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Week in Review | Amgen Refuses to Pull Tavneos: FDA Showdown Lands Wednesday
Published 1 month, 3 weeks ago
Description
Amgen told the FDA no — a blinded Duke re-analysis of ADVOCATE met noninferiority at 68.1% versus 67.1% but lost superiority, and the deadline is July 29. We unpack the avacopan withdrawal fight, the ChemoCentryx acquisition that bought it, and the EMA committee already moving against it. Plus Elevar's complete response letter for rivoceranib and camrelizumab in first-line liver cancer over a manufacturing inspection, Summit's ivonescimab survival update ahead of its November decision, Sun Pharma's $11.75 billion Organon approval, Scribe Therapeutics' gene editing IPO, Ipsen's Bylvay failure in biliary atresia, and the FDA peptide panel that voted yes on thin evidence.
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