the market shares of the Americas, APAC, and EMEA?8.What are the major effects of the five forces analysis of the global Progenitor Cell Product market?

Note In order to provide a more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.(*If you have any special requirements, please let us know and we will offer you the report as you want.)

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Global Progenitor Cell Product Market 2020 with Coronavirus (COVID-19) Effect Analysis | likewise Industry is Booming Globally with Key Players ...

Recommendation and review posted by Bethany Smith

For millions of Americans, though, keeping normalcy at bay for such a long time is a luxury they cant afford. People need to hold onto their jobs. Or find new ones. The streets are filling up with Americans who are responding to one national crisisthat of police brutality and systemic racismin the midst of another. And the economy is in cardiac arrest.

Just last week, to address this, the governor of my state announced an accelerated reopening. In the last weeks, there were about 1,500 new coronavirus cases in our region, an increase of 37 percent. In all these headlines, I can see cracks in the walls Ive built around my mom and my partner. How do we bubble people stay safe as the world moves ahead? In some ways people who are immunocompromised have lived their lives in preparation for all of this, Mamjunder told me.

Not long ago, in response to WIRED's Covid-19 coverage, the publication got an email from a woman named Brandy Stephens whod been diagnosed with acute lymphoblastic leukemia in 2014, when she was 26. She and her husband had a 1-year-old daughter. Her treatment put her in the hospital for 165 days, 35 of them on a ventilator. During that time a mere houseplant could have killed me, she wrote. I had multi-organ failure, my bone marrow died, I had pulmonary embolisms, a partially collapsed lung. Then, a stem cell transplant built her a new immune system. In July 2019, at the five-year mark, Stephens was finally able to be reimmunized, against the scary things that babies are immunized for.

Most of the world does not know we exist, she wrote.

I called her to ask about how she did it. I needed to know how to shepherd my mom and partner through a reopened world. I couldn't eat takeout for a year post-transplant. I carry sanitizer, gloves, masks, Lysol with me. She added, My husband is my rock. It has become second nature to have real quirks, to, say, go to family gatherings but not get close to anyone. She knows how to do this. I feel for people who never have had to isolate before, she added, I went through that struggle. (Immunocompromised people have figured out how to protest too.)

We are lucky to live in an area that has kept the overall coronavirus numbers low, yet the steady tick of reminders about potential Covid-19 resurgences haunt me. For everyone in this pandemic, its hard right now to accurately see a future beyond quarantine. Will we return to normal this year? What does normal mean? Something different for all of us, of course.

Last Friday afternoon I was working at Moms house, and I took a break. We were sitting in her living room, on her lovely blue couches. The dog tucked his head under her arm. Mom asked me what I was looking forward to.

The question jolted me. In pre-corona times, I tried to keep things on the calendar to look forward to. But over the past two months I have shut that instinct down.

Now, my mind ricocheted. Restaurants. Could I look forward to eating at our favorite pizza joint? My partners brother: He just added a new floor at the top of the house, a big glorious room with sliding glass doors that open to a porch overlooking the Pacific. He wants to have parties in that big, cheerful space. Will we be there?

Here are the things I hope to put on my calendar someday soon: dinner at our friends house. Driving with Mom for a day at our favorite beach, without worrying about crowds. Those parties at my partners brothers house, in that big, cheerful space. And if need be, flights to a different city if the new treatments we need for my partners cancer arrive, via a trial, somewhere else.

I hope I can put all of those things on the calendar, for the time we have left together.

More From WIRED on Covid-19

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The Country Is Reopening. Im Still on Lockdown - WIRED

Recommendation and review posted by Bethany Smith

Global Exosome Therapeutic Market report is of huge importance when it is about building business strategy by identifying the high growth and attractive market categories. This report assists to design capital investment strategies based on forecasted high potential segments. With this market report, it becomes simple and easy to develop competitive strategy based on competitive landscape. Moreover, potential business partners, acquisition targets and business buyers can be identified by using this Exosome Therapeutic Market research report. To plan for a new product launch and inventory in advance, this business report provides several useful insights.

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Market Analysis and Insights:Global Exosome Therapeutic Market

Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

The major players covered in the Exosome Therapeutic Market report are evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global. Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

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Exosomes are used to transfer RNA, DNA, and proteins to other cells in the body by making alteration in the function of the target cells. Increasing research activities in exosome therapeutic is augmenting the market growth as demand for exosome therapeutic has increased among healthcare professionals.

Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

Global Exosome Therapeutic Market Scope and Market Size

Global exosome therapeutic market is segmented of the basis of type, source, therapy, transporting capacity, application, route of administration and end user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Based on type, the market is segmented into natural exosomes and hybrid exosomes. Natural exosomes are dominating in the market because natural exosomes are used in various biological and pathological processes as well as natural exosomes has many advantages such as good biocompatibility and reduced clearance rate compare than hybrid exosomes.

Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process. The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

Rising demand of exosome therapeutic across the globe as exosome therapeutic is expected to be one of the most prominent therapies for autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases treatment, according to clinical researches exosomes help to processes regulation within the body during treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases. This factor has increased the research activities in exosome therapeutic development around the world for exosome therapeutic. Hence, this factor is leading the clinician and researches to shift towards exosome therapeutic. In the current scenario the exosome therapeutic are highly used in treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases and as anti-aging therapy as it Exosomes has proliferation of fibroblast cells which is significant in maintenance of skin elasticity and strength.

Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. Mesenchymal stem cells are dominating in the market because mesenchymal stem cells (MSCs) are self-renewable, multipotent, easily manageable and customarily stretchy in vitro with exceptional genomic stability. Mesenchymal stem cells have a high capacity for genetic manipulation in vitro and also have good potential to produce. It is widely used in treatment of inflammatory and degenerative disease offspring cells encompassing the transgene after transplantation.

Based on therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. Chemotherapy is dominating in the market because chemotherapy is basically used in treatment of cancer which is major public health issues. The multidrug resistance (MDR) proteins and various tumors associated exosomes such as miRNA and IncRNA are include in in chemotherapy associated resistance.

Based on transporting capacity, the market is segmented into bio macromolecules and small molecules. Bio macromolecules are dominating in the market because bio macromolecules transmit particular biomolecular information and are basically investigated for their delicate properties such as biomarker source and delivery system.

Based on application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. Oncology segment is dominating in the market due to rising incidence of various cancers such as lung cancer, breast cancer, leukemia, skin cancer, lymphoma. As per the National Cancer Institute, in 2018 around 1,735,350 new cases of cancer was diagnosed in the U.S. As per the American Cancer Society Inc in 2019 approximately 268,600 new cases of breast cancer diagnosed in the U.S.

Based on route of administration, the market is segmented into oral and parenteral. Parenteral route is dominating in the market because it provides low drug concentration, free from first fast metabolism, low toxicity as compared to oral route as well as it is suitable in unconscious patients, complicated to swallow drug etc.

The exosome therapeutic market, by end user, is segmented into hospitals, diagnostic centers and research & academic institutes. Hospitals are dominating in the market because hospitals provide better treatment facilities and skilled staff as well as treatment available at affordable cost in government hospitals.

Exosome therapeutic Market Country Level Analysis

The global exosome therapeutic market is analysed and market size information is provided by country by type, source, therapy, transporting capacity, application, route of administration and end user as referenced above.

The countries covered in the exosome therapeutic market report are U.S. and Mexico in North America, Turkey in Europe, South Korea, Australia, Hong Kong in the Asia-Pacific, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua, Uruguay as part of Latin America.

Country Level Analysis, By Type

North America dominates the exosome therapeutic market as the U.S. is leader in exosome therapeutic manufacturing as well as research activities required for exosome therapeutics. At present time Stem Cells Group holding shares around 60.00%. In addition global exosomes therapeutics manufacturers like EXOCOBIO, evox THERAPEUTICS and others are intensifying their efforts in China. The Europe region is expected to grow with the highest growth rate in the forecast period of 2019 to 2026 because of increasing research activities in exosome therapeutic by population.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration

Global exosome therapeutic market also provides you with detailed market analysis for every country growth in pharma industry with exosome therapeutic sales, impact of technological development in exosome therapeutic and changes in regulatory scenarios with their support for the exosome therapeutic market. The data is available for historic period 2010 to 2017.

Competitive Landscape and Exosome Therapeutic Market Share Analysis

Global exosome therapeutic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, concept cars, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to global exosome therapeutic market.

Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.

For instance,

Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for exosome therapeutics through expanded model range.

Customization Available:Global Exosome Therapeutic Market

Data Bridge Market Researchis a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customised to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analysed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Factbook) or can assist you in creating presentations from the data sets available in the report.

Do You Have Any Query Or Specific Requirement? Ask to Our Industry Expert @https://www.databridgemarketresearch.com/inquire-before-buying/?dbmr=global-exosome-therapeutic-market&rp

About Data Bridge Market Research :

Data Bridge Market Researchis a versatile market research and consulting firm with over 500 analysts working in different industries. We have catered more than 40% of the fortune 500 companies globally and have a network of more than 5000+ clientele around the globe. Our coverage of industries include Medical Devices, Pharmaceuticals, Biotechnology, Semiconductors, Machinery, Information and Communication Technology, Automobiles and Automotive, Chemical and Material, Packaging, Food and Beverages, Cosmetics, Specialty Chemicals, Fast Moving Consumer Goods, Robotics, among many others.

Data Bridge adepts in creating satisfied clients who reckon upon our services and rely on our hard work with certitude.We are content with our glorious 99.9 % client satisfying rate.

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Exosome Therapeutic Market 2020 Analysis, Trends, Opportunity, Size And Segment | Leading Players evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE...

Recommendation and review posted by Bethany Smith

Global Exosome Therapeutic Market report is of huge importance when it is about building business strategy by identifying the high growth and attractive market categories. This report assists to design capital investment strategies based on forecasted high potential segments. With this market report, it becomes simple and easy to develop competitive strategy based on competitive landscape. Moreover, potential business partners, acquisition targets and business buyers can be identified by using this Exosome Therapeutic Market research report. To plan for a new product launch and inventory in advance, this business report provides several useful insights.

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Market Analysis and Insights:Global Exosome Therapeutic Market

Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

The major players covered in the Exosome Therapeutic Market report are evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global. Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Get Full TOC, Tables and Figures of Market Report @https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market&rp

Exosomes are used to transfer RNA, DNA, and proteins to other cells in the body by making alteration in the function of the target cells. Increasing research activities in exosome therapeutic is augmenting the market growth as demand for exosome therapeutic has increased among healthcare professionals.

Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

Global Exosome Therapeutic Market Scope and Market Size

Global exosome therapeutic market is segmented of the basis of type, source, therapy, transporting capacity, application, route of administration and end user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Based on type, the market is segmented into natural exosomes and hybrid exosomes. Natural exosomes are dominating in the market because natural exosomes are used in various biological and pathological processes as well as natural exosomes has many advantages such as good biocompatibility and reduced clearance rate compare than hybrid exosomes.

Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process. The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

Rising demand of exosome therapeutic across the globe as exosome therapeutic is expected to be one of the most prominent therapies for autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases treatment, according to clinical researches exosomes help to processes regulation within the body during treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases. This factor has increased the research activities in exosome therapeutic development around the world for exosome therapeutic. Hence, this factor is leading the clinician and researches to shift towards exosome therapeutic. In the current scenario the exosome therapeutic are highly used in treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases and as anti-aging therapy as it Exosomes has proliferation of fibroblast cells which is significant in maintenance of skin elasticity and strength.

Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. Mesenchymal stem cells are dominating in the market because mesenchymal stem cells (MSCs) are self-renewable, multipotent, easily manageable and customarily stretchy in vitro with exceptional genomic stability. Mesenchymal stem cells have a high capacity for genetic manipulation in vitro and also have good potential to produce. It is widely used in treatment of inflammatory and degenerative disease offspring cells encompassing the transgene after transplantation.

Based on therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. Chemotherapy is dominating in the market because chemotherapy is basically used in treatment of cancer which is major public health issues. The multidrug resistance (MDR) proteins and various tumors associated exosomes such as miRNA and IncRNA are include in in chemotherapy associated resistance.

Based on transporting capacity, the market is segmented into bio macromolecules and small molecules. Bio macromolecules are dominating in the market because bio macromolecules transmit particular biomolecular information and are basically investigated for their delicate properties such as biomarker source and delivery system.

Based on application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. Oncology segment is dominating in the market due to rising incidence of various cancers such as lung cancer, breast cancer, leukemia, skin cancer, lymphoma. As per the National Cancer Institute, in 2018 around 1,735,350 new cases of cancer was diagnosed in the U.S. As per the American Cancer Society Inc in 2019 approximately 268,600 new cases of breast cancer diagnosed in the U.S.

Based on route of administration, the market is segmented into oral and parenteral. Parenteral route is dominating in the market because it provides low drug concentration, free from first fast metabolism, low toxicity as compared to oral route as well as it is suitable in unconscious patients, complicated to swallow drug etc.

The exosome therapeutic market, by end user, is segmented into hospitals, diagnostic centers and research & academic institutes. Hospitals are dominating in the market because hospitals provide better treatment facilities and skilled staff as well as treatment available at affordable cost in government hospitals.

