SALT LAKE CITY, March 18, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, announced that the National Comprehensive Cancer Network (NCCN) updated its professional guidelines for prostate cancer to recommend biomarker-based testing for men with unfavorable intermediate and high-risk disease. Myriads Prolaris test was one of only two prognostic tests for prostate cancer recommended by NCCN for the new expanded indications and is now broadly recommended for use in low, intermediate and high-risk disease.

NCCNs endorsement of Prolaris testing in unfavorable intermediate and high-risk disease is a major step forward for men and will help in expanding access to testing, said Todd D. Cohen, M.D., vice president of Medical Affairs for Urology at Myriad Genetics. Recent data demonstrated the ability of Prolaris to determine which men will benefit from multi-modality therapy and who can avoid unnecessary morbidity associated with aggressive treatment.

In a recent study of 718 men presented at the American Society of Clinical Oncology Genitourinary Cancer Symposium in San Francisco, Myriad demonstrated the ability of Prolaris to predict which prostate cancer patients with unfavorable intermediate or high-risk disease would benefit from additional treatment. In the study, patients above the high-risk threshold saw a statistically significant benefit from multi-modality therapy leading to a reduction in the risk of metastases where patients below the high-risk threshold saw no statistical benefit from additional treatment and could avoid the morbidity associated with increased therapy.

About ProlarisProlaris is a genetic test developed by Myriad that directly measures tumor cell growth. The Prolaris test paired with both prostate-specific antigen (PSA) and Gleason provides the level of aggressiveness of a patients individual prostate cancer. PSA and Gleason only have the ability to identify how far the cancer has progressed thus far. However, when these are combined with a Prolaris test score, patients get an accurate assessment of how aggressively that cancer will progress over the next ten years. For more information visit: http://www.prolaris.com

About Myriad GeneticsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra, Prequel, ForeSight, GeneSight and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to NCCNs endorsement of Prolaris testing in unfavorable intermediate and high-risk disease helping to expand access to testing; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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NCCN Updates Professional Guidelines Recommending Biomarker Testing for Unfavorable Intermediate and High-Risk Patients with Prostate CancerProlaris...

Recommendation and review posted by Bethany Smith

Research for novel cancer therapeutics pool in massive investments in red biotechnology market

Player leverage AI to extract potential of red biotechnology in preserving health and controlling diseases

ALBANY, New York, March 18, 2020 /PRNewswire/ -- A wide assortment of applications of genetic engineering technology, vaccine research, and biologics have helped expand the potential of the red biotechnology market, which was worth US$314.2 billion in 2018. Growing application of biotechnology in medicine has unlocked promising prospects particularly in chronic and rare diseases treatment.

Future Outlook

Emerging applications of gene therapy, pharmacogenomics, and genetic testing in the preservation of health, notably in oncology, are shaping the future growth trajectories in the red biotechnology market. By 2027-end, the revenues are projected to reach US$512 bn, clocking CAGR of ~6% from 2019 to 2027. In developing countries, many new collaborations are likely to be forged, defining future initiatives on cloud-based technology and AI.

Analysts' Viewpoint

"Staying abreast with standardized regulations and regulatory norms will enable biotechnology and pharmaceutical companies to chart new growth avenues in the red biotechnology market," note the analysts. Marked prevalence of cancer world over expands scope for market stakeholders, they further opine.

Key Takeaways of Red Biotechnology Market Study

Of the various end users, biopharmaceutical industries are anticipated to account for a promising slice of global revenues

Several drug candidates in late phase of clinical trials define growth

Gene therapy is expected to garner a promising CAGR during 2019 2027; focus on treating genetic diseases shape the growth

Of the various key regional markets, North America leads the pack; however most lucrative opportunities are found in Asia Pacific

Asian economies likely to be center of new revenue streams in Asian economies due to demand for high-quality and cost-effective drugs

Explore 176 pages of top-notch research, incisive insights, and detailed country-level projections. Gain business intelligence on Red Biotechnology Market (Application: Biopharmaceutical Production, Gene Therapy, Pharmacogenomics, and Genetic Testing; End User: Biopharmaceutical Industry, CMOs & CROs, Research Institutes, and Others) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019 - 2027 at https://www.transparencymarketresearch.com/report-toc/2063

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Red Biotechnology Market: Key Driving Factors and Promising Avenues

A few striking trends in investments in healthcare sector shape the evolution of the red biotechnology market. Growing number of clinical trials in cancer research and incessant efforts of biotechnology players to find therapies for rare diseases are boosting the pace of new drug approvals. A few statistics support research and developments in aforementioned realms.

Per the U.S.-based agency National Institutes of Health (NIH), there may be as many as 25-30 millions of Americans with a rare disease at any point in time.

According to a statistics in a recent American Cancer Society's journal, cancer mortality rate continues to drop. Red biopharmaceuticals has occupied crucial role to this end.

According to an article in NCBI, chronic diseases form the most costly health conditions in the U.S., including cancer. This is key to growing clinical trials that harness technologies in red biopharmaceutics. A case in point is cell-based vaccine technology.

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Red Biotechnology Market: Regional Outlook

Among the various regional markets, North America leads the pack, and is expected to retain its dominance throughout the assessment period. Spate of investments in clinical trials for chronic and rare diseases and massive investments in developing cancer drug pipeline have helped the North America red biotechnology market to reach dominant position. Stakeholders are harnessing artificial intelligence will continue new prospects in the regional market. Prominently, relentless efforts of biopharmaceutical players in the U.S. test new drugs and vaccines form crucial trend in the growth of this regional market.

On the other hand, a growing numbers of players have shifted their attention to Asian economies to tap into the vast latent potential in personalized healthcare. The region will see new strategic collaborations among healthcare companies and biopharmaceutical players.

Red Biotechnology Market Competition Landscape

Growing demand for biologics and biosimilars in developing economies has been crucial to the expansion of red biotechnology prospects, globally. Most notably, Asia Pacific has been the key focus for players to gain competitive edge over their peers and rivals.

Biopharmaceutical players have begun inking new partnership deals and distribution agreements in the region, particularly in on oncology therapeutics and development. Focus on novel therapeutics and disease pathways for bettering human health has been one of the key winning imperatives for companies in the red biotechnology market. To consolidate their positions, top players are aiming to expedite product approvals for rare and chronic diseases, and have increased their stakes in advanced stages of clinical trials.

A handful of big pharmaceutical and biotech players, and multinational healthcare companies jointly contribute half of the global revenues. These include Pfizer Inc., Gilead Sciences Inc., Amgen Inc., and F. Hoffmann-La Roche.

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The red biotechnology market is segmented on the basis of application, end user, and region.

Explore Transparency Market Research's award-winning coverage of the global Healthcare industry:

Bioinformatics Market- The global bioinformatics market is projected to grow at a significant CAGR during the forecast period and is likely to touch a valuation of US$9.1 bn by 2018.

Gene Therapy Market -Expanding at a stellar, double-digits CAGR (Compound Annual Growth Rate) of 40% over the forecast period of 2018 to 2026, the global gene therapy market is a dizzying trajectory, marking out a rosy landscape for players operating in the playfield. As per a Transparency Market Research report, based on extensive primary and secondary research, states that over the period states, the market would accrue a worth of USD 5164.03 million a steep and impressive increase from the USD 17 million worth noted in 2017.

Biosimilars Market- Advancements in oncology settings are improving patient quality of life. Due to effective biosimilars, healthcare providers are able to receive better outcomes in several cancer patients who can opt for convenient treatments such as a painless injections rather than receiving a lengthy chemotherapy session. Patent expiry of biologic drugs for the treatment of cancer are creating a scope for incremental opportunities. As such, oncology indication segment of the biosimilars market is estimated to reach a value of~US$ 21.1 Bnby the end of2027.

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Exploring Avenues in Personalized Medical Care Defines Advances in Red Biotechnology Market: Valuation to Touch Massive US$512 Bn By 2027, Finds...

Recommendation and review posted by Bethany Smith

Rapid and Scalable RT-PCR Assay is Pending Approval for Emergency Use Authorization

- BGI's test already has approvals through CE-IVD and China's NMPA

- Kits are currently being distributed to more than 50 countries and regions worldwide

- Highly sensitive and quick test with 3-hour turnaround time

CAMBRIDGE, Mass., March 18, 2020 /PRNewswire/ --BGI Genomics. Co. Ltd. (SZSE:300676) and US subsidiary BGI Americas Corp., today announced that its Real-Time Fluorescent RT-PCR test for detecting SARS-CoV-2 is now commercially available in the United States. With the updated guidance from FDA issued on March 16, BGI's detection kit is eligible to be used immediately to expedite clinical testing for the novel coronavirus.

BGI is submitting a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for itsSARS-CoV-2 testand expects to receive formal EUA in the near future. BGI has been in regular communication with the FDA about its testing data since submitting information to the agency more than a week ago.

"We appreciate the FDA's move to open up the market for our diagnostic test kits," said BGI Genomics CEO Yin Ye. "Our goal is to deploy our maximum capability to support efforts to contain the virus worldwide.Our technology has been put to the test on the front lines of fighting this novel coronavirus outside the US. We are now bringing rapid and accurate testing capability at scale to bolster detection efforts throughout the US and help more patients receive accurate diagnosis."

BGI has been on the forefront of testing for SARS-CoV-2. Following the outbreak of the novel coronavirus in China, BGI was among the first few companies that developed the diagnostic test that received emergency approval from China's National Medical Products Administration (NMPA) on January 26, 2020, followed by CE-IVD marking on March 2, 2020. BGI quickly scaled up manufacturing and currently has a daily capacity of up to 300,000 reactions per day. BGI has performed over 500,000 SARS-CoV-2 tests in its own central laboratories in China and is distributing its SARS-CoV-2 detection kits to more than 50 countries and regions around the world.

BGI is bringing its full genomics expertise and resources to the fight against the 2019 novel coronavirus around the world. BGI's long history of responses to public health crisis events includes decoding the genome of the SARS virus in 2003 and developing the virus detection kit in 96 hours, and helping fight the Ebola outbreak in 2014 in West Africa, where BGI quickly set up a front-line laboratory in Sierra Leone and helped the local team to develop Ebola virus detection kits.

About EUA

The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV has not been FDA cleared or approved. However, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition, as in the case of the novel coronavirus when the secretary of the U.S. Department of Health and Human Services (HHS) declares a public health emergency. HHS Secretary Alex Azar declared an emergency for COVID-19 on January 31. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About BGI Genomics Co Ltd.

BGIwas founded in 1999 with the vision of using genomics to benefit humanity and has since become one of the largest genomics organizations in the world. With a focus on research and applications in the healthcare, pharmaceutical, conservation and environmental fields, BGI has a proven track record of innovative, high-profile research that has generated over 1,600 publications. BGI Genomics is an independent division of BGI Group and was listed on theShenzhen Chi-Next exchange inJuly 2017. BGI Genomics' goal is to make state-of-the-art genomics highly accessible to the global research community and clinical markets by integrating the industry's broadest array of leading technologies, including BGI's own DNBSEQ technology platforms, economies of scale, and expert bioinformatics resources. BGI Genomics also offers a wide portfolio of transformative genetic testing products across major diseases, enabling medical providers and patients worldwide to realize the promise of genomics-based diagnostics and personalized healthcare.

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SOURCE BGI

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BGI's RT-PCR SARS-CoV-2 Test to Detect Novel Coronavirus Now Commercially Available for Clinical Use in the United States - Yahoo Finance

Recommendation and review posted by Bethany Smith

DUBLIN, March 18, 2020 /PRNewswire/ -- The "US Female Infertility Diagnosis And Treatment Market 2019-2025" report has been added to ResearchAndMarkets.com's offering.

The US female infertility diagnosis and treatment market is expected to witness a significant growth with the CAGR of 3.8% during the forecast period.

The US Female infertility diagnosis and treatment diagnosis and treatment market is growing significantly due to various factors such as increasing infertility rate among females, unhealthy lifestyle and development of new technologies in IVF treatment. Apart from these factors, the rising trend of surrogacy in the country is also driving the growth of the market. According to the American Pregnancy Association in 2017, infertility affects around 6 million American couples, which corresponds to around 10% of American females of childbearing age. In addition, around 25% of infertile couples have more than one cause of infertility. The growing infertility rate creates the demand for infertility diagnosis and treatment, which in turn, drives the market growth.

