2022-12-30| In-DepthSpecial

The FDA and Biogen Taking Heat for Aduhelm’s Approval Process

by Reed Slater
Share To
Over a year after the FDA approved Biogen’s Alzheimer’s drug, Aduhelm, on the accelerated approval pathway, the U.S. House of Representatives published a report outlining the atypical processes leading to the drug’s approval. The report faults the FDA for abnormalities in documentation protocol, not adequately representing differing views within the regulatory agency, shifting to accelerated approval in a substantially short timeframe, and approving the drug for a broad label despite a lack of clinical evidence in a wider population. Biogen is under fire for accepting the broad label, knowing it did not test the drug in a broad population and setting a high price, and planning for substantial marketing costs, despite knowing the potential impact on patients and the Medicare system.

GO Prime with only $1.49 now

Junshi’s PD-1 Antibody Meets Endpoint In Phase 3 Lung Cancer Trial
Moderna Welcomes Phase 3 Win For RSV Vaccine
Moving Beyond COVID With mRNA Technology
Rob Knight and Jing-Yuan Fu Elaborate On Microbiome Research Trends at the 7th Asia Microbiome Conference(AMC)
CARsgen Taps Huadong to Commercialize Multiple Myeloma CAR-T in China
Scientists Study Imaging Probes in First-Ever Amputated Human Limb Model
EMA Plans to Issue Liver Failure Warning for Novartis’ Gene Therapy
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!