A new study led by the University of Edinburgh and Queen Mary University of London has identified a protein that plays a crucial role in protecting the bodys blood stem cells from damage during infection, a finding that could lead to new ways to slow down the aging process.

Hematopoietic stem cells (HSCs) are found in bone marrow, and from there they produce other blood and immune cells. When an infection strikes the body, HSCs are known to ramp up production to fight it off but thats raised some questions for scientists in the past. In particular, how do they protect themselves from damage while working overtime?

We know that inflammatory pathways induced by infection force blood stem cells to rapidly produce immune cells to help combat infections, says Kamil Kranc, corresponding author of the study. However, these pathways can eventually exhaust stem cells or cause their premature aging, and it is important to understand how this can be stopped.

In the new study, the researchers identified a protein called YTHDF2 that seems to be responsible for this important job. When an infection arises, the HSCs produce far more immune cells, but at the same time that triggers inflammatory processes that can damage the stem cells. The study found that the YTHDF2 protein regulates genes that control those inflammatory processes, protecting the stem cells from premature aging.

To investigate the role of YTHDF2, the team engineered mice to be deficient in the protein, then administered a chemical that acts like a viral infection. Sure enough, the mices HSCs appeared to suffer chronic inflammation, altering the production of different blood cell types. Interestingly, the blood of these young animals began to resemble that of much older mice.

The new study seems to agree with previous reports that blood transfusions from young animals to older ones can improve the health of the recipient, and even slow the progression of diseases like Alzheimer's. As such, the team says that future work could investigate whether manipulating levels of YTHDF2 may be a potential anti-aging treatment.

The research was published in the Journal of Experimental Medicine.

Source: University of Edinburgh

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Recommendation and review posted by Bethany Smith

Stuart B Goodman,1,2 Masahiro Maruyama1

1Departments of Orthopaedic Surgery, Stanford University, Stanford, CA, USA; 2Departments of Bioengineering, Stanford University, Stanford, CA, USA

Correspondence: Stuart B GoodmanDepartments of Orthopaedic Surgery, Stanford University, 450 Broadway Street, Redwood City, CA 94063, USATel +1-650-721-7662Fax +1-650-721-3470Email goodbone@stanford.edu

Abstract: Osteonecrosis of the epiphyseal and metaphyseal regions of major weight-bearing bones of the extremities is a condition that is associated with local death of bone cells and marrow in the afflicted compartment. Chronic inflammation is a prominent feature of osteonecrosis. If the persistent inflammation is not resolved, this process will result in progressive collapse and subsequent degenerative arthritis. In the pre-collapse stage of osteonecrosis, attempt at joint preservation rather than joint replacement in this younger population with osteonecrosis is a major clinical objective. In this regard, core decompression, with/without local injection of bone marrow aspirate concentrate (BMAC), is an accepted and evidence-based method to help arrest the progression and improve the outcome of early-stage osteonecrosis. However, some patients do not respond favorably to this treatment. Thus, it is prudent to consider strategies to mitigate chronic inflammation concurrent with addressing the deficiencies in osteogenesis and vasculogenesis in order to save the affected joint. Interestingly, the processes of inflammation, osteonecrosis, and bone healing are highly inter-related. Therefore, modulating the biological processes and crosstalk among cells of the innate immune system, the mesenchymal stem cell-osteoblast lineage and others are important to providing the local microenvironment for resolution of inflammation and subsequent repair. This review summarizes the clinical and biologic principles associated with osteonecrosis and provides potential cutting-end strategies for modulating chronic inflammation and facilitating osteogenesis and vasculogenesis using local interventions. Although these studies are still in the preclinical stages, it is hoped that safe, efficacious, and cost-effective interventions will be developed to save the hosts natural joint.

Keywords: chronic inflammation, osteonecrosis, osteogenesis, vasculogenesis, bone healing, inflammation

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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NEW YORK, Nov. 11, 2020 /PRNewswire/ --Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") today announced that it will host a CD33 program update featuring two key opinion leaders (KOLs) today, November 11th at 4:15 PM ET. The event will feature KOLs Dr. Ehab Atallah from the Medical College of Wisconsin, the senior investigator of the Actimab-A CLAG-M combination trial and Dr. Gary Schiller from the University of California Los Angeles Health, the principal investigator for the Actimab-A venetoclax combination trial as well as members of Actinium's management team. Both KOL's will review data that was included in abstracts accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting. They will also provide their perspectives on the treatment landscape and medical need each trial potentially addresses.

Actimab-A AML Combinations Update Call DetailsWebcast link:https://ir.actiniumpharma.com/presentations-webinarsDate: November 11, 2020Time: 4:15 PM ET

Dr. Ehab Atallah, MD, is a Professor of Medicine and Section Head of Hematological Malignancies at the Medical College of Wisconsin Division of Hematology and Oncology, specializing in leukemia and myelodysplastic syndromes at Froedtert Hospital. Dr Atallah, as senior investigator, will review the Phase 1 data from the Actimab-A CLAG-M combination trial in relapsed or refractory acute myeloid leukemia (R/R AML) that demonstrated 100% remission in the third and planned final dose cohort. Further, 83% of patients (10/12) who received 3 or fewer prior lines of treatment achieved CR or CRi. Notably, 70% of CR/CRi patients (7/10) were MRD negative indicating a deep remission with no detectable disease. Dr. Atallah will also discuss the trial data in the context of data available for other treatment options, including recently approved and novel agents in development, in the fit R/R AML population.

Dr. Gary Schiller, MD, is the Director of Bone Marrow/Stem Cell Transplantation and Professor of Hematology-Oncology at UCLA. Dr. Schiller, a well-published clinical investigator in acute and chronic leukemias and other hematologic malignancies, is the principal investigator on the Phase 1/2 clinical trial of Actimab-A and venetoclax. Dr. Schiller will discuss the lack of viable treatment options for R/R AML and the available opportunity for combination regimens such as Actimab-A plus venetoclax. Last week, the company announced that first-in-human data in this combination trial had been accepted for poster presentation at ASH in December. The trial is in the dose escalation phase with proof of concept data expected in 2021.

CD33 Program ASH Abstract Links

Oral Presentation Title: A Phase I Study of Lintuzumab Ac225 in Combination with CLAG-M Chemotherapy in Relapsed/Refractory AMLPublication Number: 165Link: https://ash.confex.com/ash/2020/webprogram/Paper137218.html

Poster Title: Lintuzumab-225Ac in Combination with Venetoclax in Relapsed/Refractory AML: Early Results of a Phase I/II StudyPublication Number: 2875Link: https://ash.confex.com/ash/2020/webprogram/Paper141132.html

About Actinium's CD33 Program

Actinium's CD33 program is evaluating the clinical utility of Actimab-A, an ARC comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225 or Ac-225. CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome, or MDS, as well as patients with multiple myeloma. The CD33 development program is driven by data from over one hundred and twenty-five treated patients, including a Phase 1/2 trial where Actimab-A produced a remission rate as high as 69% as a single agent. This clinical data is shaping a two-pronged approach for the CD33 program, where at low doses the Company is exploring its use for therapeutic purposes in combination with other modalities and at high doses for use for targeted conditioning prior to bone marrow transplant.Actinium currently has multiple clinical trials ongoing including the Phase 1 Actimab-A CLAG-M and Phase 1/2 Actimab-A venetoclax combination trials and is exploring additional CD33 ARC combinations with other therapeutic modalities such as chemotherapy, targeted agents or immunotherapy.

About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. More information on this Phase 3 clinical trial can be found at sierratrial.com. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy and Phase 1/2 anti-HIV stem cell gene therapy with UC Davis. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Contacts:

Investors:Clayton RobertsonActinium Pharmaceuticals, Inc.crobertson@actiniumpharma.com

Hans VitzthumLifeSci Advisors, LLCHans@LifeSciAdvisors.com(617) 430-7578

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Actinium to Host KOL Call on November 11th Featuring Actimab-A AML Combination Trials - Salamanca Press

Recommendation and review posted by Bethany Smith

TAIPEI, Nov. 9, 2020 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") announced today that they have signed an exclusive agreement with GPCR Therapeutics, Inc. ("GPCR"), a leading Korean biotechnology company, for the continued development of Burixafor worldwide and the commercialization of Taigexyn (nemonoxacin) in South Korea.

Burixafor is a highly potent CXCR4 inhibitor currently under clinical development. It can be used as a stem cell mobilizer for hematopoietic stem cell transplantation and a chemosensitizer in hematological and solid tumors. It can also be used for stem cell collection in healthy individuals for personalized regenerative medicine. Taigexyn is a novel safe and effective antibiotic for the treatment of bacterial infections including those caused by drug-resistant bacteria.

Under the terms of the agreement, GPCR Therapeutics will be wholly responsible for the development, registration, and commercialization of Taigexyn in S. Korea and Burixafor worldwide. Apart from upfront fees, TaiGen will receive shares of GPCR Therapeutics as well as future milestone and royalty payments.

GPCR Therapeutics is a world leader in the field of GPCR heteromer science and hasproprietary expertise and technology applicable to the development of this class of anti-cancer targets. CXCR4 antagonism is a well-accepted avenue towards cancer therapy and GPCR Therapeutics is well experienced and possesses the necessary know-how to develop Burixafor in the oncology field.

Dongseung Seen, CEO of GPCR Therapeutics, said, "This collaboration with TaiGen, which is a leading biotech company engaged in innovative molecular-based platforms with strong R&D capabilities, will lead to a long-term strategic and productive partnership. Further, it is our goal that our work together will position us to be a pre-eminent developer of anti-CXCR4 oncology drugs."

Kuo-Lung Huang, Chairman and Chief Executive Officer of Licensor, said, "This agreement and collaboration with GPCR is a tremendous progress in the continued development of Burixafor. Through the collaboration with GPCR Therapeutics, a novel and effective treatment for cancer patients possessing CXCR4 heteromers is on the horizon while a highly effective antibiotic will enter the S. Korea market to address their unmet medical needs in the near future."

About Burixafor

A stem cell mobilizer, Burixafor, is TaiGen's first fully in-house developed product, a First-in-Class drug with an IND under US FDA. With a variety of potential applications in a number of disease indications, if proven effective in clinical trials, Burixafor will be able to address several unmet medical needs. The molecule is a potent and selective chemokine receptor antagonist which can rapidly mobilize stem cells and progenitor cells from the bone marrow into peripheral circulation. Burixafor also has potential application in chemosensitization treatment of leukemia patients, delaying relapse after chemotherapy.

About Taigexyn

Taigexyn is a novel non-fluorinated quinolone available in both oral and intravenous formulations. The oral formulation of Taigexyn have received market approval in Taiwan and mainland China shown activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumonia. TaiGen partnered with Zhejiang Medicaine Co., Holding Distribution, R-Pharm of Russia, Productos Cientficos S.A. de C.V., Luminarie Canada Inc. and GPCR Therapeutics, Inc. in 36 countries worldwide. In addition to the oral formulation, TaiGen granted NDA approval for intravenous formulation in Taiwan and is going to obtain the market approval in mainland China.

About GPCR Therapeutics, Inc.

Based in Seoul, S. Korea, GPCR Therapeutics is a biopharmaceutical company developing drugs based on the novel science of GPCR (G Protein-Coupled Receptor) heteromers. GPCR Therapeutics is specifically focused on the development of cancer therapeutics with a precision oncology approach.

About TaiGen Biotechnology

TaiGen Biotechnology is a leading research-based and market-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to Taigexyn and Burixafor, TaiGen has two other in-house discovered NCEs: TG-1000, a novel pan-influenza antiviral effective against influenza-A, influenza-B, avian flu H7N7, and Tamiflu-resistant viruses, and Furaprevir, a HCV protease inhibitor for treatment of chronic hepatitis infection. TG-1000 is currently in Phase 1 clinical study in China and is granted IND approval by FDA in the U.S., and Furaprevir is currently in Phase 3 clinical development.

SOURCE TaiGen

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TaiGen Partners with GPCR to develop Burixafor & Taigexyn(R) - PRNewswire

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Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205

About Regenerative Medicine Advanced Therapy (RMAT) DesignationEstablished under the 21st Century Cures Act, the RMAT designation was established to facilitate development and expedite review of cell therapies and regenerative medicines intended to treat serious or life-threatening diseases or conditions. Advantages include the benefits of the FDA's Fast Track and Breakthrough Therapy Designation programs, such as early interactions with the FDA to discuss potential surrogate or intermediate endpoints to support accelerated approval.

About HDT-AHCT High-dose therapy and autologous hematopoietic cell transplantation (HDT-AHCT) is considered a standard-of-care therapy for patients with aggressive systemic Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).Although efficacious and considered a potential cure, HDT-AHCT is associated with severe regimen-related toxicities (SRRT) that increase patient morbidity and risk for mortality, especially in the aging population. Effective prevention of SRRT may lead to more patients being eligible for a potential cure through HDT and stem cell transplantation.

About SRRT Consequences of Diffuse Injury to the Organ Vascular NichesThe human body is capable of renewing, healing and restoring organs.For example, the human oral-GI tract renews its lining every 3 to 7 days. Both the organ renewal and healing processes are dependent on organ stem cell vascular niches made up of stem cells, endothelial cells (cells that line blood vessels) and supportive cells.When tissues are injured, the vascular niche endothelial cells direct the stem cells, via angiocrine factor expression, to repair and restore the damaged tissue. This restorative capacity is most active during childhood and youth but starts to diminish with increasing age.HDT provided to eradicate cancer cells also cause diffuse, collateral damage to vascular niches of multiple healthy organs. In particular, the organs with the highest cell turnover (ones with most active vascular niches) are severely affected.Specifically, the oral-GI tract, dependent on constant renewal of its mucosal lining, starts to break down upon vascular niche injury.The mucosal breakdown can cause severe nausea, vomiting and diarrhea. In addition, the bacteria in the gut may escape into the circulation, resulting in patients becoming ill with endotoxemia, bacteremia or potentially lethal sepsis.HDT-related vascular niche damage can also occur in other organs resulting in severe or life-threatening complications involving the lung, heart, kidney, or the liver.Collectively, these complications are known as severe regimen-related toxicities or SRRT.SRRT can occur as frequently as 50% in lymphoma HDT-AHCT patients, with increased rate and severity in older patients.

About AB205AB-205 is a first-in-class engineered cell therapy consisting of proprietary 'universal' E-CEL (human engineered cord endothelial) cells.The AB-205 cells are intravenously administered after the completion of HDT on the same day as when the patient's own (autologous) blood stem cells are infused. AB-205 acts promptly to repair injured vascular niches of organs damaged by HDT.By repairing the vascular niches, AB-205 restores the natural process of tissue renewal, vital for organs such as oral-GI tract and the bone marrow. Successful and prompt organ restoration can prevent or reduce SRRT, an outcome that is beneficial to quality of life and cost reductive to the healthcare system.

About CIRMThe California Institute for Regenerative Medicine (CIRM) was established in November, 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure provided $3 billion in funding for California universities and research institutions.With over 300 active stem cell programs in their portfolio, CIRM is the world's largest institution dedicated to stem cell research. For more information, visit http://www.cirm.ca.gov.

About Angiocrine Bioscience Inc.Angiocrine Bioscience is a clinical-stage biotechnology company developing a new and unique approach to treating serious medical conditions associated with the loss of the natural healing and regenerative capacity of the body.Based on its novel and proprietary E-CEL platform, Angiocrine is developing multiple therapies to address unmet medical needs in hematologic, musculoskeletal, gastrointestinal, soft-tissue, and degenerative/aging-related diseases.A Phase 3 registration trial is being planned for the intravenous formulation of AB-205 for the prevention of severe complications in lymphoma patients undergoing curative HDT-AHCT.This AB-205 indication is covered by the Orphan Drug Designation recently granted by the US FDA.In addition, Angiocrine is conducting clinical trials of local AB-205 injections for the treatment of: (1) rotator cuff tear in conjunction with arthroscopic repair; and, (2) non-healing perianal fistulas in post-radiation cancer patients.

For additional information, please contact:

Angiocrine Bioscience, Inc.John R. Jaskowiak(877) 784-8496[emailprotected]

SOURCE Angiocrine Bioscience, Inc.

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Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL Cell Therapy) to...

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ALBANY, N.Y., Nov. 11, 2020 /PRNewswire/ --Transparency Market Research has now published a new research report that offers a detailed information about the global alpha mannosidosis market. The research report tries to offer meaningful and actionable insights about the key segments, prominent growth drivers, restraining factors, geographical outlook, and the current situation of the vendor landscape of the global market.

According the research report, the global alpha mannosidosis market was initially valued at US$7.6 Mn in 2018. The research report projects the market to grow at a strong CAGR of 9.9% over the course of the given forecast period ranging from 2019 to 2027. Given the rate of growth, the market is expected to reach a valuation worth US$18.7 Mn by 2027.

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Global Alpha Mannosidosis Market Overview

Explore a report with detailed research, incisive insights, and in-depth country levels estimations. Gain business intelligence on global Alpha Mannosidosis Market (Treatment - Bone Marrow Transplant (BMT) and Enzyme Replacement Therapy (ERT); Indication - Type I, Type II and Type III; End Users - Hospitals and Specialty Clinics) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2019 2027 at https://www.transparencymarketresearch.com/report-toc/2501

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Analyze Alpha Mannosidosis Marketgrowth in 30+ countries including US, Canada, Germany, United Kingdom, France, Italy, Russia, Poland, Benelux, Nordic, China, Japan, India, and South Korea. Request a sampleof the study

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Global Alpha Mannosidosis Competitive Landscape

The global alpha mannosidosis market presently has a single company that markets its product. Zymenex is the industry leader in the global market and has been concentrating on research and development activities to produce more effective therapeutics. The competitive landscape of the global alpha mannosidosis is projected to expand in coming years of the forecast period as other pharma companies with new drugs in pipeline get their approvals.

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Alcoholic Hepatitis Therapeutics Market: Research and development activities have revealed that modification of gut microbiota and products related to it, including nutritional intervention, increasing steroid sensitivity, lipopolysaccharide, immune modulation, and epigenetic modification of liver damage caused by alcohol are some of the groundbreaking avenues in the alcoholic hepatitis therapeutics market that are expected to offer tremendous promise during the forecast period.

Anthelmintic Drugs Market: Companies in the anthelmintic drugs market are increasing their research efforts to study the biologically active substances of medicinal plants that possess drug-like properties and hold promising potentials for the treatment of intestinal parasitic nematodes in human as well as animals. As such, medicinal plant-derived drugs, such as artemether, tiopropium and galantamine are generating revenue streams for pharmaceutical companies.

Hydrocortisone Market: Companies in the hydrocortisone market are introducing medicines that do not require a prescription. For instance, in May 2019, Aflofarm a supplier of Over the Counter drugs (OTC) and medical devices, announced the launch of Maxicortan, a medicine with double dose of hydrocortisone that can be applied locally on skin inflammations and caters to individuals with atopic dermatitis.

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The latest report on Regenerative Medicine market collated by Market Study Report, LLC, delivers facts and numbers regarding the market size, geographical landscape and profit forecast of the Regenerative Medicine market. In addition, the report focuses on major obstacles and the latest growth plans adopted by leading companies in this business.

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The Regenerative Medicine Market is anticipated to reach over USD 79.23 billion by 2026 according to a new research. In 2017, the cell therapy dominated the global Regenerative Medicine market, in terms of revenue. North America is expected to be the leading contributor to the global market revenue in 2017.

The regenerative medicine market is primarily driven by the increasing number of individuals suffering from cancer, rising need to monitor and treating these chronic diseases in the limited time. Furthermore, stringent government policies, proper reimbursement policies, and increasing government healthcare expenditure for developing healthcare infrastructure to also boost the market growth in coming years. Also, rising number of organ transplantation, and increasing number of products in pipeline that are waiting for approval create major opportunity for the regenerative medicines in the coming years. However, some of the ethical and religious concerns for the use of stem cells, and lack of proper regulatory for the approval of various drugs would impede the market growth during the forecast period.

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North America generated the highest revenue in the Regenerative Medicine market in 2017, and is expected to be the leading region globally during the forecast period. Increasing number of patients suffering from chronic diseases, improved healthcare infrastructure and health facilities, accessibility of healthcare facilities, are the primary factors driving the market growth in this region. While, Asia Pacific to be the fastest growing region in the coming years. The growth in this region is majorly attributed to the developing healthcare infrastructure of the countries like India, & China, and rising awareness for the use of regenerative medicines as an effective treatment option for chronic diseases.

Regenerative medicine is a branch of medicine that regrows, and repairs the damaged cells in the human body. These medicines include the use of stem cells, tissue engineering, that further helps in developing new organ that function smoothly. These medicines have the caliber of developing an entire organ as these cells are multipotent. The cells are majorly isolated from bone marrow, and umbilical cord blood.

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The key players operating in the Regenerative Medicine market include Organogenesis Inc., Vericel Corporation, Osiris Therapeutics, Inc., Stryker Corporation, and NuVasive, Inc., Medtronic Plc., Acelity, Cook Biotech Inc., Integra LifeSciences, and C.R. Bard. These companies launch new products and collaborate with other market leaders to innovate and launch new products to meet the increasing needs and requirements of consumers.

Regenerative Medicine Market share byMajor regions included:

United StatesNorth AmericaAsia PacificEuropeMiddle East & Africa

Table of Contents

1. Overview and Scope1.1. Research goal & scope1.2. Research assumptions1.3. Research Methodology1.3.1. Primary data sources1.3.2. Secondary data sources1.4. Key take-away1.5. Stakeholders2. Executive Summary2.1. Market Definition2.2. Market Segmentation3. Regenerative Medicine Market Insights3.1. Regenerative Medicine Industry snapshot3.2. Regenerative Medicine Ecosystem analysis3.3. Regenerative Medicine Market Dynamics3.3.1. Regenerative Medicine Market Forces3.3.1.1. Regenerative Medicine Market Driver Analysis3.3.1.2. Regenerative Medicine Market Restraint/Challenges analysis3.3.1.3. Regenerative Medicine Market Opportunity Analysis3.4. Industry analysis Porters five force3.4.1. Bargaining power of supplier3.4.2. Bargaining power of buyer3.4.3. Threat of substitute3.4.4. Threat of new entrant3.4.5. Degree of competition3.5. Regenerative Medicine Market PEST Analysis3.6. Regenerative Medicine Market Value Chain Analysis3.7. Regenerative Medicine Industry Trends3.8. Competitive Ranking Analysis4. Regenerative Medicine Market Size and Forecast by Therapy Type, 2018-20264.1. Key Findings4.2. Tissue engineering4.3. Cell Therapy4.4. Immunotherapy4.5. Gene Therapy5. Regenerative Medicine Market Size and Forecast by Product Type, 2018-20265.1. Key Findings5.2. Acellular Products5.3. Cellular Products

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Merck Announces KEYNOTE-598 Trial Evaluating KEYTRUDA (pembrolizumab) in Combination With Ipilimumab Versus KEYTRUDA Monotherapy in Certain Patients With Metastatic Non-Small Cell Lung Cancer To Stop for Futility and Patients to Discontinue Ipilimumab

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that it will be stopping KEYNOTE-598, a Phase 3 trial investigating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with ipilimumab (Yervoy ), compared with KEYTRUDA monotherapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] 50%) with no EGFR or ALK genomic tumor aberrations. Merck is discontinuing the study following the recommendation of an independent Data Monitoring Committee (DMC), which determined the benefit/risk profile of the combination did not support continuing the trial. At an interim analysis, the combination of KEYTRUDA and ipilimumab showed no incremental benefit in overall survival (OS) or progression-free survival (PFS), the studys dual primary endpoints, compared with KEYTRUDA alone and crossed futility boundaries. No new safety signals for KEYTRUDA monotherapy were observed, however the combination of KEYTRUDA and ipilimumab was associated with a higher incidence of grade 3-5 adverse events (AEs), serious AEs, and AEs leading to discontinuation or death, compared with KEYTRUDA monotherapy. Merck will inform study investigators of the recommendation from the DMC and the DMC is advising that patients in the study discontinue treatment with ipilimumab/placebo. Data from this study will be submitted for presentation at an upcoming scientific congress and communicated to regulatory agencies.

We conducted KEYNOTE-598 in order to explicitly explore whether combining our anti-PD-1 therapy, KEYTRUDA, with ipilimumab provided additional benefits beyond treatment with KEYTRUDA alone in the metastatic non-small cell lung cancer setting, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity. KEYTRUDA monotherapy remains a standard of care for the treatment of certain patients with metastatic non-small cell lung cancer whose tumors express PD-L1.

While the combination of an anti-PD-1 therapy plus ipilimumab has been approved in certain indications, studies supporting these approvals have, for the most part, not compared the combination directly with anti-PD-1 monotherapy. Bristol Myers Squibb has reported topline results of CheckMate-915, a Phase 3 study in adjuvant melanoma that directly compared treatment with ipilimumab in combination with an anti-PD-1 therapy versus the anti-PD-1 therapy alone. In two separate news releases issued over the last year, the company announced the study did not meet its co-primary endpoints in the all-comer population or in patients whose tumors expressed PD-L1

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies with KEYTRUDA in combination with other treatments and as monotherapy. The lung program is evaluating KEYTRUDA across all stages of disease and lines of therapy in over 200 trials with more than 10,000 patients.

About KEYNOTE-598

KEYNOTE-598 (ClinicalTrials.gov, NCT03302234 ) is a randomized, double-blind, Phase 3 trial investigating KEYTRUDA in combination with ipilimumab compared to KEYTRUDA monotherapy for the first-line treatment of patients with metastatic NSCLC whose tumors express PDL1 (TPS 50%) with no EGFR or ALK genomic tumor aberrations. The dual primary endpoints are OS and PFS. Secondary endpoints include objective response rate, duration of response and safety. The study enrolled 568 patients who were randomized (1:1) to receive:

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10% to 15% of all lung cancers. Before 2014, the five-year survival rate for patients diagnosed in the U.S. with NSCLC and SCLC was estimated to be 5% and 6%, respectively.

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 patients 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 patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

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. 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 or Mismatch Repair Deficient 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.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

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).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 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 TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

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. Pneumonitis occurred in 8% (31/389) of patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% 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 (

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 (

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 (

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 (

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 post-marketing 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)

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risk of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT.

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-204, KEYTRUDA was discontinued due to adverse reactions in 14% of 148 patients with cHL. Serious adverse reactions occurred in 30% of patients; those 1% included pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis. Three patients died from causes other than disease progression. The most common adverse reactions (20%) were upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), and pyrexia, fatigue, and cough (20% each).

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Merck Announces KEYNOTE-598 Trial Evaluating KEYTRUDA in Combination With Ipilimumab Versus KEYTRUDA Monotherapy in Certain Patients With Metastatic...

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A new study out from The Lancet found that 20 percent of COVID-19 patients are diagnosed with a psychiatric disorder within 90 days after the COVID diagnosis. New research on the virus also covers hospital readmissions, melatonin, testing and more.

