Science News: Biogen and the FDA
This week, