Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker
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Jazz/PharmaMar’s SCLC drug will stay on the market while two more trials with different designs are conducted after confirmatory trial did not meet overall survival endpoint. Citizen petition requesting agency withdraw lurbinectedin underscores vagaries of accelerated approval.
Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals leads to removal of indications for two PD-1/L-1 inhibitors, AstraZeneca’s Imfinzi and Bristol-Myers Squibb’s Opdivo, both of which had failed confirmatory trials.
Public Company Edition: Among other recent large financings, BridgeBio Pharma launched a $650m note sale, CureVac closed a $517.5m follow-on offering and Revolution Medicines raised $260.9m.