Exosome therapeutic Market Country Level Analysis

The global exosome therapeutic market is analysed and market size information is provided by country by type, source, therapy, transporting capacity, application, route of administration and end user as referenced above.

The countries covered in the exosome therapeutic market report are U.S. and Mexico in North America, Turkey in Europe, South Korea, Australia, Hong Kong in the Asia-Pacific, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua, Uruguay as part of Latin America.

Country Level Analysis, By Type

North America dominates the exosome therapeutic market as the U.S. is leader in exosome therapeutic manufacturing as well as research activities required for exosome therapeutics. At present time Stem Cells Group holding shares around 60.00%. In addition global exosomes therapeutics manufacturers like EXOCOBIO, evox THERAPEUTICS and others are intensifying their efforts in China. The Europe region is expected to grow with the highest growth rate in the forecast period of 2019 to 2026 because of increasing research activities in exosome therapeutic by population.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration

Global exosome therapeutic market also provides you with detailed market analysis for every country growth in pharma industry with exosome therapeutic sales, impact of technological development in exosome therapeutic and changes in regulatory scenarios with their support for the exosome therapeutic market. The data is available for historic period 2010 to 2017.

Competitive Landscape and Exosome Therapeutic Market Share Analysis

Global exosome therapeutic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, concept cars, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to global exosome therapeutic market.

Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.

For instance,

Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for exosome therapeutics through expanded model range.

Customization Available:Global Exosome Therapeutic Market

Data Bridge Market Researchis a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customised to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analysed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Factbook) or can assist you in creating presentations from the data sets available in the report.

Do You Have Any Query Or Specific Requirement? Ask to Our Industry Expert @https://www.databridgemarketresearch.com/inquire-before-buying/?dbmr=global-exosome-therapeutic-market&rp

About Data Bridge Market Research :

Data Bridge Market Researchis a versatile market research and consulting firm with over 500 analysts working in different industries. We have catered more than 40% of the fortune 500 companies globally and have a network of more than 5000+ clientele around the globe. Our coverage of industries include Medical Devices, Pharmaceuticals, Biotechnology, Semiconductors, Machinery, Information and Communication Technology, Automobiles and Automotive, Chemical and Material, Packaging, Food and Beverages, Cosmetics, Specialty Chemicals, Fast Moving Consumer Goods, Robotics, among many others.

Data Bridge adepts in creating satisfied clients who reckon upon our services and rely on our hard work with certitude.We are content with our glorious 99.9 % client satisfying rate.

Contact Us :

Data Bridge Market Research

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Exosome Therapeutic Market 2020 to Show Tremendous Growth | Leading Players evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United...

Recommendation and review posted by Bethany Smith

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Skin Toner market.

Trusted Business Insights presents an updated and Latest Study on Skin Toner Market 2019-2026. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Skin Toner market during the forecast period (2019-2029).It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Global Skin Toner Market 2020 (Includes Business Impact of COVID-19)

Global Skin Toner Market, Trends, Industry Analysis, Market Size, and Growth Forecast till 2029 is an upcoming report in the process of preparation by the research and analysis team at Trusted Business Insights. The global skin toner market report is structured to deliver insightful details on the various market trends, industry analysis, growth and potential revenue opportunities, and micro and macro indicators. The report has been generated using exhaustive primary and secondary research efforts. The global skin toner market report includes a market competitive landscape, market revenue (US$) and value share (%), market growth, characteristics, regional breakdowns, trends, and market strategies. The report also delivers a full analysis of competitors and key players. The report offers information on market restraints, limitations, and market scenarios, which can impact market growth. In the report, the market is segmented on the basis of product type, product form, distribution channel, and regions and countries.

Request Covid 19 Impact

Skin Toner: Introduction

Among cosmetics products, skin toner or toner, is usually used on the face, and is considered a product that is designed to cleanse the skin and reduce pore size and appearance. Skin toner can be applied using a piece of cotton (a commonly used method), spraying onto the face, or by applying a toner gauze facial mask. A toner, enhances skin surface and imparts a fresh and smoother texture, and keeps the skin hydrated. Toner is a popular beauty product among women consumers, and use of the product has been increasing in the recent past.

Global Skin Toner Market: Dynamics

Drivers: Revenue growth of the global skin toner market is driven by growing awareness about skincare products and ability of some products to rejuvenate and repair damaged or aging cells and tissue. Taking care of skin and hair health and shifting to a healthy lifestyle is a popularly growing trend among millennial consumers in countries across the globe. Toner can alleviate incidence of acne and oily skin-related issues. A variety of skin toners are available in the market, and some have unique properties. Products have been developed and formulated to suit specific skin-related issues, while others are for general use and application. Consumers with dry skin are recommended to use rosewater-based skin toner for improved skin hydration. A current preference among consumers is rising towards plant stem cell-based skin toners, which contain antioxidants and offer anti-aging benefits.

