Keeping Track: J&J’s Targeted Oncologic Rybrevant, Apellis’ C3 Inhibitor Empaveli Approved; New Filings From Takeda, Lilly
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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First-in-class CMV treatment showed better efficacy in refractory patients with genetic resistance than those without; US FDA advisory committee will separately consider benefit-risk in each type of patient. On the safety side, taste disturbance is the only adverse event that stands out.
Keeping Track: Takeda’s Exkivity Clears US FDA; BeiGene’s Busy Summer
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Apellis Says Mixed Phase III Results Position Geographic Atrophy Candidate For Filing
Apellis plans to file pegcetacoplan for approval as the first drug to treat the advanced AMD condition geographic atrophy, despite the C3 inhibitor hitting its endpoint in only one of two pivotal trials.