The Hill:One In Five Coronavirus Patients Develop Mental Illness Within 90 DaysNew research suggests that people who have survived COVID-19 infections are at a greater risk of developing mental illness.This data, published in The Lancet Psychiatry Journal, indicates that 20 percent of observed COVID-19 patients are diagnosed with a psychiatric disorder such as anxiety, depression, or insomnia within 90 days after being diagnosed. (Kelley, 11/10)

Fox News:9% Of Hospitalized Coronavirus Patients Readmitted Within 2 Months Of Discharge: CDC ReportA report released by the Centers for Disease Control and Prevention (CDC) that looked at hospitalized coronavirus patients found that up to 9% were readmitted within two months of discharge. The likelihood of readmission increased for patients over age 65, those with chronic conditions, those who were discharged to a nursing facility or home health care, and those who had been hospitalized within three months prior to a coronavirus-related hospitalization. (Hein, 11/10)

In other COVID science and research news

Fox News:Melatonin Eyed As Possible Coronavirus Treatment, Study SuggestsMelatonin could possibly have more use than just aiding in a good nights sleep. A new study from the Cleveland Clinic suggests the hormone could be a possible treatment option for those infected with thenovel coronavirus. In an analysis of patient data from the Cleveland Clinic's COVID-19 registry, researchers found that melatonin, a hormone that regulates the bodys sleep-wake cycle, was associated with a nearly 30% reduced likelihood of testing positive for SARS-CoV-2 after adjusting for age, race, smoking history and various disease comorbidities, according to a news release accompanying the study published in the journal PLOS Biology.(Farber, 11/10)

CIDRAP:Preemie Tests Negative After Drinking COVID-19Infected Breast MilkA preterm baby girl delivered via emergency cesarean delivery at 32 weeks remained healthy despite drinking SARS-CoV-2infected breast milk from her mother, a case report today in Pediatrics notes. The infant was born at 1.6 kilograms (3 pounds, 9 ounces). During her first 3 days of life, she was largely on noninvasive mechanical ventilation and given donor human or expressed breast milk. The mother occasionally visited the neonatal intensive care unit (NICU) wearing a facemask and gown. (11/10)

The New York Times:New Type Of Test May Better Discern Immunity To The CoronavirusA new type of test can detect a persons immune response to the coronavirus better than a widely used antibody test, according to research released on Tuesday. The test, if authorized by the Food and Drug Administration, would be the first commercial product to detect the response of a T cell a type of immune cell to the virus. Antibodies have dominated the conversation on immunity since the start of the pandemic, but scientists believe that T cells may be just as important in preventing reinfection. (Mandavilli, 11/10)

The New York Times:Covid-19 Threatens People With Intellectual And Developmental ChallengesPeople with intellectual disabilities and developmental disorders are three times more likely to die if they have Covid-19, the illness caused by the coronavirus, compared with others with the diagnosis, according to a large analysis of insurance claims data. The finding raises complex questions about how to allocate new vaccines as they become available in limited supplies. The drug maker Pfizer announced this week that its experimental vaccine is performing well in clinical trials. (Rabin, 11/10)

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Mental Illness Appears To Be Yet Another COVID Side Effect - Kaiser Health News

Recommendation and review posted by Bethany Smith

Up until now, remdesivir is the only approved drug for COVID-19 treatment and favipiravir has received emergency use authorisation. Many other drugs are in various stages of research. As the number of fresh cases rises again in several parts of the world, scientists continue to work towards finding more preexisting and preapproved drugs to treat and manage the coronavirus infection.

Latest in this series, a group of researchers at the Cleveland Clinic claim that melatonin, the hormone that helps regulate the sleep-wake cycle in humans, may be effective in the management of COVID-19 .

The findings of their study are published in the peer-reviewed journal PLOS Biology.

The study

For the research, the scientists studied the genes and proteins of SARS-CoV-2, the causative agent of COVID-19 , using an artificial intelligence system developed by Lerner Research Institute.

They also identified clinical records from patients at the Cleveland clinic to check for similarities in host genes and proteins between COVID-19 and other diseases including autoimmune diseases, cancer, pulmonary, and neurological and metabolic diseases. The closer the genes, the similar the pathology of the two diseases.

Additionally, the researchers listed about 3,000 FDA approved drugs for their potential usein SARS-CoV-2 treatment.

The findings

Here are some of the findings of the study:

The authors of the study indicated that any medicines used for the treatment of the above conditions can also be used to manage COVID-19 . Out of the 3,000 drugs studied, they found 34 drug candidates could potentially treat the condition, melatonin being the chief candidate amongst them.

Melatonin use was found to be associated with reduced pulmonary inflammation due to a reduction in the levels of certain cytokines and an increase in the levels of anti-inflammatory cytokines.

Clinical registries from Cleveland Clinic also showed that regular use of melatonin was associated with a 30percent lesser chance of testing positive for COVID-19 even after adjusting for age, smoking history, race, and the presence of comorbidities.

However, the authors pointed out that this does not mean you start taking melatonin without consulting your doctor.

Explaining the importance of the findings, Dr Cheng, lead author of the study said in a news release by the Cleveland Clinic, Our study provides a powerful, integrative network medicine strategy to predict disease manifestations associated with COVID-19 and facilitate the search for an effective treatment.

However, the authors added that large-scale observational studies and randomized controlled trials are still needed to confirm the findings of the study.

For more information, read our article on COVID-19.

Health articles in Firstpost are written by myUpchar.com, Indias first and biggest resource for verified medical information. At myUpchar, researchers and journalists work with doctors to bring you information on all things health.

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COVID-19 treatment: Melatonin hormone that regulates..p-wake cycle may prove effective in managing infection - Firstpost

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Naomi West keeps her medication in a navy blue briefcase in her room. She says its where she keeps all of the most important items in her life things like her research notes for her physics PhD at Rice University.

West started gender-affirming hormone therapy just over a year ago at the Planned Parenthood clinic in Houston. But earlier this spring, she left Houston to save money. Funding for her PhD dried up due to the pandemic. Luckily, it was right when office visits at her clinic went virtual.

Being 200 miles away, [telehealth] has been incredibly convenient, West said. Rather than going to Houston for just a quick discussion.

Early in the pandemic, many providers, including Planned Parenthood, scrambled to find a way to still provide health care. The stay-at-home order and new social distancing guidelines has pushed telehealth into the mainstream. And for transgender patients who often face a lack of access or discrimination, that can provide both an added sense of safety and flexibility.

West moved in with her sister in Austin, a city where she could have found a new provider but that would have meant an interruption in her care. Dr. Bhavik Kumar, medical director of primary and trans care at Planned Parenthood Gulf Coast, said that can be really tough for patients both physically and mentally.

When youve already made that connection and you trust your provider, being able to hold on to that can be so meaningful for folks, especially those already marginalized within healthcare, said Dr. Kumar.

Telehealth at Planned Parenthood took off this year, replacing almost one-third of all office appointments.

For check ups, patients can connect with their providers through video chat. In-person care like blood work or vital signs can be done at a local lab much closer to where the patient lives.

As a result, the clinics have started seeing patients from hundreds of miles away, including rural areas of Texas like Lufkin, Iola and Franklin, as well as out-of-state patients in Alabama and Mississippi.

We are definitely seeing folks from different parts of the state and further away than we did before, said Dr. Kumar.

One reason is because hormone therapy is hard to find in most Texas towns, especially providers trained in transgender competency.

As a transgender person, you have so many questions and uncertainties for your safety, said Evan Mahony, a patient advocate at The Kind Clinic in San Antonio and Austin. Are there going to be gender neutral restrooms at this doctors office? What if I feel afraid that somebody is going to confront me in the parking lot?

According to a 2017 poll by NPR, Harvard and the Robert Wood Johnson Foundation, 20% of transgender people surveyed said they have avoided seeking medical care for fear theyd be discriminated against.

Mahony says that telehealth can be a lot less risky for trans folks.

If this encounter doesnt go well, all I have to do is hang up, Mahony said. Im not going to have to strategize how Im going to leave a place that makes me feel physically unsafe.

Although the pandemic has improved access through telehealth, the economic impacts of COVID-19 on the trans community have added major barriers.

Job losses, especially in the service industry, has made it even harder to afford care that is expensive and not always covered by insurance.

In the spring, like many procedures deemed non-essential, gender affirming surgeries were postponed and some indefinitely canceled.

I know a lot of people in the community who had to cancel the surgery because they had lost income, Mahony said.

Even though Austin has many health care resources, Naomi West said she still travels to Houston every three months to get bloodwork done at her provider. In her experience, freestanding labs are more costly.

Even with the cost of gas, its significantly cheaper than it is to go to any other place, she said.

But West has no doubt that the drive is worth it. She said the therapy has helped her overcome feelings surrounding gender dysphoria.

What hasnt the medication done for me? said West. I feel like a completely different person.

From Houston Public Media

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COVID-19 Forced Clinics To Adopt Telehealth. That Helped Some Transgender Patients Access Care. - KERA News

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Feminizing hormone therapy is a common way for transfeminine or gender non-binary individuals to achieve traditionally female characteristics and feel more comfortable in their own bodies. Here's how it works, what you can expect from the procedure, and important health risks to know.

Feminizing hormone therapy can involve taking estrogen and anti-androgen hormones. An anti-androgen is any drug that blocks the production of male sex hormones, mainly testosterone.

"I usually talk to most of my patients that, in general, hormone therapy is not quick to act. It's a process and it does take a couple of years," Iyengar says.

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To develop the right individualized treatment plan, you should talk with your doctor about what you'd like to gain from feminizing hormone therapy and your preferred timetable, as you can adjust your dosage accordingly.

"Every person is unique based on their own health factors and their family history," says Amy Weimer, MD, a primary care physician with a clinical interest in transgender care at UCLA Health. "But at the very baseline, we typically check blood count and a liver and kidney panel, then may check tests for cholesterol or diabetes or occasionally hormone levels as well."

Blood clots are the best characterized risks for estrogen therapies, says Joshua Safer, MD, an endocrinologist at the Center for Transgender Medicine and Surgery at Mount Sinai Hospital. However, they're not common. A 2017 study found that blood clots form within roughly two of 1,000 people on feminizing hormone therapy.

In some cases, potassium could build up to higher than normal levels in a condition called hyperkalemia, though it is also rare. You should check in with your doctor if you experience the following symptoms of hyperkalemia:

Weimer also says there are a few medical cases where feminizing hormone therapy may be more harmful to your health, such as having signs of breast cancer, colorectal cancer, or any cancer sensitive to estrogen.

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Feminizing hormone therapy: A guide to the medications, body effects, and health risks you should know about - Business Insider India

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In late March, shortly after New York state closed nonessential businesses and asked people to stay home, Ashley Laderer began waking each morning with a headache.

The pressure was so intense it felt like my head was going to explode, said the 27-year-old freelance writer from Long Island.

She tried spending less time on the computer and taking over-the-counter pain medication, but the pounding kept on a drumbeat accompanying her equally incessant worries about COVID-19.

Every day, I lived in fear that I was going to get it, and I was going to infect my whole family, she said.

After a month and a half, Laderer saw a neurologist. But the doctor found no physical cause. An MRI scan was clear.

He asked: Are you under a lot of stress?

People who never had the coronavirus have been reporting puzzling, seemingly unrelated symptoms: excruciating headaches, hair loss, upset stomach for weeks on end, sudden outbreaks of shingles and flare-ups of autoimmune disorders.

Theres a common thread: chronic stress. A growing body of research shows high stress over an extended time can drastically alter physical function and affect nearly every organ.

Surveys have found increasing rates of depression, anxiety and suicidal thoughts during the pandemic. But many medical experts said its too soon to measure the related physical symptoms, which generally appear months after the stress begins.

Still, some early research points to an uptick. Data from FAIR Health, a nonprofit database that provides cost information to the health industry and consumers, showed slight to moderate increases in the percentage of medical claims related to conditions triggered or worsened by stress, like multiple sclerosis and shingles. The portion of claims for the autoimmune disease lupus showed one of the biggest increases 12%.

Perhaps the strongest indicator comes from doctors reporting a growing number of patients with symptoms for which they cant determine a cause.

Dr. Shilpi Khetarpal, a Cleveland Clinic dermatologist, used to see about five patients a week with stress-related hair loss. Since mid-June, that number has jumped to 20 or 25, Khetarpal said.

In Houston, at least a dozen patients have told fertility specialist Dr. Rashmi Kudesia theyre having irregular menstrual cycles, changes in cervical discharge and breast tenderness, despite normal hormone levels.

Stress also is the culprit dentists are pointing to for increases in people with teeth grinding, tooth fractures and TMJ.

When the body feels unsafe whether from a physical threat or fear the brain signals adrenal glands to pump stress hormones. Adrenaline and cortisol flood the body, activating the fight-or-flight response. They also disrupt bodily functions that arent necessary for immediate survival, like digestion and reproduction.

When the danger is over, the hormones return to normal. But during times of chronic stress, the body keeps pumping out stress hormones, leading to increased inflammation throughout the body.

Studies link chronic stress to heart disease, muscle tension, gastrointestinal issues and even physical shrinking of the area of the brain associated with memory and learning. Some people develop new allergic reactions, said Kate Harkness, a professor of psychology and psychiatry at Queens University in Ontario.

For Alex Kostka, pandemic-related stress brought on mood swings, nightmares and jaw pain. Hed been working at a Whole Foods coffee bar in New York City about a month before the pandemic hit, suddenly anointing him an essential worker. As deaths soared, Kostka kept riding the subway to work, interacting with co-workers and working longer hours for a $2-an-hour pay increase. It left the 28-year-old feeling constantly unsafes.

It was hard not to break down on the subway the minute I got on it, Kostka said.

He began waking in the middle of the night with pain from clenching his jaw.

By the end of summer, he started using the seven free counseling sessions his employer offered. That helped, he said. But as the sessions run out, he worries the symptoms might return if hes unable to find a therapist covered by his insurance.

With chronic stress, seeing a doctor can address physical symptoms. But the root is mental, medical experts say. That means the solution will often involve stress-management techniques such as:

Kaiser Health News, a nonprofit health newsroom, is an editorially independent part of the Kaiser Family Foundation.

