By Barbara Obstoj-Cardwell. Editor
The long-awaited confirmation from the US Senate of Robert Califf’s nomination to become Food and Drug Administration Commissioner was announced last Tuesday, but on a tight vote. On the research front, Sage Therapeutics and Biogen announced confident results for their depressive disorder candidate zuranolone but questioned were raised on its commercial potential. Regulatory developments included the FDA granting accelerated approval for Agios Pharmaceuticals’ Pyrukynd (mitapivat) for a rare form of anemia. But BioMarin had a setback last Thursday when the FDA said it needed more information to lift the clinical hold on the firm’s gene therapy BMN 307 clinical trial.
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