Many cosmetic product manufacturers are increasing investments on the R&D to develop and formulate more ranges of natural or organic beauty products. Awareness among end-users is increasing regarding benefits associated with use of natural ingredients such as coconut oil, almonds, aloe vera, and others. Consumer preference for natural skin toners is based on ingredients source, and is currently among some of the factors that could influence purchase decision.

By Product Type:

The inorganic segment currently accounts for higher revenue share in the market as market penetration, awareness, and product visibility of organic-based products is relatively low, especially in some developing economies. However, rising concerns regarding potential adverse effects associated with skin creams and lotions that contain chemical or synthetic ingredients and formulations is expected to negatively impact revenue growth of the inorganic segment over the next few years.

By Product Form:

Among the product form segments, the fluid segment is projected to continue to lead in terms of revenue share, as this type of product is easier to apply and more convenient to use.

By Distribution Channel:

Among the distribution channel segments in the global skin toner market report, the conventional stores segment as well as the supermarket segment are expected to account for significantly high revenue growth over the forecast period.

However, revenue from the online channel segment is projected to expand at the fastest CAGR over the forecast period. This high projected growth can be attributed to convenience of shopping anytime-anywhere, and high visibility on e-Commerce platforms, as well as free and prompt home delivery and discount offers available online. Social media platforms and influencers using such channels to influence purchase potential, and a number of beauty bloggers or vloggers providing tips on usage and a broader understanding of toners and features, which makes purchasing beauty products is driving market growth. Online channels provide access to a larger product range, some of which might not be accessible in a conventional store.

By Region

The market in North America is expected to account for significant revenue growth. Followed by markets in Asia Pacific, Europe, and Middle East & Africa respectively.

Analysis by Region: Global Skin Toner Market

North America Market Analysis:

North American market growth is driven significantly by revenue contribution from sales in countries such as the US and Canada.

Europe Market Analysis:

Europe is a major market for skin toner owing to significantly high awareness regarding benefits of skincare. Many premium skin toner brands are France-based, and countries in Europe experience long and cold winters, which are major factors driving demand for cold creams, lotions, and other products designed for cleansing and nourishing the skin.

Asia Pacific Market Analysis

Asia Pacific market is projected to register fastest CAGR over the forecast period, which can be attributed to growing population in countries in the region, and expanding younger potential consumer base in counties in the region. These factors, clubbed with increasing consumer base that is focused on health and wellness, as well as personal appearance resulting in a more streamlined beauty regimen, along with increasing need for beauty and skincare products among consumers is projected to continue to drive market growth. Furthermore, launch of new products in countries in the region is expected to open up new avenues for existing players in the skin toner market in Asia Pacific.

Global Skin Toner Market Segmentation:

Segmentation by Product Type:

OrganicInorganic

Segmentation by Product Form:

FluidsMists

Segmentation by Distribution Channel:

SupermarketsConventional StoresOnline

Quick Read Table of Contents of this Report @ Global Skin Toner Market 2020 (Includes Business Impact of COVID-19)

Trusted Business InsightsShelly ArnoldMedia & Marketing ExecutiveEmail Me For Any ClarificationsConnect on LinkedInClick to follow Trusted Business Insights LinkedIn for Market Data and Updates.US: +1 646 568 9797UK: +44 330 808 0580

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Skin Toner Market 2020: Analysis Of Sales, Overview, Segmentation And Growth Rate To 2027 - 3rd Watch News

Recommendation and review posted by Bethany Smith

According to the Graphical Research new growth forecast report titled North America Genetic Testing Market Size By Test Type, Application, Industry Analysis Report, Regional Outlook, Estimated To Exceed USD 15.0 Billion By 2026. Growing incidences of genetic disorders and cancer will serve to be a key factor for North America genetic testing market growth over the upcoming years. Moreover, technological advancement has been a boon in the industry for early detection and treatment of diseases and disorders. According to the National Institutes of Health (NIH), one in 15,000 children suffer from phenylketonuria every year. The early detection of genetic disorders is helpful and essential for further treatment and hence, the increase in genetic testing demand will upsurge the genetic testing market growth in the forecast period.