The US Female infertility diagnosis and treatment market is segmented on the basis of diagnosis, treatment type, and end-user. Based on the diagnosis, the market is segmented into ovulation testing, hysterosalpingography (HSG), hysteroscopy, imaging testing, ovarian reserve testing, hormonal level testing, genetic testing, and others (laparoscopy). Based on the treatment type, the market is segmented into drugs, surgery, intrauterine insemination (IUI), and assisted reproductive technology (ART). Based on the end-user, the market is segmented into hospitals and clinics, homecare, and pathology and diagnostic center.

Some of the major players operating in the US female infertility diagnosis and treatment market include Abbott Laboratories, Inc., Merck KGaA, Cipla Ltd., and others. These players adopt various organic and inorganic growth strategies such as merger and acquisition and product launch to strengthen their presence in The US market.

The report covers:

Key Topics Covered

1. Report Summary1.1. Research Methods and Tools1.2. Market Breakdown1.2.1. By Segments

2. Market Overview and Insights2.1. Scope of the Report2.2. Analyst Insight& Current Market Trends2.2.1. Key Findings2.2.2. Recommendations2.2.3. Conclusion2.3. Rules & Regulations

3. Competitive Landscape3.1. Company Share Analysis3.2. Key Strategy Analysis3.3. Key Company Analysis

4. Market Determinants4.1. Motivators4.2. Restraints4.3. Opportunities

5. Market Segmentation5.1. The US Female Infertility Diagnosis and Treatment Market by Diagnosis5.1.1. Ovulation Testing5.1.2. Hysterosalpingography (HSG)5.1.3. Hysteroscopy5.1.4. Imaging Testing5.1.5. Ovarian Reserve Testing5.1.6. Hormonal Level Testing5.1.7. Genetic Testing5.1.8. Others (Laparoscopy)5.2. The US Female Infertility Diagnosis and Treatment Market by Treatment5.2.1. Drugs5.2.2. Surgery5.2.3. Intrauterine Insemination (IUI)5.2.4. Assisted Reproductive Technology (ART)5.3. The US Female Infertility Diagnosis and Treatment Market by End-User5.3.1. Hospitals and Clinics5.3.2. Homecare5.3.3. Pathology and Diagnostic Centers

6. Company Profiles6.1. Church & Dwight Co.6.2. Cook Group Inc.6.3. Eli Lilly Co.6.4. Fairhaven Health, LLC6.5. FUJIFILM Irvine Scientific, Inc.6.6. Millendo Therapeutics, Inc.6.7. Pfizer Inc.6.8. Princeton BioMeditech Corp6.9. Bayer AG6.10. Church & Dwight Co. Inc.6.11. Vitrolife6.12. Cook Medical, Inc.6.13. Eli Lilly & Co.

For more information about this report visit https://www.researchandmarkets.com/r/ujkft2

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Research and Markets Laura Wood, Senior Manager [emailprotected]

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The US Female Infertility Diagnosis & Treatment Market to 2025 - Contains End-user Insights for Hospitals & Clinics, Homecare, and Pathology...

Recommendation and review posted by Bethany Smith

ROCKLAND, Mass. and NEW YORK, March 13, 2020 /PRNewswire/ --EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE)today announced an update from the Phase III JAVELIN Head and Neck 100 study evaluating avelumab in addition to chemoradiotherapy (CRT) versus standard-of-care CRT in patients with untreated locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).The alliance has accepted the recommendation of the independent Data Monitoring Committee (DMC) to terminate the JAVELIN Head and Neck 100 trial, as the study is unlikely to show a statistically significant improvement in the primary endpoint of progression-free survival (PFS) based on a preplanned interim analysis. A detailed analysis of the Phase III JAVELIN Head and Neck 100 study is being conducted and study findings will be shared with the scientific community.

There has been limited innovation for patients with locally advanced SCCHN over the past 10 years.1 Despite aggressive standard-of-care treatment with high-dose chemotherapy combined with radiotherapy, LA SCCHN will ultimately recur in a large proportion of patients.2 In recognition of the unmet need for additional treatment options that can prevent recurrence or metastatic disease,3 the alliance initiated the JAVELIN Head and Neck 100 trial, which is the first Phase III study to report topline results for an immune checkpoint inhibitor in combination with CRT in LA SCCHN.

About JAVELIN Head and Neck 100 JAVELIN Headand Neck 100 (NCT02952586) is a Phase III, randomized, double-blind, placebo-controlled, parallel-arm study investigating treatment with avelumab plus standard-of-care CRT followed by avelumab maintenance versus CRT alone in patients with previously untreated LA SCCHN. A total of 697 patients who had not received prior therapy for locally advanced SCCHN and were eligible for CRT with curative intent were randomly assigned to receive avelumab plus CRT or CRT alone. The primary endpoint was PFS per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary endpoints included overall survival (OS), time to locoregional failure, time to distant metastatic failure, overall response, duration of response and pathologic complete response.

About Head and Neck CancerHead and neck cancer is the sixth most common cancer worldwide.4 In 2016, there were nearly 150,000 newly diagnosed cases in the United States, Japan and Europe.4Approximately 60% of people are diagnosed with head and neck cancer when their disease has already progressed to the locally advanced stage (Stage III-IVB).5 At this stage, the cancer has spread from its site of origin to local lymph nodes, but not another part of the body.6 Standard of care for these patients includes high-dose chemotherapy combined with radiotherapy.7

About BAVENCIO (avelumab)BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.8-10 In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications BAVENCIO (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Important Safety Information from the US FDA-Approved LabelBAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barr syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinib can cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACEoccurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, 20%) in patients with locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%), and urinary tract infection (21%).

Selected laboratory abnormalities (Grades 3-4, 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

Fatal adverse reactions occurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, 20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, 20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.

About Merck KGaA, Darmstadt, Germany-Pfizer AllianceImmuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany and Pfizer. The global strategic alliance between Merck KGaA, Darmstadt, Germany and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of BAVENCIO, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance is jointly developing and commercializing BAVENCIO. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to http://www.emdgroup.com/subscribe to register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About EMD Serono, Inc.EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt,Germany, in the U.S. andCanada- is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state ofMassachusetts.www.emdserono.com.

About Merck KGaA, Darmstadt, GermanyMerck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany, generated sales of 16.2 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Pfizer Inc.: Breakthroughs that change patients' livesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com.In addition, to learn more, please visit us on http://www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure NoticeThe information contained in this release is as of March 13, 2020. Pfizer assumes no obligation to update forward-looking statementscontained in this release as the result of new information or future events or developments.

This release contains forward-looking information about BAVENCIO (avelumab), the alliance between Merck KGaA, Darmstadt, Germany,and Pfizer involving BAVENCIO and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and whenany drug applications may be filed in any jurisdictions for any potential indications for BAVENCIO or combination therapies; whether and when regulatory authorities in any jurisdictions where any applications are pending or may be submitted for BAVENCIO or combination therapies may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy, and, if approved, whether they will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BAVENCIO; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

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EMD Serono and Pfizer Provide Update on Phase III JAVELIN Head and Neck 100 Study - P&T Community

Recommendation and review posted by Bethany Smith

The Scorpion HMD is just one facet of what is turning out to be one potent and efficient aggressor jet. The six fully configured F-5ATs Tactical Air now has on strength also sport the multi-mode Nemesis pulse-doppler radar from Duotech. This system takes up the majority of the jet's nose, with the guns having been removed. The radar is designed specifically for the adversary mission and is fully fused with the aircraft's Garmin 3000 avionics suite.

Nemesis is superior in range to the AN/APG-66 radar that is found in a competitor's A-4s and in older F-16s, some of which are going to be joining the private aggressor industry, and has the ability to simulate various enemy radars and missile systems. It is also designed for extreme reliability and has the potential to have its mechanically scanned array (MESA) antenna to be converted to a more capable active electronically scanned array (AESA) antenna in the future.

Duotech is also supplying the radar warning receiver suite for the F-5AT, which provides a high degree of passive situational awareness. The system, dubbed Argus, can be easily integrated onto certain aircraft, like the F-5, using existing apertures and has 360 degree, wideband threat detection capability.

The jets are also set to receive a proprietary data-link that will allow them to share information freely among themselves, including targeting and weapons data, and it will support secure communications. This could be extremely useful if an AESA radar gets installed in some of the company's F-5ATs. With the data-link, just one jet equipped with a more advanced radar could share all its information with other F-5ATs, making it a big force multiplier. Currently, the air combat maneuvering instrumentation (ACMI) pod the F-5ATs carry, the Cubic's P5 model, offers limited aircraft-to-aircraft data-link capabilities, including the sharing of position data, which is highly useful for the aggressor role.

These features are in addition to the airframes being overhauled by Northrop Grumman and the Garmin 3000 large panel display glass cockpit being installed, as well as hands-on throttle and stick controls, and other enhancements.

The software that runs on the Garmin system and handles data-fusion and tactical information was also developed specifically for the aggressor mission. It's called Venom and comes from L3Harris.

In a press release, L3Harris described Venom as such:

"Venom integrates the latest air-to-air capabilities using commercial off-the-shelf components, providing pilots desired look, feel and operation in the cockpit. The suite enables third-generation platforms to operate as a fifth-generation platform, and more realistically emulate modern adversaries.

The Venom suite continues L3Harris work in adversary mission systems by integrating a high-resolution tactical situation display, presenting radar and datalink track information, threats, system status and weapons engagement information with the Garmin G3000 Integrated Flight Deck touch controller and bezel key interfaces. This provides pilots an intuitive, cutting-edge capability for performing adversary training missions. Scaleable, reconfigurable and adaptable, Venom enables platforms to maintain relevance by easily and affordably incorporating new or desired adversary capabilities."

Guthals noted just how reliable the F-5AT configuration is. Four jets now operating out of Fallon accomplished three sorties each on a single day last week. That's impressive reliability by today's tactical fast jet standards.

Clearly, the Navy has taken notice as to what Tactical Air has accomplished with the F-5AT conversion and is looking at doing something very similar to its own comparatively antiquated F-5Ns, of which the service is buying more second-hand from Switzerland. Tactical Air is actually helping to manage that upgrade program for the Navy, so it is very likely that a similar, if not nearly identical configuration will eventually find its way into the Navy two F-5 equipped aggressor squadronsVFC-13 and VFC-111and the Marine's single F-5 aggressor unitVMFT-401.

As for the longevity of Tactical Air's 'super Tiger IIs' of sorts, they came from surplus Jordanian stocks and apparently had very low flight time to begin with, with around 2,000 hours on each of them. Guthals notes that the F-5s are good for roughly 7,000 hours as originally designed and can go significantly beyond that with a service life extension.

All told, it is fairly remarkably what Tactical Air has achieved with its F-5TA initiative. The little planes pack an incredible amount of current-day tech that is specifically designed for aggressor operations, not repurposed from combat applications, into highly reliable, proven, efficient, and enduring design. The Navy also gets to take advantage of its development work by upgrading its own F-5s, which remain the backbone of the Navy and Marine Corps' aggressor force.

The Navy passed over another aggressor company that proposed using the F-16 platform for the NAS Fallon contract due to Tactical Air's efficient plan. Time will tell just how good of a decision that was, but as it sits now, Navy pilots are facing an enhanced F-5 adversary that is better adapted to the aggressor mission than ever before and Air Force pilots are likely to be slugging it out with the F-5AT soon, as well.

Contact the author: Tyler@thedrive.com

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Private Aggressor F-5 Fighter Force Is Flying With Helmet Mounted Displays - The Drive

Recommendation and review posted by Bethany Smith

AMSTERDAM, The Netherlands, March 17, 2020 (GLOBE NEWSWIRE) -- Share Natur International Corp., (OTCQB:NTRU), a "farm-to-functional" producer of natural and organic plant-based foods and beverages including full and broad spectrum CBD (cannabinoid) and terpene-blended consumer products, today announced that Dr. Nina Storms has resigned from the company's Board of Directors for personal reasons, effective February 21. The Board has voted to appoint Karen Brink to the position, effective immediately.

Dr. Storms is the visionary behind the present strategy of Share Natur International.

Commenting on her resignation, Dr. Storms said, "I believe that this is the right moment for me to resign from the Share Natur board. This change stems from personal reasons, but also importantly, my seat will now be filled with someone from a younger generation, my daughter Karen Brink, who can contribute as the company continues working to secure a leading market position. I have been fortunate to work with my esteemed board members, all of us have worked closely together to ensure the success of Share Natur. I am very thankful for this great opportunity."

