Woodcock Requests Independent Review Of Biogen-FDA Aduhelm Interaction … Not Approval Decision
Executive Summary
US FDA Acting Commissioner’s request for an HHS OIG review related to the Alzherimer’s drug approval is fairly narrow and continues to frustrate critics who believe the drug should not be approved. Woodcock expressed confidence in the CDER team in the letter to OIG, framing the investigation request as a move to help ensure public trust in the FDA.
You may also be interested in...
Beyond Aduhelm: OIG Review Will Put FDA’s Entire Accelerated Approval Program Under Microscope
HHS Inspector General’s timeline means Congress won’t have findings to use during upcoming user fee renewal debate; ‘review’ is not an ‘investigation’ which could come with potentially more damning legal consequences for the agency.
US FDA Doesn’t Need Conditional Approval Pathway, Cavazzoni Tells House Committee
CDER director says agency has many tools to expedite development and does not endorse adding a pathway similar to EU’s conditional approval. Neurodegenerative diseases hearing in Energy & Commerce Committee focuses more on ALS than Aduhelm.
Roche Deals With Huge Gantenerumab Curiosity At H1 Update
Roche unveiled a strong Q2 performance driven by new medicines and continued strong growth from its diagnostics division but analysts were most keen for clues on plans for gantenerumab, now in Phase III studies for Alzheimer’s disease.