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Pandemic stress taking its toll on healthy people - Chicago Sun-Times

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Sleep is an essential part of the day and without getting the proper rest, it is hard to overcome the stress and the exertion which the body does all day. This sleep time is the bodys resting phase where it prepares itself for the next day. Thats why there are so many sleep aid products available in the market which help in including sleep. All of them are based on melatonin which is a naturally occurring hormone, responsible for sleep regulation. But when a person experiences sleep-related troubles, it means that his body is not making a sufficient amount of this hormone and, he needs a melatonin supplement. All of this makes sense but a new study has highlighted the link between these melatonin supplements and the deadly coronavirus.

According to this new study, melatonin supplements can actually help to fight against the coronavirus is currently involved in a global pandemic. This study is now published in the journal PLOS Biology.

Also read- Special Herbs to Add to the Air Pollution Diet

It investigated the patients who attended the Cleveland clinic from the start of this pandemic to June. Among these people, those who were using some type of melatonin supplement were less likely to diagnose positive for the coronavirus. This risk of coronavirus was 30% less for them as compared to people who dont take melatonin supplements. This risk was calculated after adjusting a number of variables for example age, health status, diet, alcohol and, smoking habits.

This study has discovered new molecular pathways, which are common in both COVID-19 and some other medical conditions. So, it implies that medicines that are FDA approved for treating those other medical conditions can also be tested on COVID-19 patients, assuming that it will help them heal.

For example, the research team identified proteins that were causing respiratory distress as well as sepsis in Covid patients. These two conditions are behind all Covid related complications and death in all patients.

Identifying more of such connections, they were finally able to shortlist 34 medicines which were approved by the US Food and Drug Administration for treating a number of diseases. All of these medicines were also helpful to heal chronic Covid symptoms.

All the data from patients was checked through an AI platform which is designed by Lerner Research Institute. It analyzed all the details collected from patients who attended this clinic which includes their history of medicines and supplements.

This connection between melatonin supplements and coronavirus risk is new and rare. There is absolutely no other study discussing this relation or coronaviruss connection with other hormones. However, it doesnt imply that people should start taking the melatonin supplements on their own as protection against coronavirus.

Previously, when the anti-Covid benefits of hydroxychloroquine came into the limelight, people rushed to the pharmacies and started taking these medicines even without consulting a doctor. Previous US President endorsed it on national television which led people to believe that this medicine will probably save them from the virus, however, this reckless use of hydroxychloroquine ended up with various deaths reported.

Only a randomized clinical-based trial on melatonin supplements given to COVID-19 patients can reveal its true benefits and how it might help in treatment. Unless that trial is done, taking melatonin supplements on your own is not recommended.

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Melatonin Supplements and Coronavirus are Weirdly Linked With Each Other - TheHealthMania

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When the children at Sophia Drakes primary school in rural Wales used to talk about what superpower theyd like, she always told them she wanted to be a shapeshifter. But I didnt want to be an animal. I didnt want to be Spider-Man or Muhammad Ali, I just wanted to change into a woman.

Drake was born biologically male. For as long as she can remember, she felt different and uncomfortable, and experimented with whatever identities and fads she could in an effort to belong. Video games saved her. When she discovered them as a child, she found she could get lost in a world where she could embody any character she liked. They took me to places where I didnt have all those issues and problems; I wasnt this confused child, I could pick who I wanted to be, she told me.

While she was growing up, Drake didnt really know what transgender was, aside from something everyone laughed about in the playground when Nadia was on Big Brother or Chandlers dad was on Friends. Her experiments with makeup and cross-dressing were always secret. When she left home for university, she developed an eating disorder and lost half her body weight in a year. Controlling her food intake fed the fantasy that she could finally shapeshift, after all. It made me feel like I had power, for the first time in my life. In 2016, she married her girlfriend, hoping the discomfort would somehow go away. It never did.

Outwardly I was this confused, shy, reserved young adult. But internally, the person I wanted to be was very different. She found that internal person impossible to suppress. That was natural, that was innate, that was me. This, she splayed her palms across her face that people saw, was the mask. I didnt want to live as a fake person.

After she got divorced, in early 2018, Drake, now working in the games industry, was determined to transition as quickly as she could. She devoured whatever information she could find on Reddit pages such as asktransgender, transgenderuk and transtimelines, and specialist forums for trans women such as Susans Place. The nearest NHS gender identity clinic told her they had a two-year waiting list for an appointment. Some people are on the waiting list for four years, she said. Thats a long time to ask someone to put their life on pause. The point where you get the referral its taken you years, often, to get to that point.

The same year, she found the online, private GenderGP service, and had some consultations via Skype with doctors who prescribed her hormone replacement therapy. She pays about 50 a month for her hormone treatment, and will need to continue with it for the rest of her life.

Drake sought out videos of facial feminisation surgery, in which trans women had their masculine features hairlines, jaws and brows reduced and remodelled. On the Channel 4 programme Embarrassing Bodies, she watched the maxillofacial surgeon Keith Altman transform the face of a transgender patient. Its an expensive procedure, and not available on the NHS in most of the UK, but for some trans women, it can be life-changing.

I first met Drake a year ago, when she was 31, six days before she was to undergo facial feminisation surgery. She was curled up in an armchair at her parents house, a converted barn in St Asaph in north Wales that used to belong to her grandparents. Her hair was pulled back by tortoiseshell sunglasses, and she wore mascara but no other makeup. She was dressed in pink Converse and a patterned shirt dress, and constantly played with her hair, her coffee cup and her ring. Her handheld games console lay on the walnut coffee table.

For Drake, the surgery was about correcting her face so that, when she looked in the mirror, she no longer felt the profound discomfort of gender dysphoria. Im not trying to make a supermodel face, I just want to see the person I always saw in my head, she said.

By and large, facial feminisation is a process of subtraction. For Drake, it is the removal of the changes that testosterone made to her face during puberty. For Keith Altman, the maxillofacial surgeon, it is the removal of bone, skin and cartilage. Facial feminisation is not considered cosmetic surgery. Its goal is to reconstruct the face, not to improve it aesthetically. In his NHS work, Altman could remake your forehead if you smashed it against a dashboard in a car accident. In his private practice, he treats a different kind of trauma: the trauma of not being read as female.

Facial feminisation is a growing industry, with private clinics springing up across the globe over the past decade. It costs twice as much as genital surgery, which used to be considered the standard procedure for gender reassignment, and has been available on the NHS since 1966. People who have undergone facial procedures say they can make an equal, if not greater, difference to a trans persons life, as the face is where gender is first read. Those who can afford it can buy the capacity to pass to go through public life without being identified as trans, without everyone knowing their business.

Drake manages a global competition for independent games developers, a job that involves travelling around the world and speaking on panels to audiences of up to 1,000 people. She is proud of being trans, she told me, and her public-facing job means her transition could never be secret. But it takes her to places where being trans can mean being very exposed.

She said she has faced aggressive transphobic comments, and lots of stares: Sometimes quite disgusting stares. The greatest pain comes when people with no malicious intent misgender her. When you are called to get on a plane and someone calls you sir thats a huge dysphoria trigger. Its like a sickening in your stomach, a pit, a crunching. I find it hard to breathe. To discover that she has not passed is to be reminded that her identity may still exist only in her mind, and not the minds of other people.

Passing means that you probably dont get stared at, pestered, misgendered. Which means you can go through an entire day, maybe, without having a major bout of dysphoria. When youve spent your whole life with dysphoria, thats massive. It means you just get on with your life.

Drake described gender dysphoria as a deep longing to be comfortable. The American Psychological Associations diagnostic and statistical manual (DSM-5) defines it as a difference between your experienced/expressed gender and assigned gender, and significant distress or problems functioning. Untreated gender dysphoria is associated with a higher risk of depression, self-harm and suicidal thoughts.

Some trans people argue that the DSM-5 definition pathologises people when it should not, and that trans is an identity, not an illness. The medical anthropologist Eric Plemons, who specialises in the politics and practice of trans medicine and surgery, told me the current definition of gender dysphoria is an improvement, and that it replaces much more pathologising things that came before it. With gender identity disorder, the identity itself was the disorder. Gender dysphoria is more about moving the problem into the social [arena]. In other words, people are suffering not from their identity, but the stress it causes them in the world. But those codes and diagnoses are currently needed in most cases for trans people to get access to the resources they need, which is unfortunate, Plemons said.

Drake had to take out a bank loan to cover two-thirds of the 14,500 cost of her facial feminisation surgery. But she saw it as vital to her wellbeing, as mental health surgery. She recognised how lucky she was to be able to afford a procedure that she could not get on the NHS. When it comes to the whole inequality in transgender treatment in the UK, I think its just short of criminal, she said.

Drake had no definite idea of how she would look after the surgery. In one sense, I expect to see the person I always wanted to be, to be comfortable, to feel euphoria, a relief from dysphoria. But in the long term, I expect to feel nothing. What does the everyday person think when they look in the mirror and see their face? Its their face.

Under angled hexagonal lights in a Brighton operating theatre in early October 2019, Drake was covered by green surgical draping that exposed only her lower face. As the surgeon, Keith Altman, prised back her cheek with a stainless steel retractor and peered inside her mouth, beams from the three bulbs fixed to his glasses illuminated the furthest interior reaches of her jawbone. From the thick brows above their surgical masks, it was evident that the two surgeons, two anaesthetists and two doctors observing were all men.

Taped to the wall above the nurses station were black-and-white portraits of the patient. In one, she looked directly into the camera with a calm determination in her eyes, bleached-blond hair, an elegant nose, full lips and dimpled cheeks. Another, above it, was shot in profile. Her jaw looked square, and her brow jutted in a prominent ridge. It was Drakes profile that threw into relief the reality that she had been born biologically male.

Altman has operated on the faces of more than 100 trans women in the past 10 years. They have ranged in age from 18 to almost 70, and include a barrister, several academics and three airline pilots. They are generally white, and wealthy enough to afford the typical 20,000-25,000 cost of facial feminisation surgery. Altman is one of only a handful of British surgeons to specialise in it.

The week before Drakes surgery, Altman operated on someone who had a thyroid shave, forehead reduction, brow lift and scalp advance (bringing the hairline forward), jaw angle shave, lip lift, cheek implants and rhinoplasty. She was on the table for seven hours. (By comparison, Drake was having pretty light work done, which was why her surgery was cheaper than average.)

Drake would undergo four procedures that morning. The mandibular angle reduction, to make the jaw narrower and the face more slender, was the first. Altman made a swift incision inside her mouth and pulled back the thin skin covering her lower jaw. A surgical nurse handed him a drill with a stainless steel bit. Music on, he declared, and soon the sound of There She Goes by the Las was wafting through the room, above the gentle whirr of Altmans drill.

When the job was done, Altman flicked his green surgical glove into a bin and left the theatre for a coffee break while the anaesthetist moved the breathing tube from Drakes nose to her mouth. Next, her brow bone would be shaved, a section of her forehead would be filed, and her hairline would be moved down. The whole procedure would take two-and-a-half hours.

When a trans woman called Candice had breast implants and genital surgery in California in 1982, she returned to her surgeon, Darrell Pratt, a few months later to say that it had had no impact on how other people perceived her in everyday life, because her face looked masculine. Pratt asked a colleague, the San Francisco-based maxillofacial surgeon Douglas Ousterhout, if there was anything he could do for his patient.

Ousterhout busied himself in the study of early-20th-century physical anthropology. He examined 1,500 male and female skulls in search of a clinical, craniofacial basis for the maleness people were apparently seeing in Candices face. He noted differences in jaws, upper lips, foreheads and chins. (Male chins are 17% longer than female chins, according to his calculations.) He considered mathematical takes on beauty, the golden ratio of pleasing proportions first theorised in ancient Greece. The formula for femininity he came up with has formed the basis for facial work ever since.

While there is no doubt that testosterone does change skulls in puberty, how much is up for discussion. Mathematical formulas for beauty have fallen out of fashion, and surgeons have different opinions about what kind of work can be done to a skull to make a face look feminine. There are no standard clinical protocols, and the 120 pages of guidelines published by the World Professional Association for Transgender Health contains a single line on FFS. It says only that there are no criteria for standards of care for facial surgery, but that mental health professionals can play an important role in helping their clients to make fully informed decisions about the timing and implications of such procedures.

Sophia Drake spent six years playing in secret with apps that make faces look more masculine or feminine, creating folders full of gender-transformed selfies and hiding them on her computer. There are sites, such as virtualffs.co.uk, that are specifically aimed at trans women, and will, for a fee, apply Ousterhout-like principles to photos. Im not trying to make myself beautiful, Drake said. I see testosterone as a poison in my body, a poison that I had to deal with for 20 years. I want to put my face to the way it would have been if testosterone had never been pumping through my body. And thats it.

Altman talked me through his working principles over coffee before Drakes surgery. Youre not doing this to beautify or rejuvenate, youre doing it to feminise, he said. If you have an attractive male face, youll end up with an attractive female face. I asked what he meant by attractive symmetrical? and he replied without missing a beat. No. I mean pleasing. What we feel is attractive. Of course, its subjective.

A female face has rounder edges and fewer angles, Altman explained. You have a more obtuse angle between your forehead and your nose here, he said, smoothing a finger between the middle of his brows. High cheekbones, a curved jawline, pointed chin. Lack of an Adams apple. Nice skin. No hair on the face, generally. And then theres the female hairline, a low hairline. The focus of his work was to bring attention to the eyes. If you file off the forehead, it looks as though the eyes have come forward, and raising the brow opens up the eyes.

Altman came to this field relatively late in his career, which has largely been spent in the NHS, remaking the faces of people who have been in car accidents, or breaking and remaking peoples jaws in orthodontic surgery. Ten years ago, a London-based GP began referring trans women to him. He contacted a surgeon in Antwerp who was experienced in facial feminisation surgery, and who invited Altman over to watch him at work. After two visits to Belgium, he began operating on his own patients in the UK.

