Beam sheds more light on clinical hold slapped on gene-edited CAR-T Codiak's $2.5M check in July isn’t enough to stave off job cuts and restructuring Sanofi, seeking to stem bleeding at hemophilia A unit, gets FDA priority review for rival to Roche Arch builds bridge to new class of medicines, leading $50M investment in the AI-enabled Vilya Cleaning house: Scientists find genetic quirk may help clear out beta amyloid, treat Alzheimer's A pharmaceutical jack of all trades? Novo CEO touts semaglutide's potential in NASH, Alzheimer's and its hot start in obesity Appeals court strikes down bid to reinstate OSHA COVID-19 protection standard Sandoz, Amneal and Rhodes join Teva in nationwide generic Adderall shortage as demand spikes FDA clears BrainsWay's 2nd neurostimulation approach to depression treatment SaNOtize bags $24M to fund phase 3 trial of COVID-19 nasal spray InterWell Health finalizes $2.4B kidney care merger to combine tech, value-based care capabilities Pfizer, Moderna bivalent COVID booster nods could land this week: report LGBTQ+ community-led Folx launches new project dealing with monkeypox Featured Story | By Max Bayer Beam Therapeutics is disclosing more details about a clinical hold placed on its phase 1-ready CAR-T. The FDA's questions centered on more data from controls and results from off-target editing tests. read more |
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Top Stories By Gabrielle Masson Despite a $2.5 million check from a vaccine alliance earlier this summer, Codiak BioSciences is still struggling. The biotech is laying off around 30 employees and trimming its pipeline. read more By Nick Paul Taylor The hemophilia A market has a new date for the diary: Feb. 28. Officials at the FDA put the date on the agenda at Sanofi and Sobi by accepting the partners’ hemophilia A drug candidate efanesoctocog alfa for priority review. read more By Nick Paul Taylor Arch Venture Partners is bankrolling a biotech that could render high-throughput screening obsolete. The biotech, Vilya, starts life with a $50 million, Arch-led series A round and technology to design a new class of medicines. read more By Gabrielle Masson Scientists have discovered a new druggable pathway that may boost beta amyloid clearance, holding the potential to be used to help prevent Alzheimer’s dementia in humans. read more By Fraiser Kansteiner Novo Nordisk’s recent growth renaissance has flourished thanks in no small part to semaglutide—the GLP-1 molecule behind the company’s leading trio of Ozempic, Rybelsus and Wegovy. But even as the drug's metabolic empire prospers, Novo Nordisk isn’t letting its GLP-1 rest on its laurels. read more By Robert King A federal appellate court ruled it doesn't have the authority to get OSHA to make permanent a COVID-19 emergency protection standard. read more By Fraiser Kansteiner Alongside Teva, Amneal Pharmaceutical, Purdue subsidiary Rhodes Pharmaceuticals and Novartis’ soon-to-be-spun-off generics unit Sandoz have generic extended-released Adderall on back order, according to a recent supply update from the American Society of Health-System Pharmacists, which tracks drug shortages. read more By Andrea Park Nearly a decade after reeling in the first FDA nod allowing its deep brain stimulation technology to help treat major depressive disorder, BrainsWay has doubled back with another agency-cleared depression treatment. read more By Nick Paul Taylor SaNOtize has raised a $24 million series B round, giving it the cash to fund its ongoing phase 3 COVID-19 prevention trial and other research into its nitric oxide nasal spray (NONS). read more By Heather Landi InterWell Health completed a three-way merger with Fresenius Health Partners and Cricket Health to create a kidney care powerhouse on track to have $11 billion in costs under management by 2025. read more By Fraiser Kansteiner The FDA could authorize variant-targeted mRNA vaccines from Pfizer and Moderna as early as Wednesday, Politico first reported, citing three people close to the decision. read more By Sharon Klahr Coey Folx Heath is a virtual care provider designed by and for the LGBTQ+ community, so the rise in monkeypox cases and the effect if was having on the community, spurred the company to act. Folx knew it needed to get in front of the issue, which was mired in confusion, as a source of solid health information and solutions. read more Resources Sponsored by: Ferma.AI, a Product of ZoomRx Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Catalent Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Bio-Techne Advanced research requires advanced tools. Our next-generation ELISA takes a fraction of the time to run eight analytes simultaneously while saving your sample volume. Simply load, scan, and insert your cartridge and come back to fully analyzed results in 75 minutes. Rethink your ELISA, with Ella. Sponsored by: Thermo Fisher Scientific Set a solid foundation for successful scale-up of buffer preparation. The total immersion, transformative training will take place at the Harvard Club in Boston. 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