Spencer Chesman, CEO of Share Natur International, commented, "I have become quite close to Nina and her family and truly appreciate all of her efforts in positioning Share Natur in the ever expanding health and wellness business arena. Nina has a vast network and is knowledgeable in corporate environments and strategy, and I am sure she will continue to maintain these contacts to the benefit of Share Natur. I understand her motivation to resign from the constraints that a board seat can bring and I look forward to her continued support. Her contribution to the company in concert with the other board members has been selfless and the company has benefited tremendously, we will miss her everyday guidance."

Karen Brink added, "I am honored to assume a seat on the Board of Directors of Share Natur. I have worked in the company for some time now and strongly believe in its potential, direction and strategy. I understand my mother's motivation to leave the board at this time and am grateful to have learned so much from her as we worked together on many projects during the last few years."

Li Zeng, a member of the Share Natur International Executive Management Team, stated, "I have been very privileged to work and learn from Nina. Uniquely, she was able to understand, absorb and integrate the Chinese culture and mannerisms, unlike many others, with those of Share Natur, which has a more western approach. As one of the Chairmen of CQ News, the second largest media station in China, I look forward to Nina's continued support and advice."

About Share Natur International Corp.

Share Natur, founded in 2015 to market "farm-to-functional" natural and organic plant-based foods and beverages, expanded its product portfolio this past year to include full and broad spectrum CBD (cannabinoid) and terpene-blended consumer products. With the portfolio expansion, Share Natur is moving swiftly to place relevant consumer goods in multiple health and wellness categories including food and beverage, snacks, health and beauty, supplements, sports and animal care. Share Natur personalizes nutrition and strives to enhance one's quality of life by utilizing the forces of nature, driven by science.

Share Natur applies the most advanced and emerging hi-tech health methodologies as it markets nutritious, delicious and fresh-tasting products. By applying innovative technologies to the breeding of its plant sources, the extraction of its ingredients, and delicate shelf life extension, Share Natur ensures the peak of freshness, and supplies nutrient-dense products that are superior to competitors' offerings. The company remains astute to relevant "snackification" trends and goes to market through Europe's leading retailers, foodservice partners and online eCommerce subscription models. For additional information, please visit http://www.int.natur.eu.

Forward-Looking Statements

All statements in this release that are not based on historical fact are "forward-looking statements." While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties, some of which are described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our Annual Report on Form 10-K, which can be found on the SEC's website at http://www.sec.gov. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

Contacts:

PCG Advisory Inc.Jeff Ramson+16467624518jramson@pcgadvisory.comOrLaurens FelderhofCMO, Share Natur+31639262609ir@natur.eu

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Share Natur International Announces Resignation of Dr. Nina Storms, Founder and Company Visionary, from Board of Directors - Benzinga

Recommendation and review posted by Bethany Smith

Gene therapy could dramatically alter how dozens of inherited diseases are treated. It's also transforming how the academic institutions working in this growing field move research from the laboratory to the clinic.

Private sector skepticism a decade or more ago spurred institutions like the University of Pennsylvania and Nationwide Children's Hospital to advance experimental projects much further before selling their ideas to biopharma companies a departure from the previous model of identifying a molecular target and letting industry do the heavy lifting.

As a result, university technology transfer officers are much more involved in the technical and commercial details of preclinical drug development, from assembling financing and creating private companies to building manufacturing capacity. The product is a host of new startups, such as AveXis, Spark Therapeutics and Bamboo Therapeutics, that in recent years have been swallowed up by large pharmaceutical companies.

"The old way is, 'I have a patent, I'm going to throw it over the fence to you and you throw me a sack of money,'" said John Swartley, managing director of the University of Pennsylvania's Penn Center for Innovation, in an interview. "This is completely different. This is co-development."

John Swartley

Permission granted by University of Pennsylvania

"We're directly involved over multiple years in helping to move the technology forward. And our commercialization partner is going to take it hopefully all the way to the market."

A paper published earlier this month in JAMA quantifies the shift. Together, hospitals, universities and the National Institutes of Health sponsored 206 of the 341 identified gene therapy trials that were active in 2019. Biotech and pharma companies led the remaining 135.

Measured by funding, hospitals, universities and the NIH had a hand in more than 280 of those studies, as some trials had multiple funders. Fourteen trials were funded by other federal sources or non-profit charities.

Hospitals and universities were most active in early-stage studies, with industry sponsoring only 22% of Phase 1 trials. But, in gene therapy, those initial human tests can hold more weight, as the benefits of a genetic fix can be quickly apparent.

"This is a sign that the model of drug development that was prominent in the past academia does basic science and finds some targets and then pharma develops the actual drug product is pretty different with gene therapy," one of the paper's authors, Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, wrote in an email to BioPharma Dive.

The changing academic model also raises questions about the rich price tags being sought by drugmakers for gene therapies, given the greater role played by universities and other non-profit entities.

"The paper, I think, informs discussions about how high prices really need to be in order to encourage private risk taking for gene therapies it may be a different number than for other drugs that have less late stage involvement by academia and NIH," wrote Gellad.

University involvement in gene therapy development was driven in part by the private sector's reluctance to get involved in a therapeutic approach perceived, until several years ago, as risky. The death of Jesse Gelsinger in a Penn gene therapy trial in 1999 inflicted severe reputational damage on the field, driving away drugmaker interest.

Scientists kept the faith, and their institutions carried the field forward for years afterward. When Swartley began working at Penn in 2007, one of his first meetings was with the university's gene therapy director James Wilson, who was in charge of the tragic trial that led to Gelsinger's death.

James Wilson

Permission granted by the University of Pennsylvania

"From an external perspective, from an industrial perspective, there was almost nothing happening," he said. "But it was evident from the kind of research that Dr. Wilson and his colleagues were sharing with us, they made a very convincing case that this was going to rapidly shift into a more of a developmental paradigm."

"They were anticipating a tremendous amount of industry interest when that shift occurred," Swartley added. "It turned out to be very prophetic."

At the University of North Carolina, the situation was similar in the early part of the 2000s. The institution reached a slightly different solution, however, spinning out companies like Asklepios BioPharmaceutical to advance gene therapy beyond the walls of the university laboratories.

"We had a lot of vector technology, but the market was not receptive to gene therapy at the time," said Kelly Parsons, associate technology commercialization director at UNC, in an interview. "We had a startup company that had to work very diligently to try to establish the merits of gene therapy."

Asklepios is still an independent company today, some of its gene therapy work having been folded into a Pfizer-owned Duchenne muscular dystrophy project that was previously developed by Bamboo Therapeutics.

But the time spent building the knowledge and expertise at universities or closely affiliated startups has been one of the reasons why big pharmas have rushed into the space. By advancing the technology, the universities reduced the risk of failure, making pharmas more willing to buy in.

"We had a recognition that if we wanted the for-profit sector and the investment sector and the [venture capital] world to give gene therapy a chance, it was important as an institution we were able to start that process of de-risking the asset," said Matthew McFarland, vice president of commercialization and industry relations at Nationwide, in an interview.

Doing so was a greater commitment than they expected. "What we did is say: 'What stage would these assets need to get to before external dollars would be interested in investing?'" he said. "And the reality is, oh my gosh, you have to de-risk it all the way to the point it's ready to go into the patients."

That included the initial Phase 1 study of the spinal muscular atrophy gene therapy now known as Zolgensma, which was licensed to AveXis and later acquired by Novartis.

More broadly, development included building production capabilities compliant with Good Manufacturing Practices, which govern quality and consistency standards for finished drug products, and a regulatory team that was able to prepare Investigational New Drug applications within the hospital's technology transfer office.

Building up manufacturing expertise has resulted in a new business for Nationwide: the for-profit Andelyn Biosciences, which will run a commercial scale gene therapy production facility.

Solving the manufacturing question is something many academic gene therapy centers are still grappling with as they near the point of handing off to private-sector partners. Biopharma companies want to have confidence that the therapies manufactured by university scientists will work as well in clinical trials and in wider use as they did in earlier study.

"There's no university that has the ability to ramp their early production manufacturing production to a level to get enough doses that industry doesn't have to recapitulate it," said Jim O'Connell, director of technology transfer at the University of Florida's UF Innovate, in an interview. "It's notorious for university labs, small molecules and others, to not be able to have their work reproduced out in the real world."

This very question may have been behind data quality issues for Zolgensma. Last summer, Novartis was chastised by the Food and Drug Administration for having submitted manipulated preclinical data, a scandal that the Swiss pharma tied to AveXis co-founder and former Nationwide trial investigator Brian Kaspar. Through his lawyer, Kaspar has denied all wrongdoing.

"Academic institutions have got to ask themselves: How far into this do we want to go?," said O'Connell. "It's going to have a whole bunch of costs that universities aren't used to taking on. How do we share the expense? How do we share the risk appropriately?"

Thorny questions notwithstanding, the increased investment has led to better returns for universities. Technology transfer offices interviewed by BioPharma Dive report the licensing deals are much richer for gene therapies that have advanced to human testing or near it money which gets returned to scientists and their departments to fund new research.

Returns aren't equally shared, however. Schools blessed with research that is sought-after by private industry flourish, while others struggle, said Lee Vinsel, a Virginia Tech assistant professor who is writing a book called "The Innovator's Delusion."

Indeed, broadly speaking, universities reported a little more than $3 billion in licensing revenue in 2017, but spent $68 billion, according to the Association of University Technology Managers. Less than 1% of licenses yielded more than $1 million in revenue.

Moreover, Vinsel argues the potential for licensing revenue incentivizes universities to only conduct research the private sector wants to license.

"One reason why we need federal funding and university research is to do basic science that corporations aren't going to pay for and do," Vinsel said. "If we tack more university research towards the profitable, who is going to do this basic work, including research that could really help society but will enrich no one?"

McFarland of Nationwide, however, points to less lucrative licenses it has signed, such as a device to prevent pressure ulcers in patients with tracheostomies, along with a mental health research and treatment facility the institution has launched, as ventures that were enabled by bigger deals like in gene therapy.

"If we can take that return and continue to foster research not only in [gene therapy] but even further spread that out and have an impact across all of research," he said.

"There are a lot of times when we're not the office of tech commercialization, but instead we're the office of tech realization, because what we go into is just about getting it out there to the public, and we're not going to get a return on it."

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Big pharma shied away from gene therapy for years. Academia picked up the slack - BioPharma Dive

Recommendation and review posted by Bethany Smith

Revenue from marketed dermatology products increased 85% for fourth quarter 2019 and 49% for full-year 2019 compared to 2018

NDA for IV tramadol accepted for review by FDA; PDUFA date is set for October 10, 2020

Rolling NDA submission for CUTX-101 for the treatment of Menkes disease is on track to begin in the fourth quarter of 2020

NEW YORK, March 16, 2020 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (Fortress), an innovative biopharmaceutical company, today announced financial results and recent corporate highlights for the fourth quarter and full year ended December 31, 2019.

Fortress achieved multiple key milestones in 2019 and early 2020, including:

Lindsay A. Rosenwald, M.D., Fortress Chairman, President and Chief Executive Officer, said, We have generated significant momentum throughout 2019 and into early 2020. In order to drive our next phase of growth, our world-class business development team continues to identify and acquire high-potential marketed and development-stage assets to further expand our portfolio of product opportunities. Additionally, Fortress and our development partners continue to advance our clinical-stage programs across multiple therapeutic categories. With five commercial products and over 25 programs in development, we aim to continue to meaningfully increase value and decrease overall risk for Fortress shareholders. Looking ahead, we expect 2020 to be a record revenue-generating year and a transformational one for many of the development-stage programs across Fortress and our partner companies. Finally, we look forward to continued acquisitions of marketable dermatology drugs and in-licenses of development-stage drug candidates.

2019 and Recent Corporate Highlights1:Marketed Dermatology Products

IV Tramadol

CUTX-101

CAEL-101

MB-107 (Lentiviral Gene Therapy for XSCID)

Cosibelimab (formerly CK-301, an anti-PD-L1 antibody)

CK-101 (third-generation EGFR inhibitor)

MB-102 (CD123-targeted CAR T cell therapy)

MB-101 (IL13R2-targeted CAR T cell therapy)

MB-108 (Oncolytic Virus C134)

MB-104 (CS1-targeted CAR T cell therapy)

MB-103 (HER2-targeted CAR T cell therapy)

MB-105 (Prostate Stem Cell Antigen (PSCA)-targeted CAR T cell therapy)

MB-106 (CD20-targeted CAR T cell therapy)

BAER-101 (novel 2/3subtype-selective GABA A positive allosteric modulator [PAM])

General Corporate

Financial Results:

About Fortress Biotech Fortress Biotech, Inc. (Fortress) is an innovative biopharmaceutical company that was recently ranked number 10 in Deloittes 2019 Technology Fast 500, an annual ranking of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentage of fiscal year revenue growth over a three-year period. Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has five marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market therapeutic areas, including oncology, rare diseases and gene therapy, which allow it to create value while mitigating risk for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the companys portfolio of product opportunities. Fortress has established partnerships with some of the worlds leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., City of Hope, Fred Hutchinson Cancer Research Center, InvaGen Pharmaceuticals Inc. (a subsidiary of Cipla Limited), St. Jude Childrens Research Hospital and Nationwide Childrens Hospital. For more information, visit http://www.fortressbiotech.com.

