The week in pharma: action, reaction and insight – week to April 8, 2022
By Barbara Obstoj-Cardwell. Editor
Among regulatory news last week, the US Food and Drug Administration on Monday advised Alnylam Pharmaceuticals of a three-month delay to its review of the New Drug Application for amyloidosis drug vutrisiran. AstraZeneca released strong results from a Phase IIb trial of its cholesterol lowerer AZD8233. Troubled US biotech bluebird bio last Tuesday announced a significant restructuring program, which would involve a 30% reduction in its workforce. US pharma giant Pfizer announced its first M&A deal this year, agreeing a $525 million bid for RSV vaccine developer ReViral. Also, Biogen reacted angrily to the US Centers for Medicare & Medicaid Services’ (CMS) decision to limit coverage of its Alzheimer’s disease drug Aduhelm.
PDUFA delay of vutrisiran a modest headwind to guidance
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