Keeping Track: US FDA Oncology Approvals For Ferring’s Gene Therapy Adstiladrin And Mirati’s Targeted Therapy Krazati
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
You may also be interested in...
US FDA In No Hurry To Withdraw Amgen’s Lumakras Despite Negative Adcomm Vote On Confirmatory Trial Results
ODAC votes 10-2 that the progression-free survival data in CodeBreaK 200 cannot be reliably interpreted due to various study conduct issues; agency assures the committee that it is not currently proposing withdrawal and that multiple regulatory pathways are available for sotorasib, one of two KRAS G12C inhibitors on the market under accelerated approval.
Private Company Edition: Genesis raised $200m, Rapport brought in $150m and Cellares closed a $255m round. Also, Ferring got $300m up front in a royalty deal, Fore Biotherapeutics raised a $75m series D and Vaxxas won a $3.67m Wellcome grant to advance a next-generation typhoid vaccine.
Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.