Forward-Looking StatementsThis press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words we, us and our may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on managements current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; our dependence on third-party suppliers; risks relating to the COVID-19 outbreak and its potential impact on our employees and consultants ability to complete work in a timely manner and on our ability to obtain additional financing on favorable terms or at all; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Company Contacts:Jaclyn Jaffe and William BegienFortress Biotech, Inc.(781) 652-4500ir@fortressbiotech.com

Investor Relations Contact:Daniel FerryLifeSci Advisors, LLC(617) 430-7576daniel@lifesciadvisors.com

Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com

____________________________________________1 Includes product candidates in development at Fortress, majority-owned and controlled partners and partners in which Fortress holds significant minority ownership positions. As used herein, the words we, us and our may refer to Fortress individually or together with our affiliates and partners, as dictated by context.

FORTRESS BIOTECH, INC. AND SUBSIDIARIESConsolidated Balance Sheets($ in thousands except for share and per share amounts)

FORTRESS BIOTECH, INC. AND SUBSIDIARIESConsolidated Statements of Operations($ in thousands except for share and per share amounts)

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Fortress Biotech Reports Record Fourth Quarter and Full-Year 2019 Financial Results and Recent Corporate Highlights - BioSpace

Recommendation and review posted by Bethany Smith

Global Cancer Gene Therapy Report available at Digits n Markets contains an overview of the Global Cancer Gene Therapy which covers market size, opportunities, trends, growth rate, and competition landscape. The Global Cancer Gene Therapy is segmented Source, Product Type Applications and regions. With forecast to 2027.

Digits n Markets has recently published a comprehensive market research report on the Global Cancer Gene Therapy that includes evaluation of market size and various segments. The competitive environment is analyzed along with study of winning strategies adopted by key players.

The report is a detailed study on the accounting Global Cancer Gene Therapy with details regarding an in-depth evaluation of the industry vertical. The study is performed taking into consideration a twofold aspect of consumption and production. Speaking of the product category, the report provides detailed product remuneration, manufacturing of the product and the gross margins of the firms manufacturing the products. With regards to the consumption, the study reveals the product consumption value and the product consumption volume along with the status of import as well as the export of the products.

The Global Cancer Gene Therapy Market Anticipated to exhibit a CAGR 35.1% during Forecast Period. 2018-2025

Avail a free sample in PDF format along with a quick look at vital report briefs:https://digitsnmarkets.com/sample/6650-global-cancer-gene-therapy-market

Key Questions Answered by the Report:

Numerous micro and macro-economic factors impacting the growth of the market are analyzed and the data is represented in a way to aid the clients to enhance their strategic decision making. Key players operating in the Global Cancer Gene Therapy are:

Table of Content

Chapter 1: IntroductionChapter 2: Executive SummaryChapter 3: Market OverviewChapter 4: Cancer Gene Therapy Market, By TypeChapter 5: Cancer Gene Therapy Market, By ApplicationChapter 6: Cancer Gene Therapy Market, By RegionChapter 7: Competition Landscape

Originally posted here:
Global Cancer Gene Therapy Market, Trends, Analysis, Opportunities, Share and Forecast 2018-2025 - Galus Australis

Recommendation and review posted by Bethany Smith

SAN DIEGO and PENNINGTON, N.J., March 17, 2020 /PRNewswire/ --OncoSec Medical Inc. Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, today announced the publication of positive TAVO monotherapy data in patients with metastatic melanoma in the Annals of Oncology. The publication titled, "Intratumoral Delivery of Tavokinogene Telseplasmid Yields Systemic Immune Responses in Metastatic Melanoma Patients," features data previously highlighted at both American Association of Cancer Research (AACR) and the Melanoma Bridge annual meetings.Annals of Oncologyis the official publication of the European Society for Medical Oncology.

The complete publication in Annals of Oncology is linked here and available on OncoSec's website at https://oncosec.com/publications/.

The publication describes OncoSec's study of patients with Stage III/IV melanoma who were treated intratumorally with plasmid encoding IL-12 (tavokinogene telseplasmid or TAVO), followed by electroporation on days 1, 5, and 8 every 90 days in the main study with additional patients treated in two exploration cohorts with alternative schedules. Correlative analyses for programmed death-ligand 1 (PD-L1), flow cytometry to assess changes in immune cell subsets and analysis of intratumoral immune-related gene expression were carried out on pre-and post-treatment samples from study patients, as well as from additional patients treated during exploration of additional dosing schedules beyond the pre-specified protocol dosing schedule.Response was measured by study-specific criteria to maximize detection of latent and potentially transient immune responses in patients with multiple skin lesions.Toxicities were graded by the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).

The objective overall response rate (ORR) was 35.7% in the main study, with a complete response (CR) rate of 17.9%.The median progression-free survival in the main study was 3.7 months while the median overall survival was not reached at a median follow up of 29.7 months. A total of 46% of patients in all cohorts having both injected and uninjected lesions experienced regression of at least one of these uninjected lesions and 25% had a net regression of all untreated lesions. Transient procedural pain (n= 24, 80%) and injection site reactions were the most commonly experienced adverse events.

Transcriptomic and immunohistochemistry analysis showed that immune activation and co-stimulatory transcripts were up-regulated, with an increase of adaptive immune resistance.

The publication concluded that intratumoral TAVO was well-tolerated and led to systemic immune responses in advanced melanoma patients. While tumor regression and increased immune infiltration were observed in treated as well as untreated/distal lesions, adaptive immune resistance limited the response.

"TAVO treatment appears to drive a change in the immune microenvironment, which results in an immune response to melanoma with minimal systemic toxicity. These data demonstrate that thisin situtumor vaccination strategy may be a safe and effective approach to inducing multiple sustained, productive changes in the immune microenvironment that would be too toxic using similar systemic agents and drive significant clinical results," concluded study co-author Adil Daud, M.D., Department of Medicine, University of California, San Francisco."We look forward to continued evaluation of the TAVO approach as a monotherapy in future clinical trials."

TAVOis currently being evaluated as a combination therapy in multiple clinical trials, including KEYNOTE-695, a pivotal trial in late-stage anti-PD-1 checkpoint refractory metastatic melanoma, and two phase 2 trials, one for triple negative breast cancer (TNBC) and a second for head and neck cancer. TAVO enables the intratumoral delivery of DNA-based IL-12, a naturally occurring protein with immune-stimulating functions.OncoSec's technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body.Results from recently completed clinical studies of TAVOhave demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach.

"While our ongoing pivotal KEYNOTE-695 study is evaluating TAVO and KEYTRUDA combination therapy in late-stage checkpoint refractory metastatic melanoma patients and has begun to yield positive results, publication of monotherapy data with TAVO demonstrates its utility as a standalone treatment in this patient population," stated Christopher Twitty, Ph.D., OncoSec's Chief Science Officer and a co-author of the publication. "The increase in adaptive resistance observed in the tumor microenvironment, in particular PD-L1, makes TAVO a particularly well-suited partner with anti-PD-1 checkpoint therapies.We are encouraged to see such a high response rate and will continue to evaluate TAVO's utility as a monotherapy for metastatic melanoma."

Annals of Oncology is the latest among a presently growing volume of peer-reviewed journals to highlight the potential of TAVO as a novel immunotherapy. A recent publication in Cancer Immunology Research, linked here, also explored the mechanism of activation of systemic immunity in patients from the TAVO monotherapy study in metastatic melanoma patients. Additionally, Clinical Cancer Research featured TAVO monotherapy data in Merkel cell carcinoma on the cover of its February 2020 issue, linked here. You can find a list of all TAVO publications and scientific presentations at https://oncosec.com/publications/.

About OncoSec Medical IncorporatedOncoSec Medical Incorporated (the "Company," "OncoSec," "we" or "our") is a late-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec's lead immunotherapy investigational product candidate TAVO (tavokinogene telseplasmid) enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions.The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVOas a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders.Results from recently completed clinical studies of TAVOhave demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach. In addition to TAVO, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visit http://www.oncosec.com.

TAVOis a trademark of OncoSec Medical Incorporated.

KEYTRUDAis a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Risk Factors and Forward-Looking Statements This release, as well as other information provided from time to time by the Company or its employees, may contain forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Forward-looking statements provide the Company's current beliefs, expectations and intentions regarding future events and involve risks, uncertainties (some of which are beyond the Company's control) and assumptions. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "should," "will" and "would" and similar expressions (including the negative of these terms). Although we believe that expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. The Company intends these forward-looking statements to speak only at the time they are published on or as otherwise specified, and does not undertake to update or revise these statements as more information becomes available, except as required under federal securities laws and the rules and regulations of the Securities Exchange Commission ("SEC"). In particular, you should be aware that the success and timing of our clinical trials, including safety and efficacy of our product candidates, patient accrual, unexpected or expected safety events, and the usability of data generated from our trials may differ and may not meet our estimated timelines. Please refer to the risk factors and other cautionary statements provided in the Company's Annual Report on Form 10-K for the fiscal year ended July 31, 2019 and subsequent periodic and current reports filed with the SEC (each of which can be found at the SEC's websitewww.sec.gov), as well as other factors described from time to time in the Company's filings with the SEC.

Company Contact:Gem HopkinsHead of Corporate Communications858-210-7334ghopkins@oncosec.com

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SOURCE OncoSec Medical Incorporated

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OncoSec Announces Publication of Positive TAVO Monotherapy Results in Metastatic Melanoma Patients in Annals of Oncology - BioSpace

Recommendation and review posted by Bethany Smith

Xiaoyu Xia,1,* Li Wang,1,* Xiao Yang,2 Yanqin Hu,1 Qiang Liu1

1Shanghai Key Laboratory of Reproductive Medicine, Department of Histoembryology, Genetics and Developmental Biology, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, Peoples Republic of China; 2Shanghai Key Laboratory of Orthopedic Implants, Department of Orthopedics, Ninth Peoples Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, Peoples Republic of China

*These authors contributed equally to this work

Correspondence: Qiang LiuDepartment of Histoembryology, Genetics and Developmental Biology, Shanghai Jiao Tong University School of Medicine, 280 South Chongqing Road, Shanghai 200025, Peoples Republic of ChinaTel +86 21 63846590 Ext. 776761Email qliu0122@shsmu.edu.cn

Background: Curcumin has shown many pharmacological activities in both preclinical and clinical studies. Many technologies have been developed and applied to improve the solubility and bioavailability of curcumin, especially the nanotechnology-based delivery systems. However, there has been evidence that certain nanoparticles have potential reproductive toxicity in practice.Methods: Curcumin-poly (lactic-co-glycolic acid) (PLGA)-PEG nanoparticles (Cur-PLGA-NPs for short) were prepared. The Cur-PLGA-NPs were evaluated with its effect on the proliferation of mouse testicular cell lines in vitro and spermatogenesis in vivo, while PLGA-NPs were used as control. For animal experiments, male BALB/c mice were treated with 20 mg/kg of Cur-PLGA-NPs for continuous 10 days via tail vein injection.Results: We found the curcumin nanoparticles suppressed the proliferation of testicular cell lines in vitro. Furthermore, a short-term intravenous delivery of curcumin-loaded nanoparticles could be harmful to the differentiation of spermatogonia, the elongation of spermatids, as well as the motility of mature sperms.Conclusion: In the present study, we disclosed the acute damage on mouse spermatogenesis and sperm parameters by curcumin-loaded nanoparticles. Our results suggested that the reproductive toxicity of nanoformulated curcumin needs to be prudently evaluated before its application.

