WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Your roundup of the biggest and most popular stories from each of our publications. | |
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Featured Story | By Ben Adams AstraZeneca’s executive vice president of oncology R&D José Baselga, M.D., Ph.D., 61, has passed away. read more |
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Top Stories Of The Week By Arlene Weintraub GlaxoSmithKline has fired company veteran Moncef Slaoui from the board of its majority owned Galvani Bioelectronics, following allegations from a GSK employee of sexual harassment. GSK CEO Emma Walmsley told employees she is "shocked and angry" and that the company will rename its Slaoui Center for Vaccines Research. read more By Amirah Al Idrus Private biopharma companies raised nearly $20 billion in 2020, blowing past the record $17.9 billion set in 2018. Here are the top 10 fundraising rounds, which include some "truly monstrous" financings like Sana Biotechnology's eye-watering $700 million series and Lyell Immunopharma's $493 million raise. read more By Eric Sagonowsky AstraZeneca’s vaccine prospects were looking up Monday when the company reported solid results from a new phase 3 trial it needed to win U.S. approval. Then, sometime after midnight, U.S. officials took the rare step of publicly questioning whether those data were actually complete. read more By Ben Adams Pfizer and Eli Lilly’s long journey to a potential FDA approval for tanezumab still looked rocky today after review documents from the regulator cast doubt over its safety. read more By Beth Snyder Bulik The #FierceMadness DTC ad tournament is down to the Sweet 16. The winners include Bayer, Roche, Novo Nordisk, J&J, Novartis and Gilead, but just like this weekend's NCAA March Madness surprises—Ohio State knocked out by Oral Roberts and Loyola topping Illinois to play through—the pharma ad matchups saw several smaller campaigns beating big ones. read more By Amirah Al Idrus Frequency Therapeutics is going back to the drawing board. After showing promise in phase 1, four dosing regimens of its hearing loss treatment did no better than placebo in a phase 2a study. The company will press ahead with a single-dose regimen and is waiting on final results from this study as well as readouts from two more phase 1b studies to plot its next steps. read more By Angus Liu Novo Nordisk’s been eyeing a weekly dosing regimen for its GLP-1 diabetes med Ozempic to better compete with Eli Lilly’s rival drug Trulicity. But that quest has hit a serious setback. The FDA refused to review the new formula—an unusual step indicating serious shortfalls in an approval application. To file again, Novo needs to offer up more manufacturing data. read more By Conor Hale The FDA has authorized the use of its first digital, machine-learning-powered device to help screen people for COVID-19. read more By Angus Liu Another multiple sclerosis drug is here. Johnson & Johnson won an FDA green light for Ponvory, also known as ponesimod, for relapsing forms of multiple sclerosis. It's the first oral drug with a head-to-head win against Sanofi's blockbuster Aubagio, but will that be enough to help it steal market share? read more By Arlene Weintraub Tumors need a variety of nutrients to grow, so it stands to reason that starving them of this sustenance could be a viable strategy for treating several types of cancer. Researchers at Sanford Burnham Prebys Medical Discovery Institute described two such strategies this week, one aimed at melanoma and the other at pancreatic cancer. read more Resources Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. 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. 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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. 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