| | Webinar: 2021 Apollo Healthcare Predictions Thursday, February 4, 2021 | 1pm ET / 10am PT With so much disruption from COVID-19, this year’s global insights will provide a unique window into the minds of those professionals perhaps most tested by 2020 and their hopes and perspectives for 2021. Register Now! |
WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST As AstraZeneca nears a European green light for its COVID-19 vaccine, the drugmaker notified officials that its first shipments will come in nearly 70% short—cutting some countries’ first-quarter allotments by more than half—following low yields at a production site. Meanwhile, Merck halted work on two of its vaccine candidates, after phase 1 data failed to impress; it will instead focus on therapeutics. That all raises hopes for Johnson & Johnson’s single-dose shot, which could help alleviate supply chain and logistics woes with today's two-dose regimens. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Eric Sagonowsky As AstraZeneca nears European authorization for its highly anticipated COVID-19 vaccine, the drugmaker has notified officials that initial shipments will come in lighter than originally expected. read more |
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Top Stories Of The Week By Ben Adams While the world struggles with two-shot vaccine production as a handful of pharma companies try to make enough for almost the entire global population, a single-dose option from Johnson & Johnson has become a major hope in the fight against COVID-19. read more By Nick Paul Taylor Merck has stopped development of its two COVID-19 vaccine candidates after getting a look at phase 1 data. The vaccine powerhouse said neither candidate triggered immune responses comparable to those achieved by rival jabs, leading Merck to cut its losses and focus on COVID-19 therapeutics. read more By Eric Sagonowsky Following its midstage coronavirus R&D setback, vaccine giant Sanofi is still looking for ways to help in the world’s effort to beat back the pandemic. It’s teaming up with leading vaccine players Pfizer and BioNTech to produce 100 million doses of the rival vaccine—even as Sanofi works to push its own programs through clinical testing. read more By Angus Liu Eli Lilly’s bamlanivimab was the first antibody drug the FDA authorized to treat COVID-19. Now, the Indianapolis pharma has data showing the therapy prevents symptomatic infections. The catch? The data are limited to long-term care facilities, where vaccination is now underway—and despite their utility, antibodies are having a tough time catching on. read more By Conor Hale The FDA has rolled back its emergency authorizations for N95 respirator decontamination systems, cutting down the number of times the agency said each mask could be safely reused. read more By Arlene Weintraub Australian researchers studied the microbiome in mouse models of asthma and were surprised to discover that the molecules L-tyrosine and p-cresol sulfate protected against lung inflammation. Now they're planning to fast-track L-tyrosine into clinical trials in asthma, and they believe it might also be effective against acute lung disease in COVID-19. read more By Beth Snyder Bulik Once again, GlaxoSmithKline has topped pharma company medicine accessibility rankings in a biennial global report, out Tuesday. Compiled by the Access to Medicine Foundation, the report measures how well the largest 20 global Big Pharma companies are making drugs and vaccines accessible to low- and middle-income countries, which account for 83% of the world’s population. read more By Fraiser Kansteiner After pharmacists discovered they could, the FDA allowed a sixth dose to be pulled from Pfizer's five-dose COVID-19 vaccine vial. Now, Pfizer's counting that sixth dose against orders from the U.S. and beyond—and against a recently stepped-up production goal—while governments scramble to buy special syringes needed to extract it. read more By Conor Hale Shortly after Abbott completed its delivery of 150 million rapid antigen tests to the federal government, researchers at the CDC said the card-based diagnostic may fail to catch about two-thirds of asymptomatic cases. read more Resources Sponsored By: Polpharma Biologics Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards. Sponsored By: Blue Matter Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.” Sponsored by: GenScript A significant number of new treatments have been approved so far, but some manufacturing and regulatory guidelines pose challenges for advanced therapies, leading to poor production yields. Sponsored by: Catalent Cell and gene therapies hold the promise to offer novel therapeutic avenues for individuals facing serious medical conditions, but bringing them through the clinical trial process introduces a level of supply chain risk and complexity. Sponsored by: AllianceRx Walgreens Prime Gene and cell therapy are shifting paradigms for manufacturers, patients, healthcare providers and pharmacies. We invite you to learn more by reading Gene and Cell Therapy: A New Age of Medicine. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. 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: 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: 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 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 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. | 