Keywords: nano-curcumin, reproductive toxicity, Sertoli cell, sperm motility, spermatogenesis

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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Acute Damage to the Sperm Quality and Spermatogenesis in Male Mice Exp | IJN - Dove Medical Press

Recommendation and review posted by Bethany Smith

Males that face tougher competition for females risk having offspring with a greater number of harmful mutations in their genome than males without rivals. Researchers at Uppsala University have discovered this correlation in the beetle species Callosobruchus maculatus.

Many researchers working in the fields of human reproductive biology and more general evolutionary theory have taken an interest in this. The hypothesis is not new in itself but there have been few experiments conducted to test it. This is where we hope our study can contribute an important piece of the puzzle, says David Berger of Uppsala Universitys Department of Ecology and Genetics.

Just as with fish, birds and mammals, in the insect world several males often mate with the same female. This leads to a form of sexual selection in which the males sperm compete to fertilise the females eggs. Males that produce more numerous or more competitive sperm often win the competition and become fathers.

Research conducted at the Department of Ecology and Genetics at Uppsala University has succeeded in demonstrating that increased competition between males can lead to a higher rate of harmful mutations in offspring.

Genomic DNA is damaged with every cell division but this damage is usually prevented or repaired by an effective, but costly, cellular surveillance system. The new study shows that sperm production in competing males of the species Callosobruchus maculatus, or cowpea weevil, comes at the expense of this cellular surveillance.

In experiments, male beetles were exposed to radiation in order to damage their genome. After a period of recuperation, the males were allowed to mate with females and become fathers. The researchers then followed their offspring to measure the varying quality of subsequent generations and discovered that males kept in groups, with the concomitant risk of sperm competition, had offspring with a greater number of harmful new mutations than those that lived alone.

The researchers behind the study do however point out that competition between males need not lead to deteriorating gene health in the long term. This is because, as the study also shows, males from populations with high sperm competition over many generations adapt to the new conditions by producing more sperm and more viable offspring compared to males adapted to a life of monogamy.

Even if the direct effect of sperm competition is to increase the number of mutations in offspring, the paradoxical long-term effect of sexual selection may be a lower rate of mutation, explains David Berger.

The researchers behind the study explain that both of these mechanisms play important roles in how genetic variation arises and is maintained in species where males compete to mate. This in turn can affect the potential for evolutionary adaptation, which depends on genetic variation.

The study is published in the scientific journal Nature Ecology & Evolution. J. Baur, D. Berger, (2020), Experimental evidence for effects of sexual selection on condition-dependent mutation rates. Nature Ecology & Evolution. DOI: 10.1038/s41559-020-1140-7

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Male rivals risk having offspring with a greater number of harmful mutations - Mirage News

Recommendation and review posted by Bethany Smith

GeneDx, a global leader in genomics andpatient testing, is celebrating its remarkable 20th anniversary throughout themonth of March.

The Gaithersburg, Maryland company has played an important role in the history of genetic sequencing and the rise of the BioHealth Capital Region as a global biohealth cluster. GeneDx was the very first company to commercially offer NGS (Next Generation Sequencing) testing in a CLIA (Clinical Laboratory Improvement Amendments) lab and has been at the leading edge of genetic sequencing and testing for two decades. The companys whole exome sequencing program and comprehensive testing capabilities are world-renowned.

In its storied 20 yearhistory, GeneDx has provided genetic testing to patients in over 55 countries.The company is known globally as world-class experts in rare and ultra-rarediseases.

In 2000, GeneDx was founded by former National Institutes of Health (NIH) scientists Dr. Sherri Bale and Dr. John Compton. These two genomics experts and thought leaders started GeneDx to complete an important mission: To provide rare and ultra-rare disease patients and families with diagnostic services that were not commercially available at that time.

Prior to launching GeneDx, Bale spent 16 years at NIH, the last nine as Head of the Genetic Studies Section in the Laboratory of Skin Biology. She has been a pioneer during her storied career, publishing over 140 papers, chapters and books in the field. Her 35-year career includes deep experience in clinical, cytogenetic, and molecular genetics research.

Before partnering with Bale to form GeneDx, Compton was an investigator at the Jackson Laboratory, and for the last nine years as a senior scientist in the Genetics Studies Section at the NIH. Comptons work on the molecular genetics of inherited skin disease and expertise in laboratory methodology is known throughout the world. Compton has remarkable experience in the development and application of molecular biological techniques to answer questions about genetics and epidermal differentiation.

GeneDx, like manysuccessful BHCR life science companies, had a humble start, operating initiallyout of the Technology Development Center incubator. Just six years later,GeneDx was acquired by BioreferenceLabs for approximately $17M.

From there, the companylaunched its first array CGH (Comparative Genomic Hybridization) or aCGH testin 2007. An array CGH is also called microarray analysis, which is a atechnique enabling high-resolution, genome-wide screening of segmental genomiccopy number variations (NIH). By 2008, GeneDx had launched its Cardiology NextGeneration Sequencing Panel and by 2011 the company had commercialized itsneurology testing program. In 2012, GeneDx launched its Whole Exome Sequencing (XomeDx) for which it has become so well known in the genomicfield. A year later its Inherited Cancer Panels hit the market. 2018 saw thecompany achieve a significant milestone when it announced ithad performed clinical Exome Sequencing on more than 100,000 individuals.

Both Bale and Comptonhave since retired and GeneDx is currently led by Chief Medical Officer Dr. Gabriele Richard;Chief Innovation Officer Kyle Retterer, MS;Rhonda Brandon, MS

Chief InformationOfficer; and Dr. Sean Hofherr, FACMG, CLIA Laboratory Director & ChiefScientific Officer.

GeneDx has come a longway from its incubator headquarters over the past two decades. With over 450employees, the company continues to deliver on its mission to provide crucialdiagnostic genetic testing capabilities to patients and families across theglobe.

Happy Anniversary GeneDX. Heres to many more.

Steve has over 20 years experience in copywriting, developing brand messaging and creating marketing strategies across a wide range of industries, including the biopharmaceutical, senior living, commercial real estate, IT and renewable energy sectors, among others. He is currently the Principal/Owner of StoryCore, a Frederick, Maryland-based content creation and execution consultancy focused on telling the unique stories of Maryland organizations.

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GeneDx Celebrates 20 Year History as Pioneer In Genetic Sequencing and Testing - BioBuzz

Recommendation and review posted by Bethany Smith

Could public health in India be better served by genome testing tailored specifically to the Indian population? The answer could be yes.

Diagnostic techniques have been built and developed for the developed markets so obviously, the cost structure is accordingly, argued Nikhil Jakatdar, chief executive officer (CEO) of GenePath Diagnostics in an interview with the Economic Times. The relevance of this test has been designed for the Caucasian population and so to bring it to India the challenge involves around how you make it relevant to the Indian genome.

This raises an important question. Given the genetic diversity of India, how can genetic testing kits tailored for the use on European genomes be fully optimised for testing within India? Keeping this in mind, to what extent would genetic testing kits built specifically with India in mind benefit Indias medical system?

The first study resulting from the GenomeAsia 100K project has revealed that Asia has at least ten distinct genetic ancestral lines, compared to the single genetic lineage found in northern Europe. Indias population is diverse, with many different ancestral lines in different regions. As such, genetics vary significantly across the country, meaning a single Indian genetic test would be an improvement on current testing methods, but would likely need a more tailored approach.

India represents almost twenty percent of the worlds population and is anticipated by some to become the worlds most populous nation in the coming decade. Despite this only 0.2 percent of fully mapped genomes in global databanks are of Indian origin.

However, despite Indias minuscule representation within global gene databases, numerous genes have been discovered among the Indian population that predispose individuals to certain diseases. A previous example of this was the finding that the Indian population has a high prevalence of a number of genes that are implicated as risk factors for diabetes. Some of these genes were found to be unique to the Indian subcontinent, indicating a unique risk factor to the Indian population. Knowledge of such genetic traits can allow for the healthcare system to adapt and focus on prevention in a way that is more effective among at-risk populations.

Tailoring genome testing to Indias population can allow for the tests to make note of these unique risk factors, granting far better accuracy when assessing an individuals chances of developing a condition in the future.

As Jakatdar notes in the interview, a lot of tests have been built from ground up through pure R&D [research and development] by us here [in India] so that is the huge milestone when you can actually create tests for Indian market built in India by companies in India. Many of these tests were designed for the US market, however, given the capacity for both research and production of new genetic testing products are already in the domestic market. The development of tests specifically for India is not a far-flung eventuality, but a very real possibility in the coming years.

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India-specific genome tests: The future of healthcare - Hyderus Cyf

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At age 42, Amy Klein had already suffered three miscarriages and gone through several rounds of IVF. She wasnt done trying to have a baby. But she worried that her age likely meant that her eggs had chromosomal abnormalities that kept her from getting pregnant.

So starting in 2012, the health reporter opted for a controversial addition to the fertility toolkit: She went through four rounds of additional egg retrieval, and had those embryos frozen and genetically analyzed for abnormalities.

The basic in vitro fertilization (IVF) process kick-starts embryo formation by fertilizing an egg, or many, with sperm in a petri dish. Kleins plan was to add an optional and costly method called preimplantation genetic testing (PGT), to look for the most viable embryos in the bunch. Once the embryo reaches a stage called a blastocyst, technicians take a handful of cellssix or seven, aboutto test them for genetic abnormalities that could result in disease or miscarriage.

Read more:
The potential pitfalls of an IVF add-on - Quartz

Recommendation and review posted by Bethany Smith

What Afrofuturism does is trouble the notion that time only moves in one direction. Eve Ewing, sociologist, poet, and visual artist from Chicago

1. a movement that imagines alternate realities and futures from a Black cultural and political perspective

Afrofuturism responds to the substantial absence of people of color in speculative art and fiction. As Ytasha L. Womack writes in her 2013 book chronicling the evolution of Afrofuturism in science fiction and fantasy, Even in the imaginary future people cant fathom a person of non-Euro descent. Given the role these genres now play in our collective political and social imagination, Afrofuturism offers a glimpse of a future with Black people not only present, but inhabiting worlds where science and technology speak directly to the Black experience. The term itself wasnt coined until the 1990s, but decades earlier, Black artists had already begun fusing the traditions and cultures of the African diaspora with stories and imagery centered on technological innovation and space exploration. Pioneering science fiction writer Octavia Butler began penning novels inthe 1970s featuring African American protagonists grappling with social hierarchies, trauma and the legacy of slavery. Now, Ava DuVernay is reportedly adapting for television Butlers novel Dawn, about a Black woman resurrecting the human race after nuclear fallout.

Yes, the comic book series and hit 2018 film is perhaps the most popular example of Afrofuturism. Utopian Wakanda is based on an alternative history of an imaginary African nation. Having escaped colonization, Wakanda develops intothe most technologically advanced society in the world and must consider its responsibilities to those outside its borders. But Afrofuturism is having a huge pop culture moment right now, too, from Janelle Mones Metropolis albums (featuring the singers android alter ego) to Beyoncs Lemonade.

As a philosophy of history and science, Afrofuturism can actually help unearth and re-envision the past. The work of sociologist Alondra Nelson, who researches the intersection of race with health and science, is often described as Afrofuturist. Her 2016 book, The Social Life of DNA: Race, Reparations and Reconciliation After the Genome, explores how genetic testing revealed new origins and histories of enslaved Africans and their descendants. Some Afrofuturists have emphasized that race is itself a technologya false narrative deployed for centuries as a tool of oppression and control. Afrofuturism opens the space to imagine what Black futures might look like outside this history of colonization and white supremacy.

This is part of The Big Idea, a monthly series offering brief introductions toprogressive theories, policies, tools and strategies that can help us envision a world beyond capitalism. For recentIn These Timescoverage of liberatory Black art and the power of speculative fiction, see, Black Panther Engages with Decades of Black Liberatory TheoryAnd Is Also a Great Movie, The Climate Crisis Is Mind-Boggling. Thats Why We Need Science Fiction, and Sorry To Bother You Is the Anti-Capitalist Black Comedy Weve Been Waiting For.

As our editorial team finalizes plans for our coverage of the 2020 Democratic primary, we want to hear from you:

What do you want to see from our campaign coverage, and which candidates are you most interested in?

It only takes a minute to answer this short, three-question survey, but your input will help shape our coverage in the months to come. Thats why we want to make sure you have a chance to share your thoughts.

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The Big Idea: Afrofuturism - In These Times

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People walk towards a Covid-19 Assessment Centre at Michael Garron Hospital, in Toronto, on March 15, 2020.

Christopher Katsarov/The Globe and Mail

The words on the sixth page of Ontarios pandemic plan for cancer patients are dry and bureaucratic, but there is no mistaking their weight.