Request for a sample of this report @ https://www.graphicalresearch.com/request/1330/sample

Technological advancement such as biochip microarray and chromosomal array will augment the industry growth. The test is easily accessible and adopted by doctors and patients to avoid uncertainty of the disorders and genetic aberrations. The techniques help to detect the chromosomal defects with highlighted parts on glass slide and give proper analysis. Moreover, the information associated with the gene alterations can be indicative to lifestyle changes and early treatments thus, will spur the regional industry size.

However, the anxiety and stress associated with uncertain results may hamper the North America genetic testing industry growth in the forthcoming years.

Predictive testing segment held substantial revenue share in 2019 and is estimated to witness around 9.5% CAGR over the analysis timeframe. Predictive testing involves detection of gene mutations associated with genetic disorders after birth or later in life. Usually, this test type of testing provides insights about hereditary disorders such as cystic fibrosis, hemochromatosis, alpha- and beta-thalassemia, sickle cell anemia and others. The early detection has helped the patient to make quick decision about medical treatment. The procedure helps to reduce genetic disease risk thus will further augment the segmental growth.

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Cardiovascular diseases were valued over USD 680.0 million in 2019. The detection of cardiovascular diseases is important for a patient as it is fatal in nature. The test helps with clinical diagnosis, identifies at risk asymptomatic and pre-symptomatic patients in the family. The hereditary cardiovascular disease includes hypertrophic cardiomyopathy, dilated and glycogen storage cardiomyopathy, arrhythmogenic right ventricular dysplasia, Wolff-Parkinson-white syndrome, long QT syndrome another. The segment growth is attributed to information regarding usage and implantation of cardiac defibrillator, enzyme replacement therapy or heart transplantation if required and thereby will escalate the product demand.

Canada genetic testing market is estimated to experience around 9.0% CAGR during the forecasting years. According to the Canadian Cancer Society, around 220,400 cases of cancer are estimated in Canada in 2019. The country is working on providing reimbursement policies and spreading awareness about genetic testing. The testing would help patients for proper treatment and increasing healthcare expenditure will prove beneficial for the Canada genetic testing industry growth.

Major market players in North America genetic testing market are Acumed LLC, CONMED Corporation, DePuy Synthes, Integra LifeScience Holdings Corporation, and Stryker Corporation, among others. These market players have undertaken strategies such as product improvisations and collaborations and mergers to maintain the market competition. For instance, in March 2017, Myriad Genetics launched the Endo Predict Test in the U.S. This product has helped patients suffering from breast cancer and enhanced companys product portfolio resulting into increased customers and revenue.

North America genetic testing market research report includes in-depth coverage of the industrywith estimates & forecast in terms of revenue in USD million from 2015 to 2026, for the following segments:

North America Genetic Testing Market Share, By Test Type, 2015-2026 (USD Million)

North America Genetic Testing Market Size, By Application, 2015-2026 (USD Million)

Browse key industry insights along with Full TOC @ https://www.graphicalresearch.com/table-of-content/1330/north-america-genetic-testing-market

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About Graphical Research:

Graphical Research is a business research firm that provides industry insights, market forecast and strategic inputs through granular research reports and advisory services. We publish targeted research reports with an aim to address varied customer needs, from market penetration and entry strategies to portfolio management and strategic outlook. We understand that business requirements are unique: our syndicate reports are designed to ensure relevance for industry participants across the value chain. We also provide custom reports that are tailored to the exact needs of the customer, with dedicated analyst support across the purchase lifecycle.

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Excessive Growth Opportunities of 10.8% CAGR Estimated to be Experienced by North America Genetic Testing Market During 2020-2026 - 3rd Watch News

Recommendation and review posted by Bethany Smith

The Preimplantation Genetic Testing Market report focuses on the economic developments and business opportunities across different countries for the forecast period 2020 to 2025. Research also show which countries and regions will perform better in the coming years. The overviews, SWOT analysis and strategies of each vendor in the preimplantation genetic testing market provide understanding about the market forces and how those can be exploited to create future opportunities.

Few of the major competitors currently working in global preimplantation genetic testing market are

Thermo Fisher Scientific, Inc., Agilent Technologies, Inc., PerkinElmer, Inc., CooperSurgical, Inc., Beijing Genomics Institute (BGI), Abbott Laboratories, Natera, Inc., Genea Limited, Rubicon Genomics, Inc. and Oxford Gene Technology

Request sample copy of this report at:https://www.adroitmarketresearch.com/contacts/request-sample/1483

The study predicts the growth of the preimplantation genetic testing Market based on market size, market share, demand, trends and gross sales. It also focuses on the positions of large companies in relation to the competitive landscape and their individual share in the world market. The report segments the industry by product type, application and end use. It shows the latest trends and technological developments in the industry that can influence the industry. The study provides a detailed perspective on the trends observed in the market, the contributing factors, the main players, the key companies and the main areas with growth potential.

