Featured Story | By Max Bayer In an exclusive interview with Fierce Biotech, FDA Commissioner Robert Califf says the agency needs to do a better job of getting post-market data as it looks to fortify trust in the accelerated approval program. His comments came hours before the Centers for Medicare and Medicaid Services stuck with its coverage decision for Biogen's treatment for Alzheimer's. read more |
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Top Stories By Annalee Armstrong BioNTech’s post-Comirnaty future is emerging, with early phase 1/2 data from a solid tumor CAR-T cell therapy showing evidence of efficacy and a safety profile deemed manageable by the famed German biotech. read more By Max Bayer Veru is quitting while it's ahead, closing up shop early on a phase 3 trial for a COVID-19 treatment in the sickest patients after initial data found that it reduced deaths by more than 50%. read more By Annalee Armstrong C4 Therapeutics has learned a lot from just five melanoma patients reporting out from the first cohort in a phase 1 trial for its lead candidate, a IKZF1/3 degrader called CFT7455. In data to be presented at the AACR meeting in New Orleans on April 12, C4 will showcase the early efficacy signals. read more By Annalee Armstrong About seven out of 10 patients with EGFR-mutated lung cancer progress after taking AstraZeneca’s Tagrisso, and a third of those patients see their cancer spread to the brain. Blueprint wants to change that. read more By Angus Liu Existing CAR-T therapies for blood cancers require painstaking preparation. Exuma Biotech believes its rapidly manufactured cell therapy can save patients precious time and obviate the need for preconditioning. read more By Angus Liu Senti Bio is perhaps best known for logic-gated gene circuits to control the therapeutic activity of cell and gene therapies. But CEO Tim Lu, M.D., Ph.D., has early data showing the biotech's CAR-NK platform has more tricks up its sleeve. read more By Angus Liu Pfizer has signed on a new chief financial officer whose dealmaking experience could prove invaluable for the New York pharma as it looks to deploy its COVID-19 vaccine and drug windfall. read more By Anastassia Gliadkovskaya GameChangeVR automates psychotherapy, guiding users with a virtual coach. Significant benefits were obtained after six sessions, according to the study. read more By Andrea Park The next wave in a yearslong program of rolling layoffs at a Stryker facility in Florida is scheduled to take place at the end of May, the company said in a recent filing with the state. read more By Fraiser Kansteiner The specter of particulates has forced another recall—this time on Moderna’s massively successful COVID-19 vaccine Spikevax—and the latest pull isn’t contract manufacturer Rovi’s first brush with contamination, either. read more Resources Sponsored by: Nethealth Net Health, experts in wound care and dermatology clinical trials, have a new eBook: 5 Rules to Enhance Clinical Trials in 2022, find out how to recruit the right participants, connect patients and researchers with technology, manage costs and more. 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