WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Novavax’s final phase 3 data put down 100% efficacy against severe COVID-19, in countries where new variants of the disease have caused concern—showing that while mutations may limit overall efficacy, the vaccine could still protect against the worst outcomes. Meanwhile, AstraZeneca continues to hit potholes in rolling out its shot, with supply shortfalls and countries suspending usage amid reports of blood clots, despite the company’s real-world data tracking 17 million recipients and an EMA endorsement this week. But what does the future hold? Fierce Biotech looks toward the year’s most-anticipated data, including from COVID vaccines and therapy combinations, but also treatments for cancer, depression, sickle cell and inflammatory diseases. | |
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Featured Story | By Nick Paul Taylor Novavax has linked its COVID-19 vaccine to 100% efficacy against severe disease in countries where variants of concern are prevalent. The final phase 3 data suggest NVX-CoV2373 may protect against the worst outcomes caused by the coronavirus variants, even though the mutations limit its efficacy. read more |
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Top Stories Of The Week By Fraiser Kansteiner European regulators in November raised concerns about lower-than-expected quantities of intact mRNA in commercial batches of Pfizer and BioNTech's COVID-19 vaccine, the BMJ reports. Those issues have been resolved, the EMA says, though the issue shines a spotlight on the complex quality assurance for the cutting-edge vaccines. read more By Arlene Weintraub Baylor researchers showed that treatment with the probiotic L. reuteri or a metabolite of it restored normal social behavior in mouse models of a developmental brain disease similar to autism. They believe their findings could inspire new treatments for brain disorders that include behavioral components. read more By Phil Taylor The first two entries in our 2021 clinical readouts list cover clinical trials of vaccines and therapeutics in COVID-19. Out list also covers familiar ground, featuring emerging drug candidates for cancer, diabetes, central nervous system disease, rare disorders and immunological conditions. read more By Eric Sagonowsky Pfizer made headlines last month when its CFO said the company would look to raise COVID-19 vaccine prices after the pandemic wanes. The company is doubling down on that stance, and it now believes annual vaccinations are "increasingly likely"—meaning Pfizer's likely to collect serious vaccine revenue for years. read more By Eric Sagonowsky AstraZeneca’s COVID-19 vaccine rollout has hit one pothole after another—supply shortfalls, reports of blood clots and countries suspending usage, one by one. The rough ride isn't over yet, either. Even as the company publicly backed its shot's safety, more countries halted their campaigns. And AZ had to cut its EU delivery promises yet again. read more By Ben Adams Two months after GlaxoSmithKline and Merck KGaA’s oncology asset bintrafusp alfa failed to beat out King Keytruda in certain lung cancers, it has followed up with another disappointment. read more By Ben Adams Bluebird bio’s chief medical officer David Davidson, M.D., is hitting the exit, though remaining as a consultant, as the biotech looks to navigate through its gene therapy issues. read more By Angus Liu A big question hanging over AbbVie CEO Richard Gonzalez is whether he can lead the Illinois pharma safely past the patent cliff facing its revenue cornerstone Humira. By the look of 2020’s results, he’s on the right track—and his compensation shows it, with a 11% increase to $24 million. read more By Beth Snyder Bulik As Merck & Co. CEO Ken Frazier heads toward retirement, another top exec is taking his leave. Michael Nally, chief marketing officer in its human health business, will bid goodbye at the end of the month, handing the reins to commercial officer Frank Clyburn, who'll become global president of the business. read more By Conor Hale After six years, Cardinal Health is dropping its Cordis medical device division, makers of cardiovascular catheters and diagnostic hardware, in a $1 billion deal with private equity firm Hellman & Friedman. read more Resources Sponsored By: OCT Clinical Find out why more than 400 clinical trials annually are initiated in Russia by US and EU pharma in the free annual report by OCT Clinical. Sponsored By: Almac Clinical Technologies This industry report reveals qualitative and quantitative candid insight from clinical development insiders and their views on current clinical trial challenges faced amidst uncertainty. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: AmerisourceBergen Corporation Unlock product potential by making the most of your commercialization investments. Sponsored By: Acorn AI Unlock competitive advantage with AI and advanced analytics. Sponsored By: EVERSANA Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How. Sponsored By: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Thermo Fisher Scientific Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain. Sponsored By: Blue Matter, strategic consultants in the life sciences A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones. Sponsored by: Baxter BioPharma Solutions While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored by: Catalent Hear industry experts discuss the recent advances, challenges and considerations in pediatric drug development. Real-life examples presented by the experts illustrate the impact of age-appropriate dose forms for pediatrics and highlight insights into the caregiver perspectives. 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 proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. 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. | 