In the event of a widespread pandemic, the document warns, it is realized that even all Priority A patients might not receive prompt treatment.

Priority A is how Cancer Care Ontario, now part of the superagency Ontario Health, describes in a pandemic plan patients whose pain is unbearable or whose situation is immediately life-threatening. The plan was sent to vice-presidents of regional cancer services across the province last week.

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Updated on March 10 as the Canadian health-care system prepared for outbreaks of the new coronavirus, Cancer Care Ontarios plan provides a glimpse of what could happen to some of the countrys most vulnerable patients as COVID-19 spreads further.

At the Princess Margaret Cancer Centre, Canadas largest, oncologists are already combing through their files, searching for appointments that can be postponed.

All of our clinicians are looking at their patient volumes and looking at who might be able to have appointments pushed out if theyre for long-term follow-up [and] who might we be able to move to a virtual assessment," said Marnie Escaf, senior vice-president and executive lead at Princess Margaret, part of Torontos University Health Network.

However, the cancer centre has not yet had to take the more serious steps outlined in the pandemic plan, a copy of which was obtained by The Globe and Mail.

First to go would be long-term follow-up appointments for cancer survivors, routine screening for breast, colon and cervical cancer, genetic testing related to cancer, and clinics for patients with non-melanoma skin cancer, according to the document.

Cancer patients would be divided into priorities A, B and C, with patients in the C category the least likely to need and to receive treatment or surgery right away.

A surgical patient with an obstruction or bleeding that requires immediate surgery would count as priority A, as would patients who had been receiving chemotherapy or radiation to shrink a tumour before surgery.

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Most patients with solid tumours would count as priority B, provided delays were in the range of 4 weeks."

Patients with some thyroid cancers, early prostate cancer and non-melanoma skin cancers would be relegated to priority C.

Patients who disagreed with their category would have the option of appealing to a local appeals committee made up of the Medical Director, the relevant Program Director, a bioethicist if available and others felt relevant to the particular decision.

Still, cancer surgeries are less likely to be delayed than other types of operations.

In a memo about the cancellation of elective surgeries sent Tuesday to doctors in the Calgary area, Alberta Health Services wrote that, It is expected that the pandemic will continue for several months, and as such, stopping oncological surgery at this time does not seem appropriate.

Sandra Krueckl, vice-president of cancer control for the Canadian Cancer Society, said news of cancellations and postponements has only started reaching cancer patients.

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Its always concerning when we have a scenario that forces [cancer agencies] to reduce or change access that people have to care. These are really challenging times, Dr. Krueckl said. "It does become necessary to think proactively about how we can best serve everybody.

Keeping the coronavirus out of cancer centres is another top priority, according to Bob Bell, a former Ontario deputy health minister who was chief operating officer at Princess Margaret in 2003 when SARS forced physicians to evaluate patients with respiratory symptoms in a makeshift assessment area behind the hospital.

We had oncologists literally have discussions about patients on the sidewalk wearing ski jackets, stethoscopes hanging from their necks, he said. They made the right diagnoses. We did not get SARS at Princess Margaret Hospital."

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Ontario hospitals warn COVID-19 trumps cancer care in event of outbreak - The Globe and Mail

Recommendation and review posted by Bethany Smith

ELMWOOD PARK, N.J., March 17, 2020 /PRNewswire/ --BioReference Laboratories, Inc., an OPKO Health company (NASDAQ: OPK), today announced a collaboration with the New York City Health and Hospital Corporation (NYC Health + Hospitals) to provide coronavirus disease 2019 (COVID-19) testing. NYC Health + Hospitals is the largest public health care system in the nation serving more than a million New Yorkers annually in more than 70 patient care locations across the city's five boroughs.

"This expanded testing for H+H is critical to protecting the New Yorkers most at risk in this epidemic, especially our seniors and people with chronic health problems," said New York City Mayor Bill de Blasio. "We are in a race against time, and we are trying to rapidly make up the ground lost by the federal government in the initial weeks of this crisis. The new partnership between H+H and BioReference means increased testing and faster resultshelping save lives."

"In support of the public health system as they provide healthcare to vulnerable and at-risk populations, BioReference is committed to prioritizing hospital patients suspected of COVID-19 infections and aid front-line physicians and healthcare providers to quickly and efficiently diagnose patients," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "In addition to the drive-through facilities, this collaboration is yet another example of how the private sector can assist with government agencies to help combat this epidemic."

For more information aboutBioReference Laboratoriesand coronavirus testing options, please visitwww.bioreference.com/coronavirus.

Providers should refer to the most current CDC guidelines for further information on appropriate testing of patients, available here https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html.

About BioReference Laboratories, Inc.BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists. For more information, visitwww.bioreference.com.

About OPKO HealthOPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA. In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed. OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial. It's among a new class of GLP-1/glucagon receptor dual agonists. OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad.

Cautionary Statement Regarding Forward-Looking StatementsThis press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's plans to begin testing for COVID-19 and the timing of and availability of the test, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA

SOURCE BioReference Laboratories, Inc

http://www.bioreference.com

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OPKO Health's BioReference Laboratories and NYC Health + Hospitals Enter into Laboratory Collaboration to Provide Testing for Coronavirus Disease 2019...

Recommendation and review posted by Bethany Smith

In the late summer harvest of 2013, olive farmers in the Puglia region of southern Italy noticed that the leaves on several of their trees were turning brown and their shoots withering. The problem spread from one orchard to another, as more olive farmers found their trees were drying out and beginning to die.

Genetic testing confirmed them to be infected with Xyella fastidiosa, a bacteria originally found in America. Soon outbreaks appeared throughout the Mediterranean, even briefly as far north as Germany in 2016.

The bacteria is mainly spread by sap-sucking insects known as spittlebugs and sharpshooters. As the insects feed, the bacteria is able to infect the vessels that transport water and nutrients around the plant, known as the xylem. As the bacteria destroy the xylem, it slowly chokes the plant.

We are dealing with a very severe situation in southern Italy, said Dr Maria Saponari, based at the Institute for Sustainable Plant Protection in Bari, Italy. Europes researchers were caught off-guard by the epidemic, she explained. When the bacterium was discovered here, there wasnt any research centre in Europe working specifically on this pathogen. We were starting from zero.

The disease can infect a wide range of plants, including shrubs like the myrtle-leaf milkwort and rosemary, oak trees, and important crops like lavender. Food crops including cherry trees, plum trees and olive trees are among the species considered to be at high risk.

In particular, the outbreak has amplified problems in Italys strained olive oil sector. In 2018, the country reported a 57% drop in its olive harvest compared to 2017 a 25-year low. Researchers blamed a frosty spring followed by a summer drought, which weakened the olive trees and left them even more susceptible to infection.

The intense summer weather in southern Italy may also have made it easier for the disease to spread among olive trees as insects carrying the bacteria sought out food in the dry conditions. Here in summer, olives are the only green plants that we see, said Dr Saponari. Olive canopies, for them, (are) like a refuge to survive.

While the disease has been found in a number of EU countries, it appears the strains that have been imported in Corsica or in Spain are much less aggressive than the strain spreading in Puglia, added Dr Saponari.

In response, Dr Saponari is leading one of several Europe-wide projects seeking ways to curb this new threat to Europes olive crops, and monitor its spread. Her XF-actors project is examining olive trees genetics to see if some of the plants have natural resistance to Xyella fastidiosa that can then be used to breed crops that are more resilient against the disease.

We are dealing with a very severe situation in southern Italy.

Dr Maria Saponari, Institute for Sustainable Plant Protection, Italy

Border plants

Researchers on the project are also conducting field experiments to look at natural strategies to combat the disease, such as using kaolin clay as an insect repellent. Others are experimenting with border plants that can be grown around olive groves and other important crops to draw the bacteria-carrying insects away from the crops, and sentinel plants such as the myrtle-leaf milkwort which show symptoms of bacterial infection sooner, allowing action to be taken quickly to contain an infection.

It is also hoped it may be possible to contain the disease by chopping down infected plants, using more insecticide, or planting crops that are less susceptible to the bacterial strain.

The project teams priority lies in assisting the early detection and containment of the disease. Field inspections and new imaging technology developed by the XF-actors project can already predict how the bacteria may spread, and how to contain it. For example, a combination of thermal images, fieldwork, and spectroscopy can now detect infection in plants and trees before any symptoms appear.

All this information can then be put together to give the authorities a better idea of in which areas the disease is more likely to spread, and so where to send their inspectors next.

To date, monitoring and predicting outbreaks has proven difficult. Even tracking the disease-carrying insect vectors involves hours of sweeping trees and shrubs with entomological nets, and scientists still have to unravel exactly how the bacteria passes from the insects to the plants.

(Nets are) the best way to catch them, said Professor Alberto Fereres, an entomologist based at Spains Institute of Agricultural Sciences in Madrid. They are not very much attracted to sticky-colour traps. They communicate by sound they dont use colours as visual cues to find their host plants.

Prof. Fereres works on the XF-actors project while also leading another project aimed at tackling pest-spread pathogens in Europe, called POnTE. Prof. Fereres and his team are hoping to understand how insects transmit bacterial diseases like Xyella fastidiosa.

Their research is providing some early clues for strategies to stem the transmission of the disease. One involves introducing other non-harmful bacteria into the insects that make it harder for Xyella fastidiosa to spread.

These can do two things they can try to suppress the replication of the (Xyella) bacteria, (and) they can also compete with the bacteria in the vector for binding sites, explained Prof. Fereres.

(This) binding site is the precise place where the virus or bacteria binds inside the insects mouthparts, said Prof. Fereres.

His team is also experimenting with antimicrobial peptides short bits of protein and chemicals that can interfere with the bacterias ability to remain inside insects bodies.

The project is trying to prove which insects can pick up the bacteria from a plant and which are able to successfully transfer it to other plants as they feed.

The team are conducting laboratory experiments that place infected insects on plants in controlled environments so they can pinpoint what exactly needs to happen for insects to transmit the bacteria to other plants do they need to bite into the xylem specifically or just into other parts of the plant, for example.

The bacteria could also affect each plant species differently.

We dont know the genetic determinants which lead to the infection of some plant species and not other ones that are genetically close, says Dr Anne Sicard of the Institut National de la Recherche Agronomique (INRAE) in Montpellier, France.

Dr Sicard leads the XYL-EID project, a joint effort between INRAE, the University of California Berkeley, US, and Italys National Research Council, which is analysing the bacterias DNA to find out why such differences occur.

Outbreak origins

The project is searching for genes involved in helping the bacteria adapt to new environments, and in particular what happened in the outbreak in Puglia. They have analysed 74 bacteria samples collected from infected olive trees from across the affected area by sequencing each of their genomes.

This work is already offering some promising insights into the origin of the outbreak. All samples are genetically very similar to one another, confirming that the outbreak in Puglia is the result of the introduction and subsequent establishment of a single strain of Xyella fastidiosa. They also had a genetic similarity to a strain of the bacteria found in coffee plants in Costa Rica.

But while this research may ultimately provide new ways of fighting the disease, it is unlikely to eradicate it, added Prof. Fereres.

We will have to learn how to live with Xyella, but we will have to also develop ways to contain the disease as much as possible and to avoid situations as in the south of Italy.

The research in this article was funded by the EU. If you liked this article, please consider sharing it on social media.

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The fight to save Europe's olive trees from disease - Horizon magazine

Recommendation and review posted by Bethany Smith

Here is a 3D image of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), formerly ... [+] known as the 2019 novel coronavirus (2019-nCoV). (Image: Getty)

Dont you just love conspiracy theories? Especially when two groups of people have pretty much the same conspiracy theory about each other?

Some folks including politicians in the U.S. and China have both suggested that the COVID-19 coronavirus (SARS-CoV2) thats causing the pandemic may actually be a bioweapon that was manufactured in a lab. The only difference between their conspiracy theories is whos being accused of doing the manufacturing.

On the one corner are some people in the U.S. who are hinting or in some cases openly claiming that China put together this virus. For example, look at what Senator Tom Cotton (R-Arkansas) tweeted out back on January 30:

Then, Steve Mosher wrote on February 22 an opinion piece for the New York Post entitled, Dont buy Chinas story: The coronavirus may have leaked from a lab. Take a wild guess at what Mosher wrote about in his piece. By the way, Mosher is not a biomedical scientist, but instead is the president of the Population Research Institute and author of book called Bully of Asia: Why Chinas Dream Is the New Threat to World Order. So chances are that he didnt love China in the first place. But who knows, love works in mysterious ways.