The greatest accolade his patients can give him is to tell him that no one calls them sir any more. Thats what I want to hear. Not Im beautiful. They dont stick out. They blend in. They dont want to be going, Im a woman!, flying a flag. They can quietly go about their business, without risk of violence.

Altman was gearing up to hand his practice over to his trainee, Nikhil Maini. Demand remains steady. Many of his patients travel from Northern Ireland, where the procedure is covered by the NHS. But the lack of provision in the rest of the country leaves desperate people open to exploitation. He has heard of several trans women who have had consultations with so-called fly-in-fly-out doctors: surgeons from overseas who might not have a licence to practise in the UK, but see prospective patients in hotel rooms and offer cut-price surgery abroad.

He was confident about Drakes forthcoming surgery. She looks pretty good anyway. Shes got a nice nose. She could get away without having this done, he rubbed his jawbone but the forehead, she does need. Youll see the difference there and then on the table. I cant remember anyone whos been really upset with the outcome, he added. And certainly no one has ever said they want to be a man again.

On 28 October 2013, a thread appeared on the Susans Place message board titled Ive stopped HRT today. It had been posted by Joanna Holford, a trans woman who had had facial feminisation surgery with Altman the year before. Holford has been documenting her transition on her YouTube channel since 2012.

I pass as female but often with a second glance or prolonged look, her post read. Im tired of the stress and constant insecurity and I am not sure I can take it any more. She had written two lists, for and against detransitioning. The against column included the line: Giving up on my dream of being a fun and vivacious woman.

She decided against, in the end. She now recognises the post as a low point, triggered by the loneliness of being single for the first time in a decade and moving to a new city, and the suspicion that, despite having had facial surgery, she still wasnt always read as female.

After the surgery, Holford had moved to London to be by herself, just completely anonymous, and go stealth I hate that term, but thats what they call it, she told me. She was finding her feet enjoying life, even when a series of small incidents rattled her. She noticed people staring at her on the tube. A female colleague who had always been friendly came into work one day and blanked her. Then there was a man who looked Holford up and down in the staff canteen, then turned away, only to look back and stare again. And the time she overheard a man from another department asking the woman at the desk next to Holford whether Holford was a man or a woman, and whether she felt uncomfortable sitting so close to her.

I just died. I couldnt work out what Id done wrong. I suddenly rechecked myself. Is there something wrong with my hormones? Am I sitting in the wrong way? Is the lighting really bad? Is my clothing really bad?

Even after more surgery, and even though her videos are shared on message boards as an example of a transition to be envied, Holford still finds passing a daily effort, a daily chore. The gender dysphoria she felt before her transition has transmuted into a real, chronic paranoia. FFS isnt the golden ticket to passing. It definitely helps. If youre able to afford to do it, Id always say its a good idea. But there are so many other elements to passing: the way you handle yourself, the way you speak, the clothes that you choose, the belief you have in yourself.

Holford accepts that facial feminisation surgery perpetuates the idea that there is such a thing as a normal female face, that there is a standard expectation of what a woman should look like, and that any woman who falls outside of that is less feminine. She said the pressures women are under to look a certain way were unfair. Not just for trans women, but for women in general. There are women with heavy brows and square jaws but they still look absolutely beautiful in their own way. It puts completely unfair pressure on cisgendered women I think its awful but for trans women its double, and youd do anything just to feel like you fit in. Just to feel you can get on with your life. Because you dont want to keep fighting all the time. If this is going to help, why wouldnt you do it?

Some trans people object to facial feminisation surgery on the grounds that it reinforces a culture that cant accept trans people, instead of challenging it. Many trans women choose not to alter their bodies with surgery. In 2015, while Caitlyn Jenners feminised face was on the cover of Vanity Fair, the actor Laverne Cox began using the #TransIsBeautiful hashtag, starting a movement for trans people to be accepted without surgical intervention. Juno Roche, author of Trans Power, argues that being recognisably trans means refusing to allow gender norms to control you. The history of the trans journey is a cis male, hetrosexual, often white, middle-aged, middle-class doctor saying hes going to make you look as close in proximity to a woman so that you can pass without being noticed, so you can blend into the background, Roche told me.

Facial feminisation has allowed for the creation of a kind of two-tier system where, on the whole, the most successful trans people are beautiful people that pass, Roche continued. People who are proud to be trans, and those people who cant afford the surgery, fall into a separate category. Thats most people. And we have to create safety for everyone. It impacts on so many people, not just trans people.

Roche understands the appeal of facial surgery for so many trans women. If somebody wants to have an easy life, then boy, trans people deserve an easy life. This is a tough gig. But the truth is, if testosterone has shaped your face, it will have shaped your shoulders, your shoulder-to-hip ratio. It will have shaped your hands. Where does it stop?

There was no more easy chatter between the doctors when Altman returned to the theatre to operate on Drakes brow and forehead. This was the most difficult part of the surgery. It would remove the parts of Drakes face she thought were most male, the features she hated so much. Altman brushed sterile aqueous iodine over her face and hair, rendering her first rusty red and then yellow. He made an incision into her hairline with a swift, steady hand.

He drew back her skin in either direction from her hairline until it gathered in folds on one side at the tip of her nose, and draped back across her crown on the other. With a tiny steel mallet and a chisel, Altman set to work carefully chipping away her brow bone, before filing it with a tiny drill bit. Then he stopped, and everyone in theatre craned in to see the difference.

When he was satisfied with the result, Altman changed his gloves and turned his attention to her forehead. The MRI on the lightbox showed Drake had a large sinus cavity with a thin wall; the challenge was to saw the bone down without perforating the sinus, and the best way to do this was to remove part of her forehead entirely. Altman drew a 5cm by 3cm rectangle on to her skull with marker pen. He sliced into it with another fine tool, then prised out the section of bone. He held it in his hand as he filed it back, turning a flat plane into a gentle curve. When he put it back in place, he pulled the skin over it, tilting his head to the side to check his work. Finally, the piece of forehead was fixed back in the skull with two 4mm titanium plates, which his trainee, Maini, secured using a tiny screwdriver. Drakes skin was smoothed back for a last time. Good, Altman nodded.

The final procedures were on Drakes brow and hairline. First, the brow was lifted and anchored by two stitches. Then Altman drew in a new hairline, a centimetre below Drakes natural one, and sliced out the excess strip of skin. He fixed the hairline in place with a ladder of surgical staples at her temples and blue stitching along the top of her forehead, with a practised tilt of his wrist. Altman was right I could see the difference there and then on the operating table. Drake protruding brow bone, which she had struck with the side of her index finger when she told me about the poison of testosterone, was gone.

Altman gently rinsed the blood from Drakes hair, and wrapped her head in a tight bandage before she was wheeled out of theatre. That went well, he said, as he pulled the black-and-white portraits of Drakes old face down from the theatre wall.

The moment Drake opened her eyes in recovery, she asked the nurse beside her to take her picture, but she fell back asleep immediately. By the time she was properly awake and back in her hospital room, the Face ID on her iPhone no longer worked because her face was so swollen.

Drake had been warned that recovery could be difficult. For the first couple of days, whenever she got out of bed, she would vomit the blood that had collected in her stomach from the surgery inside her mouth. When she finally felt ready to eat, using her jaw was agony; she lived on soups, sorbets and mushed-up jelly. Drains collected the fluid that was accumulating under her skin.

But, two months later, Drake was delighted with the results. I met her in a busy cafe near Euston station when she was in London for work. The change was almost imperceptible to me, at first. But I could soon detect a new poise: her face seemed narrower, and strangely her shoulders did, too. Her dimples were more prominent, her eyes looked brighter and more expressive. There was a faint, pale pink sliver of a scar along her hairline, mostly covered by the dark roots of her fringe.

It was just enough, without being too much, she told me. The hairline frames my face better. I find that my eyes arent sunken, theyre further out. I feel that Ive got a lot more expression in my eyebrows now. Other people spot this she cupped her hands around her jaw more than I do. But when I go back and look at old pictures, I see a massive difference.

The biggest change was in Drakes demeanour. She no longer sat with her arms across her chest or played with her jewellery. She was open, at ease, comfortable.

Its made me so much happier. Calmer. I can sit and relax in ways Im not sure Ive ever been able to, she said. I dont walk around any more worrying that people are looking at me, and looking at my brow bone.

She once feared wearing too much makeup would draw attention to her brow, but now accentuated her eyes with flicked eyeliner. Where she once might have been met with stares, she told me she now gets nothing. For the first time, shes confident enough to go shopping and try on clothes in womens changing rooms as long as there are private cubicles. Before, there was a constant feeling of not wanting to make other people uncomfortable, a self-censorship. Now, I dont need to worry.

The sole NHS youth gender clinic in England and Wales has experienced an average 40% annual increase in referrals over the past four years, with many of their child patients asking for puberty blockers so their bodies will not go through the kinds of changes Drake has spent thousands of pounds trying to address. Perhaps, in the future, the availability and acceptance of hormone treatment will mean there will be fewer people requiring or wanting facial procedures. Drake thinks there may always be a need for it, because there will always be people like her who understand who they are later in life.

Facial surgery was only one step in a long journey for Drake. Things will tighten up, obviously the scar will slowly reduce over time. We wont see the full effects until next year, she said. But the authentic Sophia Drake she is looking for in the mirror is still several procedures away. On my face, Im 75% there. I still have things I want to do on my body. She nodded. Im planning other surgeries.

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Continue reading here:
'I just want to see the person I always saw in my head': the story of a face - The Guardian

Recommendation and review posted by Bethany Smith

Patients with advanced hormone receptorpositive, HER2-negative breast cancer still face acquired resistance, even with the most effective agents, namely CDK4/6 inhibitors, which have demonstrated unprecedented overall survival (OS) benefit in the metastatic setting. Investigators in the field, however, are continuing to explore pathways implicated in resistance, said Komal Jhaveri, MD, explaining that FGFR inhibitors, PI3K inhibitors, and selective estrogen receptor downregulators (SERDs) are just a few of the therapeutic classes under investigation in combination with CDK4/6 inhibitors.

Were really trying to understand how to appropriately treat our patients and [determine] the next line of therapy for a patient who progresses on a CDK4/6 inhibitor. [To that end], were trying to understand the genomic alterations and the next-generation sequencing data from tissue and plasma to better address that question, Jhaveri, a medical oncologist at Memorial Sloan Kettering Cancer Center, in New York, New York, said in an interview with OncLive.

Before diving into some of the novel combinations under investigation, she spoke to the profound effects that CDK4/6 inhibitors have had on the field.

The unprecedented, near doubling if not more of progression-free survival compared with endocrine therapy alone in the first-line setting has certainly changed our treatment paradigm, Jhaveri said. For patients who havent seen a CDK4/6 inhibitor in the first line, even in the second-line setting, weve been able to show a statistically significant progression-free [survival] benefit, justifying the use of this class of agents in the first- or second-line settings.

At the European Society for Medical Oncology Congress 2019, two approved CDK4/6 inhibitorsribociclib (Kisqali) and abemaciclib (Verzenio)were shown to prolong OS as well. According to findings from the phase 3 MONALEESA-3 trial (NCT02422615), the median OS was not reached with ribociclib versus 40 months with fulvestrant (Faslodex) alone in postmenopausal women with advanced HR-positive, HER2-negative breast cancer (HR, 0.724; 95% CI, 0.568-0.924;P=.00455).1 These data were presented shortly after the 2019 American Society of Clinical Oncology Annual Meeting, where findings from the MONALEESA-7 trial (NCT02278120) showed that the median OS was not reached with ribociclib versus 40.9 months (95% CI, 37.8-not reached), with endocrine therapy alone as first-line therapy in premenopausal women with advanced hor-mone receptorpositive, HER2-negative breast cancer (HR, 0.71; 95% CI, 0.54-0.95; P=.00973) (TABLE1,2).2

Table. Efficacy Results in MONALEESA Trials1,2

Moreover, in the phase 3 MONARCH 2 trial (NCT02107703), abemaciclib led to a median OS of 46.7 months versus 37.3 months with fulvestrant alone in patients with advanced hormone receptorpositive, HER2-negative breast cancer who progressed on prior endocrine therapy (HR, 0.757; 95% CI, 0.606-0.945; P=.01).3 Such findings have set the stage for investigation into combinations with CDK4/6 inhibi-tors and novel targets, such as FGFR, explained Jhaveri.

There is some [indication] from the PALOMA-3 [NCT01942135] and MONALEESA-2 [NCT01958021] trials, and other preclinical data, that perhaps FGFR1 amplification is a mechanism of resistance [to CDK4/6 inhibitors] and a benefit [might be seen] if one were to potentially target it with an FGFR inhibitor, said Jhaveri.

Jhaveri also pointed to research led by Carlos Arteaga, MD, director of the Simmons Comprehensive Cancer Center and associate dean of Oncology Programs at UT Southwestern Medical Center, which suggests a potential role for triplet therapy with an FGFR inhibitor and CDK4/6 inhibitor plus endocrine therapy.

Such research is being investigated in a phase 1 trial (NCT03238196) evaluating the addition of erdafitinib (Balversa) to palbociclib (Ibrance) and fulvestrant in women with FGFR-amplified estrogen receptor (ER)positive, HER2-negative breast cancer. To be eligible for enrollment, patients must have had at least 1 line of therapy in the metastatic setting. Notably, prior CDK4/6 inhibition will not serve as an exclusion criterion. As such, the preliminary results from the trial, which will be presented at the 2020 San Antonio Breast Cancer Symposium, will not only illustrate the activity of the triplet in an FGFR-amplified population but also potentially inform the utility of continuing CDK4/6 inhibition upon progression.

