The week in pharma: action, reaction and insight – week to June 24 2022

Regulatory news last week included a US Food and Drug Administration (FDA) advisory panel voting against approval of Acadia Pharmaceuticals’ Nuplazid for the treatment of Alzheimer’s associated with psychosis (ADP). Also, the FDA put a surprise clinical hold on a trial of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) drug candidate SRP-5051 (vesleteplirsen). Among important research news, AstraZeneca and partner Ionis Pharmaceuticals announced positive results from a Phase III trial evaluating their rare disease candidate eplontersen. Meantime, Enanata Pharmaceuticals has filed a patent infringement suit against Pfizer relating to the latter’s highly successful COVID-10 antiviral Paxlovid. Troubled Belgian biotech Galapagos last Wednesday announced not one, but two acquisitions – CellPoint and AboundBio – aiming to expand into CAR-T therapeutics.

Focus turns to Rett as panel gives Acadia’s Nuplazid a thumbs down

Acadia’s attempt to expand Nuplazid’s label into Alzheimer’s disease psychosis looks to have failed, following an FDA panel vote last Friday that went 9 to 3 against the idea, commented Amy Brown writing on Evaluate Vantage.