So what evidence have Cotton, Mosher, and others provided to support these suggestions or claims? Incriminating pictures? Suspicious emails? Some awkward selfies? Any kind of scientific evidence?

Well, as Cotton picked out, there just happens to be a biosafety level-four (BSL-4) laboratory situated in Wuhan, China, the city where the whole outbreak started. Oh, and the lab had housed some types of coronaviruses among other pathogens. Yep, thats the evidence.

As you probably know, proximity alone should not imply guilt. That would be like claiming that you farted whenever theres a bad smell and you happen to be in the vicinity. Sure you may have intestines but that doesnt mean that every foul stench emanated from your guts.

Plus, its a lot easier to leak a pocket of air though your butt than a virus from a BSL-4 facility. BSL-4 facilities maintain the highest level of security among bio-laboratories since they do work on dangerous potentially life-threatening agents such as the Ebola, Lassa fever, and Marburg viruses. So its not as if the people inside these labs are playing throw and catch with the viruses and stuffing them into their pockets. To be designated as a BSL-4, the lab has to have the appropriate ventilation systems, reinforced walls, security systems, and construction to keep the wrong things inside and the right things outside.

Is it unusual then to have a BSL-4 facility in a city like Wuhan, China? Not really. There are already at least six BSL-4 facilities in the U.S. in Atlanta, GA, Frederick, MD, Galveston, TX, Hamilton, MT, and San Antonio, TX. According to the Federation of American Scientists website, seven others may be planned, under construction, or possibly finished in various cities such as Boston, MA, and Richmond, VA. These labs in the U.S. also study and house a range of dangerous pathogens. So again having a lab that studies bad pathogens does not mean that the lab released anything.

Not to be outdone, some in China have made similar suggestions, except that its the U.S. that built the virus and released it in China. Well, thats original. For example, take a look at these three tweets from Zhao Lijian, Spokesperson and Deputy Director General, Information Department for the Foreign Ministry of China:

Yes, the claim is that the U.S. released a virus in China so that the U.S. can then eventually suffer the consequences of the spreading virus just a couple months later. Makes a whole lotta sense, except that it doesnt. Where exactly is the real evidence that the U.S. military created SARS-CoV2?

The back-and-forth dialogue has continued with President Donald Trump then referring to SARS-CoV2 as the Chinese Virus as can be seen here:

When questioned why he was using this label rather than the real scientific name of the virus, Trump claimed that it was in response to the claim that the U.S. military had created the virus. The video accompanying the following tweet shows the exchange:

Back and forth. Back and forth. Back and forth.

So, it looks like conspiracy theorists on both sides havent really provided any compelling evidence that SARS-CoV2 was produced in a lab, whether in the U.S., in China, or in the Hogwarts School of Witchcraft and Wizardry.

In fact, there is not only a lack of evidence supporting these conspiracy theories, there has been growing strong scientific evidence against both of them. Scientists, you know the ones who are actually trying to find the truth and solve a problem rather than blame people, have been conducting genetic analyses to determine where the virus came from and how it ended up infecting humans. Although viruses arent exactly like people as they dont seem to have feelings or spread rumors, viruses do have genetic material like people, except their genetic material is not quite as complex as those of humans. Nevertheless, like humans, viruses still pass along such materials when they replicate and evolve. Its not as simple as The Jerry Springer Show using genetic testing to find out if a guy is someones father, but scientists can use more advanced genetic analysis to figure out the origins, the family tree of SARS-CoV2.

Indeed, strong clues had already emerged by February 26, 2020, when a Perspectives piece was published in the New England Journal of Medicine. In the piece, David M. Morens, M.D. and Peter Daszak, Ph.D. from the National Institute of Health (NIH) and Jeffery K. Taubenberger, M.D., Ph.D. wrote: Of course, scientists tell us that SARS-CoV-2 did not escape from a jar: RNA sequences closely resemble those of viruses that silently circulate in bats, and epidemiologic information implicates a bat-origin virus infecting unidentified animal species sold in Chinas live-animal markets.

This wasnt exactly a case of same bat channel, same bat time. But the first, more deadlier SARS virus seemed to cause the 2002-2003 outbreak after it had managed to jump from bats to humans via intermediate hosts such as masked palm civets. Yes, some masked beings may have inadvertently partnered with bats to bring the original SARS virus to humans. So it wouldnt be too surprising if something like that happened again for SARS-CoV2.

This illustration shows a close-up of the protein spikes on SARS-CoV2. (Image: Getty)

Even more evidence of a natural rather than human-made origin for SARS-CoV2 has emerged from a study described in a research letter just published in Nature Medicine. In the letter, a research team (Kristian G. Andersen from The Scripps Research Institute, Andrew Rambaut from the University of Edinburgh, W. Ian Lipkin from the Mailman School of Public Health of Columbia University, Edward C. Holmes from The University of Sydney and Robert F. Garry from Tulane University) described how they had analyzed the genetic sequences that code for the protein spikes on the surface of SARS-CoV2. The virus looks sort of like a medieval mace with multiple spikes sticking out from its spherical shape. These spikes arent just for show as the virus uses them to latch on to a cell that it wants to invade and then push its way into the cell. Very medieval stuff.

Apparently, portions of these spike proteins are so effective in targeting specific receptors on human cells that it is hard to imagine humans manufacturing them, not with known existing technology. The researchers then concluded that this feature and thus the new coronavirus could have in all likelihood only evolved over time naturally. You see humans can make useful stuff like ride-sharing apps but are still quite puny compared to nature when it comes to making stuff like viruses.

In fact, the research team found that the SARS-CoV-2 structure in general is quite different from what humans would have likely concocted. If a human had wanted to create a viral weapon, he or she would have started with the structure of a virus thats already known to cause illness in people. Naturally, if you want to make a weapon, you may want to start with something like a grenade launcher rather than a smoothie maker, not that the virus looks like either. Instead, the structure of SARS-CoV2 is quite similar to those of viruses known to infect bats and pangolins.

So all of this further supports the theory that the virus jumped from bats to humans via some intermediate animal host. This doesnt necessarily mean that the virus started causing trouble as soon as it started infecting humans. An alternative possibility is that it jumped a longer time ago and hung out among humans for a while before eventually evolving into its current troublesome selves. This latter possibility would be somewhat analogous to inviting someone to live with you because he or she initially seemed relatively harmless but then over time finding out that this flat mate has become a terror.

The findings from the genetic analyses are consistent with how SARS-CoV2 is currently behaving. The virus is not acting like a bio-weapon right now. The best bio-weapons kill at a much higher rate and can be readily transported and released. Imagine being told that a bio-weapon might take the lives of 1% to 3.4% of the people that it infects but you dont quite know specifically which ones. The difference between SARS-CoV2 and pathogens like the Ebola Virus or anthrax is like the difference between a bunch of sofas and a collection of missiles. Sure, the former can cause harm but not in a predictable and consistent manner. If someone actually decided to develop SARS-CoV2 as a bio-weapon, that person needs to find a new job.

So there you have it: scientific evidence trumping conspiracy theories. Will all of these scientific findings finally quash the virus-was-made-in-a-lab-and-it-is-your-fault rhetoric between the politicians and on social media? Probably not. Since when has science stopped such political rhetoric. Maybe, though, it will get more people to focus on the much more important matter at hand: trying to control this pandemic together.

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Is COVID-19 Coronavirus A Bioweapon From A Lab? Here Is What Debunks This Theory - Forbes

Recommendation and review posted by Bethany Smith

Posted: Mar 17, 2020 / 04:16 AM CDT / Updated: Mar 13, 2020 / 04:18 PM CDT

Colorectal Cancer Information & Fact Sheet | Colon Cancer Prevention

Colorectal cancer, or cancer of the colon or rectum, is the second leading cause of death from cancer in the United States. Protect yourself from colorectal cancer by learning more about the disease, its symptoms, risk factors and the screenings that could save your life.

Symptoms

Rectal bleeding with bright red blood

Blood in stool, dark stool

Constipation, diarrhea or narrowing of the stool that lasts more than a few days

Sudden weight loss

Fatigue

Abdominal pain

Frequently feeling you need to have a bowel movement with no relief after having one

Risk Factors

Being over the age of 45

A family history of colorectal cancer

Drinking more than 3 alcoholic beverages a day

A previous history of colorectal cancer, high-risk adenomas, ovarian cancer or inflammatory bowel disease

An inherited genetic syndrome

Smoking

Being of African-American descent

Obesity

A sedentary lifestyle

Type 2 diabetes

Prevention and Screenings

Maintain a healthy lifestyle.

You can negate many of the controllable risk factors of colorectal cancer and other diseases by making healthy choices in your everyday life, such as exercising regularly, eating a healthy diet, limiting alcohol and not smoking.

Consider genetic testing.

If you have a family history of colorectal polyps or cancer, you may consider working with a genetic counselor to see if you carry an inherited gene for colorectal cancer. Typically, genetic testing is done for those who have had one or more first-degree family members with colorectal cancer, especially if the family member had the disease at a young age.

Get regular screenings.

Early detection is key to surviving colorectal cancer. When discovered in its early stages, the 5-year relative survival rate for the disease is approximately 90%. Screenings can also help prevent colorectal cancer from forming by helping physicians detect pre-cancerous polyps that need to be removed. People with an average risk of colorectal cancer should begin screenings at age 45. Once you turn 75 years of age, the decision to be screened should be based on your preferences, life expectancy, overall health and the results of prior screenings. Screening options include:

Stool-based tests

Highly sensitive fecal immunochemical test (FIT) conducted once a year

Highly sensitive guaiac-based fecal occult blood test (gFOBT) conducted once a year

Multi-targeted stool DNA test (MT-sDNA) conducted every 3 years

Visual exams

Colonoscopy conducted every 10 years

CT colonography (virtual colonoscopy) conducted every 5 years

Flexible sigmoidoscopy (FSIG) conducted every 5 years, along with air contrast barium enema

Baptist Health is committed to helping you minimize your risk of colorectal cancer, and provide exceptional treatment for the disease should you or one of your family members ever need it. If youd like to discuss your risk for colorectal cancer or schedule a screening, request an appointment with one of our expert physicians.

The rest is here:
What You Need to Know About Colorectal Cancer - KARK

Recommendation and review posted by Bethany Smith

Do I know Im at risk for developing dementia? You bet.

My father died of Alzheimers disease at age 72; my sister was felled by frontotemporal dementia at 58.

And thats not all: Two maternal uncles had Alzheimers and my maternal grandfather may have had vascular dementia (In his generation, it was called senility).

So what happens when I misplace a pair of eyeglasses or cant remember the name of a movie I saw a week ago?

Now comes my turn with dementia, I think. Then I talk myself down from that emotional cliff.

Am I alone in this? Hardly. Many people, like me, whove watched this cruel illness destroy a family member, dread the prospect that they too might become demented.

The lack of a cure or effective treatments only adds to the anxiety.

Just last week, news emerged that another study trying to stop Alzheimers in people at extremely high genetic risk had failed.

How do we cope as we face our fears and peer into our future?

Should I get tested?

Andrea Kline, whose mother, as well as her mothers sister and uncle, had Alzheimers disease, just turned 71 and lives in Boynton Beach, Florida in the United States.

Shes a retired registered nurse who teaches yoga to seniors at community centres and assisted-living facilities.

I worry about dementia incessantly. Every little thing that goes wrong, Im convinced its the beginning, she told me.

Because Kline has had multiple family members with Alzheimers, shes more likely to have a genetic vulnerability than someone with a single occurrence in their family.

But that doesnt mean this condition lies in her future. A risk is just that: Its not a guarantee.

The age of onset is also important. People with close relatives struck by dementia early before age 65 are more likely to be susceptible genetically.

Kline was the primary caregiver for her mother, Charlotte Kline, who received an Alzheimers diagnosis in 1999 and passed away in 2007 at age 80.

I try to eat very healthy. I exercise. I have an advance directive and Ive discussed what I want (in the way of care) with my son, she said.

Lately, Ive been thinking I should probably get a test for APOE4 (a gene variant that can raise the risk of developing Alzheimers), although Im not really sure if it would help, she added.

Maybe it would add some intensity to my planning for the future.

I spoke to a half-dozen experts for this article. None was in favour of genetic testing, except in unusual circumstances.