There are many important questions that were still now trying to understand in the clinic, and these research efforts are underway, including whether theres a role for continuing CDK4/6 beyond progression, said Jhaveri. The paradigm that we use in HER2-positive metastatic breast cancer is that targeting the HER2 pathway remains important and we continue anti-HER2 therapy beyond progression. The same is not yet clear for the utilization of CDK4/6 inhibitors beyond CDK4/6 [progression]. Thats something were actively evaluating in ongoing trials, such as MAINTAIN [NCT02632045].

Another approach under investigation is that of combined PI3K and CDK4/6 inhibition, explained Jhaveri.

CDK4/6 is downstream of the PI3K/AKT/mTOR pathway, so if one were to consider dually vertically inhibiting these pathways together, we might be able to see better synergistic activity, she said.

Key trials in this regard include PASTOR (NCT02599714), PIPA (NCT02389842), LeeBLet (NCT02154776), and TRINITI-1 (NCT02732119), among others.

ESR1 mutations are another viable target, arising in approximately 30% of women who have received prior aromatase inhibitors. Oral SERDs are currently the subject of investigation in this setting, but whether they will pan out, either as single agents or in combination, has yet to be determined, said Jhaveri.

Although the data are still in early stages, findings from a phase 1/1b trial (NCT02734615) indicated that the oral SERD LSZ102 was well tolerated and was active in combination with ribociclib or alpelisib (Piqray) in patients withER-positive breast cancer who had progressed on endocrine therapy. In the 3-arm study, investigators evaluated LSZ102 alone (arm A), in combination with ribociclib (arm B), and in combination with alpelisib (arm C). In arm A, LSZ102 elicited an objective response rate of 1.3%, a clinical benefit rate of 9.1%, and a medi-an progression-free survival of 1.8 months (95% CI, 1.7-2).4

In arm B, the addition of LSZ102 to ribociclib led to a 15.8% ORR and a CBR of 35.5%; the median PFS was 6.2 months (95% CI, 4.4-6.4). The combination of LSZ102 and alpelisib demonstrated an objective response rate of 5.4%, a clinical benefit rate of 18.9%, and a median progression-free survival of 3.5 months (95% CI, 1.8-5.5).

The rest is here:
Novel Combinations Carry CDK4/6 Inhibitors Into the Future in HR+/HER2- Breast Cancer - OncLive

Recommendation and review posted by Bethany Smith

The winning Cervical Traction Units Market report makes available the current and forthcoming technical and financial details of the industry. Few of the chief insights of this business report include; distinct analysis of the market drivers & restraints, major market players involved like industry, detailed analysis of the market segmentation & competitive analysis. It estimates CAGR values in percentages which help to know the rise or fall occurring in the market for particular product for the specific forecast period. Global Cervical Traction Units Market report also encompasses strategic profiling of key players in the market, systematic analysis of their core competencies & draws a competitive landscape for the market.

Request Sample Report @ https://beathanreports.com/request-for-sample-report/75153

The Cervical Traction Units Market report can be better employed by both traditional and new players in the industry for complete knowhow of the market. The industry analysis report brings into focus important industry trends, market size, market share estimates, and sales volume that assist industry to speculate the strategies to increase return on investment (ROI). Moreover, the market document holds a substantial importance when it is about explaining market definition, classifications, applications and engagements. With the study of competitor analysis conducted in this Cervical Traction Units Market report, industry can get fluency of the strategies of key players in the market that includes new product launches, expansions, agreements, joint ventures, partnerships, and acquisitions.

Market Analysis: Global Cervical Traction Units Market

Global Cervical Traction Units market is rising gradually with a substantial CAGR of XX% in the forecast period of 2019-2026. This rise in market value can be attributed in increase in awareness and concerns regarding the health of patients, increasing prevalence of growth hormone disorders and high expenditure in healthcare sector.

The following manufacturers are covered in this report:

Chattanooga Group

Fisiotech

V2U Healthcare

BTL

PHYSIOMED ELEKTROMEDIZIN AG

ITO

Chinesport

OG Wellness Technologies

MINATO MEDICAL SCIENCE

Bird & Cronin

Huntex Corporation

Orthoservice

Cervical Traction Units Breakdown Data by Type

Electronic

Manual

Cervical Traction Units Breakdown Data by Application

Hospital

Clinic

Rehabilitation Centers

Nursing Homes

Other

Regional and Country-level Analysis

The Cervical Traction Units market is analysed and market size information is provided by regions (countries).

The key regions covered in the Cervical Traction Units market report are North America, Europe, China and Japan. It also covers key regions (countries), viz, the U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, UAE, etc.

The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of production capacity, price and revenue for the period 2015-2026.

Request Discount About This Report @ https://beathanreports.com/discount-request-on-report/75153

Key Benefits of the report:

-This report provides an extensive analysis of the current and emerging market trends and dynamics in the global Cervical Traction Units market.

-In-depth analysis is conducted by constructing market estimations for the key market segments between 2020 and 2027.

-This report entails the detailed quantitative analysis of the current market and estimations through 2020-2027, which assists in identifying the prevailing market opportunities.

-Extensive analysis of the market is conducted by following key product positioning and monitoring the top competitors within the market framework

-Comprehensive analysis of all regions is provided that determines the prevailing opportunities in these geographies.

The report segments the Cervical Traction Units market on the basis of product type, application, and geography. On the basis of product type, it includes plastic bar cable markers, clip-on cable markers, printed adhesive cable markers, and electronic marker. On the basis of application, it is segmented into IT & telecom, energy & utility, manufacturing, construction, and others. Based on geography, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

Breakdown Data by Type

Electronic

Manual

Cervical Traction Units Breakdown Data by Application

Hospital

Clinic

Rehabilitation Centers

Nursing Homes

Other

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Table of Contents: Cervical Traction Units Market

Part 01: Executive Summary

Part 02: Scope Of The Report

Part 03: Research Methodology

Part 04: Market Landscape

Part 05: Pipeline Analysis

Part 06: Market Sizing

Part 07: Five Forces Analysis

Part 08: Market Segmentation

Part 09: Customer Landscape

Part 10: Regional Landscape

Part 11: Decision Framework

Part 12: Drivers And Challenges

Part 13: Market Trends

Part 14: Vendor Landscape

Part 15: Vendor Analysis

Part 16: Appendix

Contact Us

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About Us

At Beathan Report, we understand that the research we provide is only as good as the outcome it inspires. These reports are generated by well-renowned publishers on the basis of the data acquired from an extensive research and credible business statistics. Thats why we are proud to provide the widest range of research products, multilingual 24/7 customer support and dedicated custom research services to deliver the insights you need to achieve your goals. Take a look at few of our aspects that makes Beathan Report an asset to your business.

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Cervical Traction Units Market Analysis, Technologies & Forecasts to 2028 - The Think Curiouser

Recommendation and review posted by Bethany Smith

The winning 3-Way Infusion Extension Line Sales Market report makes available the current and forthcoming technical and financial details of the industry. Few of the chief insights of this business report include; distinct analysis of the market drivers & restraints, major market players involved like industry, detailed analysis of the market segmentation & competitive analysis. It estimates CAGR values in percentages which help to know the rise or fall occurring in the market for particular product for the specific forecast period. Global 3-Way Infusion Extension Line Sales Market report also encompasses strategic profiling of key players in the market, systematic analysis of their core competencies & draws a competitive landscape for the market.

Request Sample Report @ https://beathanreports.com/request-for-sample-report/73809

The 3-Way Infusion Extension Line Sales Market report can be better employed by both traditional and new players in the industry for complete knowhow of the market. The industry analysis report brings into focus important industry trends, market size, market share estimates, and sales volume that assist industry to speculate the strategies to increase return on investment (ROI). Moreover, the market document holds a substantial importance when it is about explaining market definition, classifications, applications and engagements. With the study of competitor analysis conducted in this 3-Way Infusion Extension Line Sales Market report, industry can get fluency of the strategies of key players in the market that includes new product launches, expansions, agreements, joint ventures, partnerships, and acquisitions.

Market Analysis: Global 3-Way Infusion Extension Line Sales Market

Global 3-Way Infusion Extension Line Sales market is rising gradually with a substantial CAGR of XX% in the forecast period of 2019-2026. This rise in market value can be attributed in increase in awareness and concerns regarding the health of patients, increasing prevalence of growth hormone disorders and high expenditure in healthcare sector.

Key Players:

The major players that are operating in the global 3-Way Infusion Extension Line market are

EffeEmme

Bicakcilar

Mediplus

Aries

Balton

MULTIMEDICAL

Micsafe Medical

Segment by Length

18cm

21cm

Others

Segment by Application

Hospital

Clinic

Others

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Key Benefits of the report:

-This report provides an extensive analysis of the current and emerging market trends and dynamics in the global 3-Way Infusion Extension Line Sales market.

-In-depth analysis is conducted by constructing market estimations for the key market segments between 2020 and 2027.

-This report entails the detailed quantitative analysis of the current market and estimations through 2020-2027, which assists in identifying the prevailing market opportunities.

-Extensive analysis of the market is conducted by following key product positioning and monitoring the top competitors within the market framework

-Comprehensive analysis of all regions is provided that determines the prevailing opportunities in these geographies.

The report segments the 3-Way Infusion Extension Line Sales market on the basis of product type, application, and geography. On the basis of product type, it includes plastic bar cable markers, clip-on cable markers, printed adhesive cable markers, and electronic marker. On the basis of application, it is segmented into IT & telecom, energy & utility, manufacturing, construction, and others. Based on geography, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

Segment by Length

18cm

21cm

Others

Segment by Application

Hospital

Clinic

Others

Request For Customization About This Report @ https://beathanreports.com/request-for-customization/73809

Table of Contents: 3-Way Infusion Extension Line Sales Market

Part 01: Executive Summary

Part 02: Scope Of The Report

Part 03: Research Methodology

Part 04: Market Landscape

Part 05: Pipeline Analysis

Part 06: Market Sizing

Part 07: Five Forces Analysis

Part 08: Market Segmentation

Part 09: Customer Landscape

Part 10: Regional Landscape

Part 11: Decision Framework

Part 12: Drivers And Challenges

Part 13: Market Trends

Part 14: Vendor Landscape

Part 15: Vendor Analysis

Part 16: Appendix

Contact Us

Beathan Report,

4004 W Lake Sammamish,

Pkway B9 Redmond,

WA 98052 United States.

Tel: +44 115 888 3028

Web: http://www.beathanreports.com

About Us

At Beathan Report, we understand that the research we provide is only as good as the outcome it inspires. These reports are generated by well-renowned publishers on the basis of the data acquired from an extensive research and credible business statistics. Thats why we are proud to provide the widest range of research products, multilingual 24/7 customer support and dedicated custom research services to deliver the insights you need to achieve your goals. Take a look at few of our aspects that makes Beathan Report an asset to your business.

See original here:
3-Way Infusion Extension Line Sales Market : Opportunities, Demand and Forecasts, 2020-2025 - The Think Curiouser

Recommendation and review posted by Bethany Smith

When visiting your doctor, whether its for your annual physical or to address a specific health issue, its reasonable to expect your practitioner to listen to your concerns, take them seriously, and do their best to give you the treatment that you need. But for folks in larger-sized bodies, that expectation rarely lives up to reality. All too often, your doctor might just prescribe one thing, regardless of your symptoms or lab results: weight loss.

This isnt theoretical. People (particularly women) have been outspoken for years about the mistreatment theyve experienced in medical settings because of their weightit was a theme in Roxane Gays 2017 memoir, Hunger, as well as the focus of a viral 2018 Self article from the columnist Your Fat Friend. Multiple studies have found that the bias doctors, nurses, and other practitioners have about weight leads to worse care and poorer health outcomes for people in larger-sized bodies. It also makes them less likely to seek health care in the first place.

Weight stigma is a huge problem in the health-care industry. But a revolutionary framework for understanding health called Health at Every Size (HAES) is seeking to provide better care for people of all sizes.

Officially, Health at Every Size is a registered trademark of the Association for Size Diversity and Health (ASDAH), formed in 2003. ASDAH defines HAES as a social justice framework that respects the diversity of body shapes and sizes, supports inclusive health care, and rejects weight discrimination and stigma against larger bodies.

Essentially, HAES is a weight-neutral approach to health. HAES-informed health-care providers focus on addressing each patients medical conditions in evidence-based ways (like medication, surgical intervention, behavior change, and therapy), without focusing on weight or encouraging weight loss.They promote the idea that it is possible to be healthy or to pursue better health without changing the size of your body.

The origins of HAES are decades-old. In 1967, writer Lew Louderback published an article in The Saturday Evening Post titled More People Should Be Fat! He outlined ideas central to the later HAES movement: that intentional weight loss is not typically sustainable long-term, that dieting can lead to food obsession and other destructive behaviors, that eating intuitively (aka listening to your bodys cues and cravings, tuning out rules about what you should or shouldnt eat, and letting go of intentional restriction) instead of dieting can improve well-being, and that Americas fear of fatness is actually about cultural aesthetics, not about health.

Louderbacks article, and the ideas it put forward, contributed to what came to be known as the fat acceptance (or size acceptance) movement. HAES is one piece of this movement.

Researcher Lindo Bacon, PhD, helped bring more widespread attention to HAES with the 2008 book Health at Every Size. In it, Dr. Bacon goes into detail about a randomized clinical trial they co-authored which found that people are actually more likely to adopt health-promoting behaviorseating nutritious foods, engaging in regular movement, etc.if they arent trying to lose weight.

Instead of using the traditional diet model, we were just supporting people in appreciating their bodies and learning how to trust their bodies and take good care of them, Dr. Bacon says. Instead of trying to control and restrict their calories, it was about learning what their bodies were asking for. Paying attention to things like hunger and fullness. And instead of using exercise as a way of punishing themselves or of burning calories, we helped people to connect with the joy of being in their bodies and moving.

