Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Novo Nordisk’s Semaglutide Achieves ‘Cardiodiabesity’ Label
With Wegovy’s new indication for cardiovascular risk reduction in patients with overweight and obesity, the migration of diabetes drugs from a single disease state to address a host of interrelated conditions reaches a new milestone.
Ultra-Rare Tumors: Public-Private Partnership Eyed To Boost Drug Development
US FDA, Foundation for the NIH, and NCI are considering a new PPP aimed at creating a repeatable process for development of drugs to treat ultra-rare cancers where commercial viability is lacking. Stakeholders say industry incentives, IP issues and reimbursement need attention.
BridgeBio May See Quicker Market Entry For Muscular Dystrophy Drug
BridgeBio and US FDA agreed on a path to accelerated approval for BB-418, a Phase III oral candidate for a subset of limb-girdle MD patients. If successful, it would bring BridgeBio’s third product to market.