The report covers the competitive landscape of the global preimplantation genetic testing market. It states the market state of all the prominent vendors in the market. It is very important for the vendors to provide customers with new and improved product/ services in order to gain their loyalty. The up-to-date, complete product knowledge, end users, industry growth will drive the profitability and revenue. preimplantation genetic testing market report studies the current state of the market to analyze the future opportunities and risks. preimplantation genetic testing market report provides a 360-degree global market state. Potential consumers, market values, and the future scope for the preimplantation genetic testing market are explained thoroughly to the users in this report. The key players of preimplantation genetic testing industry, their product portfolio, market share, industry profiles is studied in this report.

Read complete report description with TOC at:https://www.adroitmarketresearch.com/industry-reports/preimplantation-genetic-testing-market

Global Preimplantation Genetic Testing Market is segmented based by type, application and region.

Based on Type, the market has been segmented into:

by Test Type (Aneuploidy, Structural Chromosomal Abnormalities, Single Gene Disorders, X-linked Disorders, HLA Typing, Gender Identification) and Technology (Next Generation Sequencing, Polymerase Chain Reaction, Fluorescent In-Situ Hybridization, Comparative Genomic Hybridization, Single Nucleotide Polymorphism)

This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. preimplantation genetic testing market Report offers critical information pertaining to the current and future growth of the market. It focuses on technologies, volume, and materials in, and in-depth analysis of the market. The study has a section dedicated for profiling key companies in the market along with the market shares they hold.

The report clarifies the following uncertainties related to the preimplantation genetic testing Market:1. What are the various factors that are likely to impact the growth of the preimplantation genetic testing Market?2. How are market players expanding their footprint in the preimplantation genetic testing Market?3. What is the most notable trend that is currently influencing the dynamics of the preimplantation genetic testing Market?4. Who are the leading players operating in the preimplantation genetic testing Market?5. Which regional market is likely to present a plethora of opportunities for market players in the preimplantation genetic testing Market?

Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe, MEA or Asia Pacific at:https://www.adroitmarketresearch.com/contacts/enquiry-before-buying/1483

About Us :

Adroit Market Research is an India-based business analytics and consulting company incorporated in 2018. Our target audience is a wide range of corporations, manufacturing companies, product/technology development institutions and industry associations that require understanding of a markets size, key trends, participants and future outlook of an industry. We intend to become our clients knowledge partner and provide them with valuable market insights to help create opportunities that increase their revenues. We follow a code- Explore, Learn and Transform. At our core, we are curious people who love to identify and understand industry patterns, create an insightful study around our findings and churn out money-making roadmaps.

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Preimplantation Genetic Testing Market Size, Share, Tools-Applications, Emerging-Trends, 2019 Growth-Projections, Overview, Business-Opportunities,...

Recommendation and review posted by Bethany Smith

Health care stakeholders need to invest in value-based care, innovative care delivery models, advanced digital technologies. XploreMR will help you to know declarative, procedural, contextual, and somatic information about the Canine Stem Cell Therapy Market. It also provides a critical assessment of the performance of emerging and mature markets in a new publication titled Global Market Study on Canine Stem Cell Therapy: Ongoing Clinical Trials and Focus on Advancements to Push Adoption in Veterinary Clinics.

A synopsis of the global canine stem cell therapy market with reference to the global healthcare pharmaceutical industry

Despite the economic and political uncertainty in the recent past, the global healthcare industry has been receiving positive nudges from reformative and technological disruptions in medical devices, pharmaceuticals and biotech, in-vitro diagnostics, and medical imaging. Key markets across the world are facing a massive rise in demand for critical care services that are pushing global healthcare spending levels to unimaginable limits.

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A rapidly multiplying geriatric population; increasing prevalence of chronic ailments such as cancer and cardiac disease; growing awareness among patients; and heavy investments in clinical innovation are just some of the factors that are impacting the performance of the global healthcare industry. Proactive measures such as healthcare cost containment, primary care delivery, innovation in medical procedures (3-D printing, blockchain, and robotic surgery to name a few), safe and effective drug delivery, and well-defined healthcare regulatory compliance models are targeted at placing the sector on a high growth trajectory across key regional markets.