The study found that while people in the traditional diet program did initially lose weight and see improvements in health markers like blood pressure, almost none of them maintained the weight loss or the health benefits after two years. Meanwhile, the HAES group saw sustained improvements in health markers over the two years. Whats more, the HAES group experienced improvements in levels of depression and self-esteem; the traditional diet group did not.

Studies have also supported Louderbacks assertion that weight loss is difficult to maintain long-term.In a 2011 review published in Nutrition Journal, Dr. Bacon and co-author Lucy Aphramor looked at existing weight loss studies and found that almost no one was able to sustain significant weight loss for more than five years. They found that dieting and intentional weight loss often led to weight cycling (the continual gaining and losing of weight), which has also proven to havenegative effects on health. Many of these findings were supported by an April 2020 meta-analysis published in The BMJ, which looked at 121 clinical trials (with nearly 22,000 total participants) and found that while most diets lead to weight loss and lowered risk of cardiovascular disease after six months, both of these effects largely disappear at the twelve-month mark.

The why of all this isnt perfectly understood, but rest assured that it isnt lack of willpower. A 2015 review found that intentional weight loss leads to physiological adaptations like a decrease in energy expenditure (calories burned), fat oxidation (using fat for energy), and leptin (a hormone that signals fullness), and an increase in appetite and ghrelin (a hormone that signals hunger). Basically, trying to lose weight may force the body to adjust in various ways to maintain its existing fat levelsmaking it harder to lose said weight or keep it off.

The HAES philosophy has been met with some skepticism in mainstream health circles. Research has long connected being at a higher weight with an increased risk of serious health conditions like heart disease, diabetes, and stroke; some experts worry that HAES could worsen those outcomes. David Katz, MD, a doctor and public health professor at Yale University, argued in 2012 that ignoring weight and the obesity epidemic will just lead to continued increases in chronic disease.

But proponents of HAES argue that our current view of weight is harmful, not helpful, to those in larger-sized bodies. By labeling it an obesity epidemic, [you] are problematizing weight, Dr. Bacon says. As soon as you problematize weight, what happens is its going to lead to people feeling bad about their bodies; its going to lead to bullying, to weight-based discrimination.

Regardless of what your weight is, we can all make good choices to support health. Lindo Bacon, PhD

Like any form of discrimination, weight stigmanegative bias and attitudes towards people at higher weightshas health consequences. A 2018 review published in BMC Medicine found that weight stigma is linked to poor metabolic health, higher levels of stress hormones, exercise avoidance, and poor mental health. HAES, on the other hand, is about making people feel empowered and respected in health-care settings, no matter their weight.

Despite this evidence, many health-care professionals continue to emphasize the importance of weight loss for health. Part of the disconnect is that HAES is a relatively new framework, and not commonly taught in most standard health-care curriculums. [HAES] is not the medical model that people are taught in school, whether theyre training to be a nurse, dietitian, doctor, or something else, says Christyna Johnson, RDN, a dietitian who practices within the HAES framework. Many providers find the HAES framework years into their clinical practice, often after seeing their patients try and fail to lose weight, she says.

Yes, and taking a HAES approach doesnt mean denying that theres some relationship between weight and health. Yes, weight is causally linked to certain medical outcomes, like diabetes, says Jennifer Gaudiani, MD, an internal medicine physician and certified eating disorder specialist. Im a completely passionate HAES supporter, and yet as an internist, scientifically, [weight and certain health outcomes] are causally linked.

The HAES movement takes this reality into account. Health at Every Sizeis not suggesting that everybody is at their healthiest best at every weight, Dr. Bacon says. What it is suggesting, though, is that regardless of what your weight is, we can all make good choices to support health, and thats all we want to do.

HAES also challenges the idea that fat people are unhealthy, and that people who take care of themselves are thin, Dr. Gaudiani says. In reality, its much more complicated than that. (Just look at the Body Mass Index, which has been shown to be inaccurate for many people.) Many people at higher weights can be metabolically healthymeaning they have medically ideal levels of blood glucose, cholesterol,and other biomarkers. Plus, a 2015 study of over 100,000 Danish adults found that those in the overweight category (with a BMI range of 25-30) actually lived the longest, on average, compared to people in other weight categories. Thats not to say that havinga larger-sized body automatically translates to longevity, but its proof that the relationship between weight and health is complex.

Some experts question the plausibility of metabolically healthy obesity. However, most studies on the subjectlike a 2019 review, which found that people with larger-sized bodies and who are metabolically healthy still are at a higher risk for chronic diseases like type 2 diabetes and heart disease than their lower-weight counterpartsdont control for the effects of experienced weight stigma or weight cycling, both of which are very common among higher-weight people and have been shown to worsen health outcomes and increase risk of diabetes, heart disease, stroke, and even early mortality.

Again, none of the evidence above denies that there is some relationship between weight and health. But HAES practitioners (and research) argue that just because weight is causally linked to certain conditions doesnt mean that all higher weight people have or will have those conditions. Thus, Health at Every Size makes health more accessible to people in larger bodies by acknowledging that weight isnt as modifiable as weve traditionally believed, and encouraging people to improve health in other ways.

Its also about meeting people where they are. Johnson explains that within the HAES framework, the relationship between a health-care provider and their patient is collaborative and takes individual circumstances into account. Is this person living at or below the poverty level? Is this person in a non-binary or trans body? Is this person in a disabled body? Is this person living with a mental illness or a chronic illness? Does this person have generational trauma? All these intersections can affect a persons health, she says, and can inform what type of care they need.

The HAES approach might also make people in larger bodies more likely to seek care. Lesley Williams, MD, a family medicine physician and certified eating disorder specialist who practices HAES, says that many patients in larger bodies come to her because they feel like their previous doctor wasnt listening to them. The patient would come in with a specific problemor for a routine checkup, with no problems at alland the doctor would invariably tell them to lose weight, minimizing whatever underlying problem was at hand. Many would then avoid the doctors office going forward, for fear of being stigmatized or feeling disrespected.

Although there is a peer-reviewed HAES curriculum available online for providers and others who are interested, theres no credential or certification required. [HAES] is an inclusive and compassionate health-care model that allows people to seek and define health for themselves, Johnson says. In other words, it will look different for everyone, because its about honoring each persons unique body and unique needs.

If youre looking for a HAES-informed health-care provider, theres an online database that you can search by area or specialty. But its also something that you can implement in your own life by vowing to stop fixating on weight and instead focusing on healthy behaviors.

And, look, if youre not on board with every aspect of the HAES movement, thats okay. Its a huge paradigm shift that goes against what most of us have been taught. But no matter your current beliefs on weight and health, its worth acknowledging the fact that weight loss isnt actually possible for everyone, and that dieting and restriction can actually cause physical harm. The underlying goal of HAES is to make health and quality health care accessible to more people, which is hard to argue with.

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The Health at Every Size Philosophy Aims To Make Health Care More Inclusive of Larger-Sized Bodies - Well+Good

Recommendation and review posted by Bethany Smith

Sometimes people think of estrogen as a female hormone. However, all human bodies require estrogen to function correctly.

Estrogen is a hormone that naturally occurs in a persons body. Levels of estrogen that are too high or too low can cause a person to have health problems.

This article will discuss the role of estrogen in the male body, symptoms of high or low estrogen levels, and how people can treat irregular levels.

Estrogen is a sex hormone found in both males and females, although females have higher estrogen levels than males do.

The ovaries, testes, fat cells, and adrenal glands produce estrogen. It is important for female puberty and controlling the menstrual cycle. Estrogen is also important for the male reproductive system.

There are three types of estrogen:

Testosterone can be converted into estradiol using the enzyme aromatase. Estradiol is used by the male body for:

Estrogen also has other functions in the human body. It can help control cholesterol levels and maintain bone and heart health. It also affects mood, skin, and other tissues of the body.

The amount of estrogen a male should have will depend on their age and health history. According to the Endocrine Society, an adult male should have an estradiol level of 1040 picograms per milliliter (pg/mL) and an estrone level of 1050 pg/ml.

A person who is concerned about their levels of estrogen should speak to their doctor.

Although the male body needs estrogen to function correctly, too much estrogen can cause health problems.

Increased levels of estrogen can cause symptoms such as infertility, erectile dysfunction, and depression.

A person who is concerned about their estrogen levels should contact their doctor.

Low levels of estrogen in the male body can produce symptoms such as:

Researchers found that males with cardiovascular disease had lower levels of testosterone and estrogen.

Hypogonadism, a condition that can cause a decrease in sex hormones, can be a cause of low estrogen in males.

Further research is needed to confirm the symptoms that low estrogen can have on the male body.

Learn more about low estrogen here.

High levels of estrogen can cause a variety of problems in the male body. Symptoms of high estrogen levels in males include:

Increases in estrogen in males can also be an indicator of the following conditions:

Research into the effect of estrogen on migraines indicates that males with higher estrogen levels may be at higher risk of having migraines. However, researchers note that further study is required to confirm these findings.

A 2019 study into the link between high estrogen levels and diffuse cutaneous systemic sclerosis, an autoimmune disease, in males over 50 found that participants with significantly high estrogen levels had higher risk of cardiac involvement or death.

Aromatase excess syndrome and alcohol use disorder may be causes of increased estrogen in males.

Learn more about high estrogen here.

Reducing alcohol intake may cause a drop in estrogen levels.

There have also been studies suggesting that certain types of food may reduce estrogen levels. However, there is no definitive research to confirm the estrogen-lowering effects these foods have.

A male who wants to lower their estrogen levels should speak to their doctor. Certain medications are available that can help lower estrogen. They include selective estrogen receptor modulators and aromatase inhibitors.

A male who is experiencing symptoms of low estrogen should speak to their doctor about treatment options.

Hormone replacement therapy can help treat low estrogen levels in males caused by hypogonadism. A doctor may administer testosterone using a patch, an injection, a gel, or a product absorbed by the gums.

A person who experiences any symptoms of low or high estrogen levels should speak to their doctor.

The doctor may perform tests, such as blood test or urine sample test, in order to determine a persons estrogen levels. The doctor may then discuss what treatment options will suit the person best.

Levels of estrogen that are too high or too low can cause problems in males.

Low or high levels of estrogen can be indicators of underlying health problems.

A person who experiences symptoms of high or low estrogen levels should speak to their doctor.

Read the original post:
Estrogen in men: Symptoms of high and low levels, and more - Medical News Today

Recommendation and review posted by Bethany Smith

ENGLEWOOD, CO / ACCESSWIRE / November 11, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that management will present a corporate overview at the Jefferies 2020 Virtual London Healthcare Conference on Wednesday, November 18 at 1:45pm ET / 6:45pm GMT.

A webcast of the presentation will be available at the following link: https://wsw.com/webcast/jeff141/aytu/1873875

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist®, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex® Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal® ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid antibody test and rapid antigen tests. These assays are used in the rapid, qualitative diagnostic assessment of the 2019 Novel Coronavirus. Additionally, Aytu recently licensed worldwide rights to develop the Healight technology platform. Healight is an investigational medical device being studied as a prospective treatment for COVID-19 and other respiratory infections.

Aytu also operates a consumer health subsidiary, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human® marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the regulatory and commercial risks associated with introducing the COVID-19 rapid tests, the accuracy of the COVID-19 rapid tests as compared to other COVID-19 tests, market acceptance of the tests, the ability to obtain FDA approval or authorization for the tests, our ability to obtain sufficient tests to meet consumer demand, if any, the manufacturers' ability to scale up manufacturing to meet customer demand, if any, reputation risks if the tests are not as effective as anticipated, and that the current regulatory environment continues to permit the sale of the tests. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James Carbonara Hayden IR (646) 755-7412 james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/615765/Aytu-BioScience-to-Present-at-the-Jefferies-2020-Virtual-London-Healthcare-Conference-Wednesday-November-18-at-145pm-ET

View original post here:
Aytu BioScience to Present at the Jefferies 2020 Virtual London Healthcare Conference Wednesday, November 18 at 1:45pm ET - Stockhouse

Recommendation and review posted by Bethany Smith

Global Testosterone Replacement Therapy Market Report, History and Forecast 2015-2024, Breakdown Data by Manufacturers, Key Regions, Types and Application is a highly comprehensive research document released by 360 Research Reports that provides a reliable source of the global Testosterone Replacement Therapy market study. Major players, competitive intelligence, market dynamics and geographic opportunities are discussed in detail in the report. Independent sections cover each of the major regions, as well as the trends for Testosterone Replacement Therapy market products within those regions. The report includes market estimations and trends through the forecast period and analyses market dynamics across the major geographies. The report also discusses recent developments and product portfolios of the key players.

COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets.

Final Report will add the analysis of the impact of COVID-19 on this industry.

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Short Description About Testosterone Replacement Therapy Market:

Testosterone replacement therapy (TRT) is a class of hormone replacement therapy in which androgens, often testosterone, are replaced. Testosterone replacement therapy (TRT) is an FDA-approved medical treatment for men of any age who have low testosterone, a hormone necessary for male sexual development.

