Keeping Track: Immuno-Oncology Racks Up More Approvals; Bar Still Too High For Advair Generics
The latest drug development news and highlights from our US FDA Performance Tracker.
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FDA’s most recent accelerated approvals for Merck’s Keytruda call for confirmatory trials in a broader patient population than the approved indications, in the latest example of FDA’s growing comfort with multi-purpose confirmatory trials in the PD-1/PD-L1 inhibitor space.
Genocea shifts to preclinical neoantigen-based cancer vaccines rather than advance a Phase III-ready herpes program on its own and Mateon gives up on its lead drug as placebo outperforms. Also, Juno tops recent public company financings and new VC funds back early-stage firms.
The latest cancer drug development news and highlights from our FDA Performance Tracker.