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Research Methodology

XploreMR utilizes a triangulation methodology that is primarily based on experimental techniques such as patient-level data, to obtain precise market estimations and insights on Molecule and Drug Classes, API Formulations and preferred modes of administration. Bottom-up approach is always used to obtain insightful data for the specific country/regions. The country specific data is again analysed to derive data at a global level. This methodology ensures high quality and accuracy of information.

Secondary research is used at the initial phase to identify the age specific disease epidemiology, diagnosis rate and treatment pattern, as per disease indications. Each piece of information is eventually analysed during the entire research project which builds a strong base for the primary research information.

Primary research participants include demand-side users such as key opinion leaders, physicians, surgeons, nursing managers, clinical specialists who provide valuable insights on trends and clinical application of the drugs, key treatment patterns, adoption rate, and compliance rate.

Quantitative and qualitative assessment of basic factors driving demand, economic factors/cycles and growth rates and strategies utilized by key players in the market is analysed in detail while forecasting, in order to project Year-on-Year growth rates. These Y-o-Y growth projections are checked and aligned as per industry/product lifecycle and further utilized to develop market numbers at a holistic level.

On the other hand, we also analyse various companies annual reports, investor presentations, SEC filings, 10k reports and press release operating in this market segment to fetch substantial information about the market size, trends, opportunity, drivers, restraints and to analyse key players and their market shares. Key companies are segmented at Tier level based on their revenues, product portfolio and presence.

Please note that these are the partial steps that are being followed while developing the market size. Besides this, forecasting will be done based on our internal proprietary model which also uses different macro-economic factors such as per capita healthcare expenditure, disposable income, industry based demand driving factors impacting the market and its forecast trends apart from disease related factors.

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Canine Stem Cell Therapy Market to Expand with Significant CAGR - WorldsTrend

Recommendation and review posted by Bethany Smith

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-361 trial evaluating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with advanced or metastatic urothelial carcinoma (bladder cancer) did not meet its pre-specified dual primary endpoints of overall survival (OS) or progression-free survival (PFS), compared with standard of care chemotherapy. In the final analysis of the study, there was an improvement in OS and PFS for patients treated with KEYTRUDA in combination with chemotherapy (cisplatin or carboplatin plus gemcitabine) compared to chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. The monotherapy arm of the study was not formally tested, since superiority was not reached for OS or PFS in the KEYTRUDA combination arm. The safety profile of KEYTRUDA in this trial was consistent with previously reported studies, and no new safety signals were identified. Results will be presented at an upcoming medical meeting and will be discussed with regulatory authorities.

In this study, KEYTRUDA in combination with chemotherapy in previously untreated patients with advanced or metastatic bladder cancer was rigorously tested against an active control of the current standard of care chemotherapy combination regimen, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. While we are disappointed in these study results, KEYTRUDA has been established as an important option in the treatment of metastatic bladder cancer, and we are committed to continuing our research to help more patients with this disease. We are grateful to the patients and investigators for their participation in this study.

KEYTRUDA has three FDA-approved bladder cancer indications across multiple types and stages of bladder cancer. Additionally, Merck has an extensive clinical development program in bladder cancer and is continuing to evaluate KEYTRUDA as monotherapy and in combination with other anti-cancer therapies across several disease settings (i.e., metastatic, muscle invasive bladder cancer, and non-muscle invasive bladder cancer).

About KEYNOTE-361

KEYNOTE-361 (ClinicalTrials.gov, NCT02853305) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA as monotherapy and in combination with chemotherapy versus chemotherapy alone, the current standard of care, for the first-line treatment of advanced or metastatic urothelial carcinoma. The dual primary endpoints are OS and PFS. Secondary endpoints include duration of response, disease control rate, overall response rate and safety. The study enrolled 1,010 patients who were randomized to receive:

About Bladder Cancer

Bladder cancer begins when cells in the urinary bladder start to grow uncontrollably. As more cancer cells develop, they can form a tumor and spread to other areas of the body. Urothelial carcinoma, the most common type of bladder cancer, starts in the urothelial cells that line the inside of the bladder. It is estimated there were more than 549,000 new cases of bladder cancer and nearly 200,000 deaths from the disease globally in 2018. In the United States, it is estimated there will be more than 81,000 new cases of bladder cancer and nearly 18,000 deaths from the disease in 2020. The five-year survival rate for advanced or metastatic bladder cancer (stage IV) is estimated to be approximately 5%.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 3-4) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Read more:
Merck Provides Update on Phase 3 KEYNOTE-361 Trial Evaluating KEYTRUDA (pembrolizumab) as Monotherapy and in Combination with Chemotherapy in Patients...

Recommendation and review posted by Bethany Smith