Review extension for Alzheimer’s candidate may be positive for Biogen, but it’s not because Woodcock is acting commissioner. To understand the odds, it may be time to get to better know a new generation of US FDA’s drug review leadership.
Wall Street analysts are pointing to Janet Woodcock’s elevation to acting commissioner of the US Food and Drug Administration as be a good sign for the eventual approval of Biogen, Inc./Eisai Co., Ltd.’s aducanumab for Alzheimer’s disease, but agency experts were quick to poke holes in this reasoning.
If anything, Woodcock’s new position makes it more likely she will steer clear of involvement in the application, they told...
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
