WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST This week the NIH scrapped a trial of Eli Lilly’s COVID-19 antibody, ending enrollment early after finding the treatment would be unlikely to succeed in hospitalized patients. Still, Lilly hopes its drug will slow the disease in earlier patients, hypothesizing that those hospitalized may see fewer benefits from antibodies after longer infections and severe symptoms. Meanwhile, a separate study of convalescent plasma in India found the therapy had no effects on disease progression or all-cause mortality, raising doubts about the efficacy of a treatment given to more than 100,000 people in the U.S. Those stories, plus the most influential people in the continuing fight against COVID-19, follow below. | |
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Featured Story | By Eric Sagonowsky For the pharma world, the pandemic has been a crisis with a purpose. Scientists, regulators, biotech companies and drugmakers large and small have taken center stage as they hunt for drugs, vaccines, diagnostic tests and other aids in halting the pandemic. We've chosen 22 of the people who hold our COVID-19 future in their hands. read more |
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Top Stories Of The Week By Angus Liu Deaths after flu vaccination keep rising in South Korea. But as health authorities there work to calm concerned citizens by refuting a connection between the two, Singapore has taken the precautionary measure of suspending two of the vaccines given to people who later died. read more By Nick Paul Taylor The NIH has scrapped a clinical trial of Eli Lilly’s anti-SARS-CoV-2 antibody in hospitalized COVID-19 patients. Investigators stopped enrolling patients in the study after finding LY-CoV555 is unlikely to improve outcomes in the studied patient population. read more By Nick Paul Taylor A randomized phase 2 clinical trial has found convalescent plasma has no effect on progression to severe disease or all-cause mortality in COVID-19 patients. The data raise significant doubts about the efficacy of an intervention that has been given to more than 100,000 people in the U.S. read more By Kyle Blankenship As COVID-19 continues to rage worldwide, health authorities worry that a perfect storm of the novel coronavirus, pneumonia and seasonal flu could overtake hospital systems. Two major pneumococcal vaccines are already seeing shortages in the EU, which could be an ill omen for the coming months. read more By Eric Sagonowsky As the leading COVID-19 vaccines move closer to potential emergency use, the research and regulatory processes have been intensely scrutinized. But there’s one area that hasn’t seen as much attention so far—manufacturing facility inspections. read more By Nick Paul Taylor Bayer has struck a deal to acquire Asklepios BioPharmaceutical for $2 billion upfront. The deal, which features an additional $2 billion in milestones, will give Bayer control of an adeno-associated virus (AAV) gene therapy platform and a pipeline led by clinical-phase treatments for Parkinson’s, Pompe disease and congestive heart failure. read more By Arlene Weintraub A research team led by Ohio State University discovered an immune cell that might be harnessed to partially reverse nerve damage in MS, ALS and other brain disorders. It's a type of white blood cell known as a granulocyte, and it works by secreting growth factors that help axons of the central nervous system regenerate. read more By Eric Sagonowsky As new COVID-19 cases spike in the U.S., and ahead of an expected winter surge, the FDA just issued its first full approval for a drug to treat the disease—Gilead Sciences’ Veklury, formerly known as remdesivir. But the approval closely follows a large trial that showed no benefit for the therapy, and experts quickly questioned the FDA's move. read more By Angus Liu AstraZeneca and Daiichi Sankyo are rapidly gaining traction for their Enhertu in HER2-positive breast cancer. Next up? An early chance at expanding the blockbuster-to-be into gastric cancer, armed with a first-in-class survival win and an FDA priority review. read more By Ben Adams Foundation Medicine has nabbed a U.S. green light as the only companion diagnostic for Bayer’s Vitrakvi (larotrectinib). read more Resources Sponsored By: Paysign This white paper outlines how one such law, Minnesota’s Alec Smith Insulin Affordability Act, has impacted the pharmaceutical industry and provides guidance about strategies businesses can employ to rapidly add support. Sponsored By: Veeva Learn how to plan immersive digital event experiences Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. Sponsored By: ICON Clinical Research Ltd The culture of clinical research is evolving from one directed by researchers to one driven by the needs of patients and those who care for them. Sponsored By: The PerkinElmer Signals Screening Team Creating integrated HCS workflows in a single platform increases accuracy; reduces time and helps to identify the most appropriate hits or drug candidates. Learn more about a reliable method for creating a more efficient, faster, 3D image and multi-parametric data analysis workflow. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Cascade Chemistry, API CDMO Struggling with complex chemistry to get APIs for clinical trials? Find out what to look for in an API CDMO partner to gain expertise and speed that lead to success. Sponsored by: EVERSANA An integrated compliance model can be the competitive differentiator to commercialization and move the needle from cost center to value. Learn How. Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Formedix Learn how to save time and reduce costs and complexity by streamlining the clinical trial process. Sponsored by: LabVantage Want to leapfrog lengthy LIMS deployments and position your pharmaceutical lab for success? Find out how with LabVantage Solutions. Sponsored by: Thermo Fisher Scientific Learn how to safeguard supply, improve distribution and reduce program costs and risks Sponsored by: Clinical Ink Learn how the right data capture solution can prompt the patient to follow the correct procedures and automatically sort the responses, according to protocol. Sponsored by: Guidehouse While COVID-19 has shifted the rules of the healthcare industry, research shows there was already progress on changes being made for how pharma companies are launching products. Sponsored by: Blue Matter Consulting Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers. A complete Life Science Industry Snapshot in One Report Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. | 