June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.
One year after the US Food and Drug Administration’s accelerated approval of Biogen, Inc.’s Aduhelm (aducanumab-avwa), the Alzheimer’s treatment remains a hot and divisive topic in drug development circles.
Reflecting back on the controversy, it appears the approval and the following pricing and reimbursement decisions could have long-lasting implications,...
Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
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.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
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 An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