Having the APOE4 allele (gene variant) does not mean youll get Alzheimers disease. Plenty of people with Alzheimers dont have the allele, said Dr Mark Mapstone, a professor of neurology at the University of California, Irvine.

And conversely, plenty of people with the allele never develop Alzheimers.

Dr Tamar Gefen, an assistant professor of psychiatry and behavioural sciences at Northwestern Universitys Feinberg School of Medicine, strongly suggests having an in-depth discussion with a genetic counsellor if youre considering a test.

Before you say I have to know, really understand what youre dealing with, how your life might be affected and what these tests can and cannot tell you, she advised.

Karen Larsen, 55, is a social worker in the Boston area.

Her father, George Larsen, was diagnosed with vascular dementia and Alzheimers at age 84, and died within a year in 2014.

Larsen is firm: She doesnt want to investigate her risk of having memory or thinking problems.

Ive already planned for the future. I have a healthcare proxy and a living will and long-term care insurance.

Ive assigned powers of attorney and Ive saved my money, she said.

Eating a healthy diet, getting exercise, remaining socially engaged I already do all that, and I plan to as long as I can.

What would I do if I learned some negative from a test sit around and worry? she asked.

Types of tests

Currently, the gold standard in cognitive testing consists of a comprehensive neuropsychological examination.

Among the domains examined over three to four hours are memory, attention, language, intellectual functioning, problem-solving, visual-spatial orientation and perception.

Brain scans are another diagnostic tool.

CT (computed tomography) and MRI (magnetic resonance imaging) scans can show whether parts of the brain have structural abnormalities or arent functioning optimally. PET (positron emission tomography) scans can demonstrate the buildup of amyloid proteins a marker of Alzheimers.

Also, spinal taps can show whether amyloid and tau proteins are present in cerebrospinal fluid.

A note of caution: While amyloid and tau proteins in the brain are a signature characteristic of Alzheimers, not all people with these proteins develop cognitive impairment.

Several experts recommend that people concerned about their Alzheimers risk get a baseline set of neuropsychological tests, followed by repeat tests if and when they start experiencing worrisome symptoms.

When it comes to thinking and memory, everyone is different, said Dr Frederick Schmitt, a neurology professor at the University of Kentucky.

Having baseline results is very helpful and allows us to more carefully measure whether, in fact, significant changes have occurred over time, he said.

Nora Super, senior director of the Milken Institute Center for the Future of Aging, watched her father, Bill Super, and all three of his siblings succumb to Alzheimers disease over the course of several years falling, she said, like a row of dominoes.

One of her sisters was tested for the APOE4 genetic variant; results were negative.

This is no guarantee of a dementia-free future, however, since hundreds of genes are implicated in Alzheimers, Lewy body dementia, frontotemporal dementia and vascular dementia.

Rather than get genetic or neuropsychological tests, Super has focused on learning as much as she can about how to protect her brain.

At the top of the list: managing her depression, as well as stress. Both have been linked to dementia.

Also, Super exercises routinely and eats a MIND-style diet, rich in vegetables, berries, whole grains, nuts, fish and beans.

She is learning French (a form of cognitive stimulation), meditates regularly, and is socially and intellectually active.

According to a growing body of research, physical inactivity, hearing loss, depression, obesity, hypertension, smoking, social isolation, diabetes and low education levels raise the risk of dementia.

All of these factors are modifiable.

What if Super started having memory problems?

I fear I would get really depressed, she admitted.

Alzheimers is such a horrible disease: To see what people you love go through, especially in the early stages, when theyre aware of whats happening, but cant do anything about it, is excruciating.

Im not sure I want to go through that.

Assist Prof Gefen said she tells patients that if (cognitive testing) is something thats going to stress you out, then dont do it.

Making preparations

Nigel Smith, 49, had a change of heart after caring for his mother, Nancy Smith, 81, whos in hospice care in the Boston area with Alzheimers.

When he brought his mother in for a neuropsychological exam in early 2017 and she received a diagnosis of moderate Alzheimers, she was furious.

At that point, Nancy was still living in the familys large home in Brookline, Massachusetts, which she refused to leave.

Eventually, after his mother ended up in the hospital, Nigel was given legal authority over her affairs and he moved her to a memory care unit.

Now, shes deteriorated to the point where she has about 5% of her previous verbal skills, he said. She smiles, but she doesnt recognise me.

Does he want to know if something like this might lie in his future?

A couple of years ago, Nigel said he was too afraid of Alzheimers to contemplate this question.

Now hes determined to know as much as possible, not so much because Im curious, but so I can help prepare myself and my family.

I see the burden of what Im doing for my mother and I want to do everything I can to ease that burden for them.

Kim Hall, 54, of Plymouth, Minnesota, feels a similar need for a plan.

Her mother, Kathleen Peterson, 89, a registered nurse for over 50 years, was diagnosed with vascular dementia five years ago.

Today, she resides in assisted living and doesnt recognise most of her large family, including dozens of nieces and nephews who grew up with Hall.

Hall knows her mother had medical issues that may have harmed her brain: a traumatic brain injury as a young adult, uncontrolled high blood pressure for many years, several operations with general anaesthesia and an addiction to prescription painkillers.

I dont share these and that may work in my favour, she said.

Still, Hall is concerned.

I guess I want to know if Im at risk for dementia and if there is anything I can do to slow it down, she said.

I dont want what happened to my mother to happen to me.

Probably, she speculated, shell arrange to take a neuropsychological exam at some point.

Several years ago, when I was grieving my sisters death from frontotemporal dementia, my doctor suggested that a baseline exam of this sort might be a good idea.

I knew then that I wouldnt take him up on the offer.

If and when my time with dementia comes, Ill have to deal with it.

Until then, Id rather not know. By Judith Graham/Kaiser Health News/Tribune News service

Kaiser Health News is a US national health policy news service. It is an editorially-independent programme of the Henry J. Kaiser Family Foundation.

Read more from the original source:
Dealing with the fear of developing dementia - The Star Online

Recommendation and review posted by Bethany Smith

Financing to speed commercialization of the only FDA-approved oral treatment of its kind for testosterone deficiency1,2

NORTHBROOK, Ill., March 16, 2020 (GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc., a commercial mens health specialty pharmaceutical company, announced today that it has completed a senior debt financing of up to $75M. Morgan Stanley & Co. LLC acted as sole placement agent for the transaction.

Clarus will use the proceeds from this financing to accelerate the commercialization strategy and launch for JATENZO (testosterone undecanoate) capsules, CIII, the first and only FDA-approved oral softgel testosterone replacement therapy for the treatment of men with hypogonadism due to certain medical conditions. This additional investment builds on an exceptional year for the company, which includes hiring multiple key executives and making JATENZO available for patients.

We are thrilled to have this investment as we bring JATENZO to market, said Dr. Robert Dudley, Chief Executive Officer of Clarus Therapeutics, Inc. We can now fully implement JATENZOs commercialization strategy and move Clarus closer to profitability.

About HypogonadismHypogonadism, also known as testosterone deficiency, is a condition in men in which the body does not produce enough testosterone.3 Only those men who are symptomatic and have consistently low results on a reliable testosterone assay should be offered testosterone replacement therapy, according to current treatment guidelines from both the Endocrine Society and the American Urological Association.3,4 Treatment is meant to induce and maintain secondary sex characteristics and improve clinical symptoms associated with testosterone deficiency.4About Clarus Therapeutics, Inc.Clarus is a men's specialty pharmaceutical company developing and commercializing JATENZO, a product protected by patents issued in the United States and in other major pharmaceutical markets around the world. Clarus owns the worldwide, royalty-free commercialization rights for JATENZO.For more information, please visit:www.clarustherapeutics.com.

About JATENZO JATENZO is the first and only FDA-approved oral testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).1,2

JATENZOs proprietary formulation is built around testosterone undecanoatea testosterone prodrug that the body converts to testosterone. In the JATENZO pivotal inTUne (investigational testosterone undecanoate) clinical trial, 87 percent of hypogonadal men treated with JATENZO achieved a mean total testosterone concentration in the eugonadal range at the end of treatment.1 The efficacy and safety of JATENZO was evaluated in 166 adult, hypogonadal males in a 4-month, open-label study. The primary endpoint was the percentage of patients with mean plasma total testosterone concentration (Cavg) over 24 hours within the normal eugonadal range on the final pharmacokinetic visit of the study.

INDICATIONJATENZO (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitation of use

Safety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONS

JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, in men with a known hypersensitivity to JATENZO or its ingredients, or in men with hypogonadal conditions that are not associated with structural or genetic etiologies as JATENZO has not been established for these conditions and there is a risk of increased blood pressure with JATENZO that can increase the risk of MACE.

WARNINGS AND PRECAUTIONS

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

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The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.

There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Please click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure.

Media ContactAmir KhanPhone: (212) 462-8767Email: Amir.Khan@Syneoshealth.com

1JATENZO (testosterone undecanoate) [prescribing information]. Clarus Therapeutics, Inc.

2US Food & Drug Administration. FDA Approved Drug Products. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206089. Accessed October 1, 2019.

3Bhasin S, et al. J Clin Endocrinol Metab. 2018;103(5):1715-1744.

4Mulhall JP, et al. J Urol. 2018;200(2):423-432.

2020 Clarus Therapeutics, Inc. All rights reserved.

JATENZO is a registered trademark of Clarus Therapeutics, Inc.

COR-US-0038 03/2020

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CLARUS THERAPEUTICS ANNOUNCES FINANCING TO SUPPORT THE COMMERCIAL LAUNCH AND AVAILABILITY OF JATENZO (TESTOSTERONE UNDECANOATE) CAPSULES, CIII FOR THE...

Recommendation and review posted by Bethany Smith

Greater alcohol consumption is associated with lower serum bone formation markers in patients living with HIV (PLWHIV) with substance use disorder, according to study results published in Alcoholism: Clinical and Experimental Research.

Previous studies have established that low bone mass is common and fracture risk is increased for PLWHIV. Several factors may contribute to the low bone density, including the effect of HIV itself, low body mass index, hypogonadism, liver disease, and smoking and alcohol consumption.

As limited data are available on alcohol consumption and bone turnover markers, the goal of the current study was to investigate the association between alcohol consumption and bone turnover markers, specifically serum C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N-terminal propeptide (P1NP), in PLWHIV with substance use disorder.

The study cohort included 233 patients, and after exclusion of 35 due to fracture in the preceding year or missing data, the final sample was 198 individuals (median age, 50 years; 38% women). Almost all patients (93%) were prescribed antiretroviral medication, and most (72%) had HIV viral load suppression.

Approximately half (48%) of the study cohort met criteria for both current alcohol and drug dependence. At baseline and 12-month follow-up, the mean daily number of drinks was 1.93 and 1.51, respectively; mean number of heavy drinking days was 4.65 and 3.25, respectively.

Higher average number of drinks/day was significantly associated with lower P1NP (=-1.09; 95% CI, -1.94 to -0.23 per each additional drink). Bone formation was lower in patients who drank on 20 days in the past month (P1NP, -15.45 ng/mL; 95% CI, -26.23 to -4.67) compared with those who did not. Furthermore, a higher number of heavy drinking days was associated with lower bone formation (=-0.58, 95% CI, -1.05 to -0.12 per additional heavy drinking day).

There was a significant association between a phosphatidylethanol level 8 ng/mL and lower P1NP. In addition, an increase in mean drinks per day over 12 months was associated with a nonsignificant decrease in bone formation (=-1.14; 95% CI, -2.40 to 0.12; P =.08 per each additional drink).

As for the effect of change in alcohol consumption over time, the researchers reported that neither change in the number of heavy drinking days nor change in whether a participant had alcohol use on 20 days in a month was significantly associated with bone formation.

There were no significant associations between alcohol consumption and bone resorption.

The researchers acknowledged several study limitations, including that alcohol use was measured only during the 30 days before each study interview and not throughout the follow-up. Data were also missing on nadir CD4 levels and other markers to assess bone formation, and there was no HIV-uninfected comparator group.

Information about low [bone turnover markers] may provide motivation for [PLWHIV] to reduce alcohol use and mitigate risks related to abnormal bone metabolism, concluded the researchers.

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Reference

Kim TW, Ventura AS, Winter MR, et al. Alcohol and bone turnover markers among people living with HIV and substance use disorder [published online March 2, 2020]. Alcohol Clin Exp Res. doi:10.1111/acer.14303

Originally posted here:
Alcohol Consumption Linked to Lower Bone Formation Markers in Patients With HIV - Endocrinology Advisor

Recommendation and review posted by Bethany Smith