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The research covers the current Testosterone Replacement Therapy market size of the market and its growth rates based on 5-year records with company outline ofKey players/manufacturers:

Scope of the Testosterone Replacement Therapy Market Report:This report focuses on the Testosterone Replacement Therapy in global market, especially in North America, Europe and Asia-Pacific, South America, Middle East and Africa. This report categorizes the market based on manufacturers, regions, type and application.Testosterone deficiency, also referred to as hypogonadism, is a common problem among men aged between 40 and 79 years, with some studies stating that nearly 30% of all men worldwide are affected by hypogonadism. As the incidence of testosterone deficiency increases, it is expected that the demand for TRT will also show a simultaneous increase.The global average price of testosterone replacement therapy is in the decreasing trend, from 45.4 USD/Unit in 2012 to 34.9 USD/Unit in 2016. With the situation of global economy, prices will be in decreasing trend in the following five years.The classification of testosterone replacement therapy includes gels, injections, patches and other types, and the proportion of gels in 2016 is about 72%.Testosterone replacement therapy is widely sold in hospitals, clinics and other field. The most proportion of testosterone replacement therapy is sold in clinics, and the consumption proportion is about 43%.North America region is the largest supplier of testosterone replacement therapy, with a production market share nearly 86% in 2016. Europe is the second largest supplier of Testosterone Replacement Therapy, enjoying production market share nearly 9.9% in 2016.North America is the largest consumption place, with a consumption market share nearly 83% in 2016. Following North America, Europe is the second largest consumption place with the consumption market share of 12%. Market competition is intense. AbbVie, Endo International, Eli Lilly, Pfizer, Actavis (Allergan)Bayer, etc. are the leaders of the industry. The top five players together held about 80% of the market in the same year and they hold key technologies and patents, with high-end customers; have been formed in the monopoly position in the industry. The worldwide market for Testosterone Replacement Therapy is expected to grow at a CAGR of roughly -4.2% over the next five years, will reach 1410 million US$ in 2023, from 1820 million US$ in 2020, According to a New Research study.

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Report further studies the market development status and future Testosterone Replacement Therapy Market trend across the world. Also, it splits Testosterone Replacement Therapy market Segmentation by Type and by Applications to fully and deeply research and reveal market profile and prospects.

Major Classifications are as follows:

Major Applications are as follows:

Geographically,this report is segmented into severalkey regions, with sales, revenue, market share and growth Rate of Testosterone Replacement Therapy in these regions, from 2014 to 2024, covering

This Testosterone Replacement Therapy Market Research/Analysis Report Contains Answers to your following Questions

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Major Points from Table of Contents:

Market Overview1.1 Testosterone Replacement Therapy Introduction1.2 Market Analysis by Type1.3 Market Analysis by Applications1.4 Market Dynamics1.4.1 Market Opportunities1.4.2 Market Risk1.4.3 Market Driving Force

2.Manufacturers Profiles

2.4.1 Business Overview2.4.2 Testosterone Replacement Therapy Type and Applications2.4.2.1 Product A2.4.2.2 Product B

3.Global Testosterone Replacement Therapy Sales, Revenue, Market Share and Competition By Manufacturer (2019-2020)

3.1 Global Testosterone Replacement Therapy Sales and Market Share by Manufacturer (2019-2020)3.2 Global Testosterone Replacement Therapy Revenue and Market Share by Manufacturer (2019-2020)3.3 Market Concentration Rates3.3.1 Top 3 Testosterone Replacement Therapy Manufacturer Market Share in 20203.3.2 Top 6 Testosterone Replacement Therapy Manufacturer Market Share in 20203.4 Market Competition Trend

4.Global Testosterone Replacement Therapy Market Analysis by Regions

4.1 Global Testosterone Replacement Therapy Sales, Revenue and Market Share by Regions4.1.1 Global Testosterone Replacement Therapy Sales and Market Share by Regions (2014-2019)4.1.2 Global Testosterone Replacement Therapy Revenue and Market Share by Regions (2014-2019)4.2 North America Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.3 Europe Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.4 Asia-Pacific Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.6 South America Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)4.6 Middle East and Africa Testosterone Replacement Therapy Sales and Growth Rate (2014-2019)

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5.Testosterone Replacement Therapy Market Forecast (2020-2024)5.1 Global Testosterone Replacement Therapy Sales, Revenue and Growth Rate (2020-2024)5.2 Testosterone Replacement Therapy Market Forecast by Regions (2020-2024)5.3 Testosterone Replacement Therapy Market Forecast by Type (2020-2024)5.3.1 Global Testosterone Replacement Therapy Sales Forecast by Type (2020-2024)5.3.2 Global Testosterone Replacement Therapy Market Share Forecast by Type (2020-2024)5.4 Testosterone Replacement Therapy Market Forecast by Application (2020-2024)5.4.1 Global Testosterone Replacement Therapy Sales Forecast by Application (2020-2024)5.4.2 Global Testosterone Replacement Therapy Market Share Forecast by Application (2020-2024)

6.Sales Channel, Distributors, Traders and Dealers6.1 Sales Channel6.1.1 Direct Marketing6.1.2 Indirect Marketing6.1.3 Marketing Channel Future Trend6.2 Distributors, Traders and Dealers

7.Research Findings and Conclusion

8.Appendix8.1 Methodology8.2 Data Source

Continued..

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Global Testosterone Replacement Therapy Market 2020 : Industry Analysis by Top Countries Data Definition, Size, Share, Segmentation and Forecast data...

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq: GBIO) is an innovative genetic medicines company creating a new class of non-viral gene therapy. Today the company reported recent business highlights and third quarter financial results.

2020 continues to be a year of progress and execution for Generation Bio as we advance our non-viral gene therapy approach, said Geoff McDonough, M.D., president and chief executive officer of Generation Bio.Despite the challenges of the COVID-19 pandemic, we remain on-track to advance our lead programs into IND-enabling preclinical development next year. We believe our strong cash balance positions us well to execute on our ambitions into 2023.

Recent Business Highlights

This period marks an expansion of our focus beyond our platform to include preclinical development and readiness for the clinic. To support this effort, I am pleased to announce the appointment of Tracy Zimmermann to chief development officer. Tracy will lead our pre-clinical development programs across the portfolio, building on the excellent foundation she has created since joining Generation Bio in 2018. Tracys new role allows for Doug Kerr to focus on building our clinical development capabilities as chief medical officer. Together with Matt Stanton, our chief scientific officer, Tracy and Doug make a terrific, complementary leadership team for our R&D work, Dr. McDonough said. A summary of the leadership appointments follows.

Dr. McDonough continued, Separately, Mark Angelino, our chief operating officer and co-founder, will undertake a planned transition from Generation Bio to return to early stage company formation work in early 2021. Although too soon for farewells, we are indebted to Mark for his vision and leadership in forming and building our community here.

Selected Anticipated Company Milestones

Upcoming Investor Conference Presentations

Management will present at two upcoming investor conferences:

Live webcasts of the presentation and the fireside chat will be available in the investor section of the company's website atwww.generationbio.com. The webcasts will be archived for 60 days following the presentations.

Financial Results

About Generation Bio

Generation Bio is an innovative genetic medicines company focused on creating a new class of non-viral gene therapy to provide durable, redosable treatments for people living with rare and prevalent diseases. The companys non-viral platform incorporates a proprietary, high-capacity DNA construct called closed-ended DNA, or ceDNA; a cell-targeted lipid nanoparticle delivery system, or ctLNP; and an established, scalable capsid-free manufacturing process. The platform is designed to enable multi-year durability from a single dose of ceDNA and to allow titration and redosing if needed. The ctLNP is designed to deliver large genetic payloads, including multiple genes, to specific tissues to address a wide range of indications. The companys efficient, scalable manufacturing process supports Generation Bios mission to extend the reach of gene therapy to more people, living with more diseases, in more places around the world.

For more information, please visit http://www.generationbio.com.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about its strategic plans or objectives, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities, the initiation and completion of preclinical studies and clinical trials and clinical development of the Companys product candidates; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; expectations for regulatory approvals to conduct trials or to market products; challenges in the manufacture of genetic medicine products; the Companys ability to obtain sufficient cash resources to fund the Companys foreseeable and unforeseeable operating expenses and capital expenditure requirements; the impact of the COVID-19 pandemic on the Companys business and operations; as well as the other risks and uncertainties set forth in the Risk Factors section of the Companys most recent quarterly report on Form 10-Q, and in subsequent filings the Company may make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Companys views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Companys views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Companys views as of any date subsequent to the date on which they were made.

Contacts:

InvestorsChelcie ListerTHRUST Strategic Communicationschelcie@thrustsc.com910-777-3049

MediaStephanie SimonTenBridge Communicationsstephanie@tenbridgecommunications.com617-581-9333

GENERATION BIO CO.CONSOLIDATED BALANCE SHEET DATA(unaudited)(in thousands)

GENERATION BIO CO.CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited)(in thousands, except share and per share data)

Read more:
Generation Bio Reports Third Quarter 2020 Business Updates and Financial Results - GlobeNewswire

Recommendation and review posted by Bethany Smith

Final Report will add the analysis of the impact of COVID-19 on this industry

Global Gene Therapy Market forecast 2020-2024 market report includes types, applications, regions analysis and discussion of important industry trends, market share estimates and profiles of the leading industry players. Gene Therapy Market share report covers the manufacturers , price, revenue, gross profit, these data help the end user know about the competitors better.

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The content of the study subjects, includes a total of 15 chapters:

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Table of Contents of Gene Therapy Market:

1 Market Overview

1.1 Gene Therapy Introduction

1.2 Market Analysis by Type

1.2.1 Type 1

1.2.2 Type 2

1.3 Market Analysis by Applications

1.3.1 Application 1

1.3.2 Application 2

1.4 Market Analysis by Regions

1.4.1 North America (United States, Canada and Mexico)

1.4.2 Europe (Germany, France, UK, Russia and Italy)

1.4.3 Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

1.4.4 South America, Middle East and Africa

1.4.4.5 Turkey Market States and Outlook (2014-2024)

1.5 Market Dynamics

1.5.1 Market Opportunities

1.5.2 Market Risk

1.5.3 Market Driving Force

2 Manufacturers Profiles

2.1 Manufacture

2.1.1 Business Overview

2.1.2 Gene Therapy Type and Applications

2.1.2.1 Product A

2.1.2.2 Product B

2.1.3 Manufacture Gene Therapy Sales, Price, Revenue, Gross Margin and Market Share (2019-2019)

3 Global Gene Therapy Sales, Revenue, Market Share and Competition by Manufacturer (2019-2019)

3.1 Global Gene Therapy Sales and Market Share by Manufacturer (2028-2019)

3.2 Global Gene Therapy Revenue and Market Share by Manufacturer (2018-2019)

3.3 Market Concentration Rate

3.3.1 Top 3 Gene Therapy Manufacturer Market Share in 2019

3.3.2 Top 6 Gene Therapy Manufacturer Market Share in 2019

3.4 Market Competition Trend

13 Sales Channel, Distributors, Traders and Dealers

13.1 Sales Channel

13.1.1 Direct Marketing

13.1.2 Indirect Marketing

13.1.3 Marketing Channel Future Trend

13.2 Distributors, Traders and Dealers

14 Research Findings and Conclusion

15 Appendix

15.1 Methodology

15.2 Data Source

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Gene Therapy Market 2020 Size, Share, Trends Analysis Report by Application, Region (North America, South America, Asia, and Europe) and Forecasts to...

Recommendation and review posted by Bethany Smith

Global Hemophilia Gene Therapy Market report explains the fundamental industry aspects and market statistics. The latest technological advancement, market plans, policies, growth opportunities and industry risks are elaborated. The two important segments of the report namely market revenue in (USD Million) and market size (k MT) is described. Hemophilia Gene Therapy Industry scope, market concentration and Hemophilia Gene Therapy presence across different topographies is presented in detail.

A visionary perspective about Hemophilia Gene Therapy Industry covers the geographical continents namely North America, European countries, Asia-Pacific, South America, Middle East & Africa. In the next segment, prominent Hemophilia Gene Therapy industry players, their company profiles, product details, and market size is described. Also, the SWOT analysis of these players, business plans & strategies are covered. The product definition, Hemophilia Gene Therapy classification, type and cost structures are covered.

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Hemophilia Gene Therapy Market Leading Players:

BioMarinFreeline TherapeuticsuniQureBioverativSpark TherapeuticsSangamo TherapeuticsUltragenyxShire PLC

Market Segment Analysis

By Types:

Hemophilia AHemophilia B

By Applications:

Hemophilia A Gene TherapyHemophilia B Gene Therapy

On a regional level, Hemophilia Gene Therapy production value and growth rate from 2015-2019 is presented. The detailed analysis of emerging industry segments and sub-segments are explained. Macro-economic plans & policies, economic status, cost structures and value chain analysis is covered. The Hemophilia Gene Therapy competitive landscape view, manufacturing base, production process analysis and upstream raw materials are evaluated.

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The gross margin, consumption pattern, growth rate of Hemophilia Gene Therapy is studied precisely. The top industry players are covered on a regional level and country level with the analysis of their revenue share from 2015-2019. Furthermore, forecast Hemophilia Gene Therapy industry status is determined by analysis of expected market share, volume, value and development rate. The forecast Hemophilia Gene Therapy industry view is presented from 2020-2027.

Abstract of implemented Research methodology and data sources used to derive Hemophilia Gene Therapy Market statistics:

The information presented in Hemophilia Gene Therapy Report includes qualitative and quantitative analysis. Under the qualitative analysis part, Hemophilia Gene Therapy status, trends, manufacturing base, distribution channels, market position, a competitive structure is covered. Also, complete details on product development, cost structures, growth opportunities, industry plans and policies are analysed. Under the qualitative analysis part, market size (from 2015-2019), sales, revenue, gross margin statistics, revenue is covered. Also, industry size by Hemophilia Gene Therapy type, application, demand and supply scenario, and economic status is explained.

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Our research methodology comprises of 80% primary and 20% secondary research. To derive the supply side Hemophilia Gene Therapy industry statistics, we conduct an interview with competitors, manufacturers, OEMs, raw material providers and others. To derive sales statistics, Hemophilia Gene Therapy industry information is gathered from distributors, traders and market dealers. Similarly, to analyse demand-side statistics we interview the end users, consumers and conduct custom surveys.

Under secondary research technique, the Hemophilia Gene Therapy production, sales and consumption statistics are gathered from company reports, annual publications, SEC filings, government data, case studies, custom groups and demographics.

Abstract of the report:

Remarkable Attributes Of Hemophilia Gene Therapy Report:

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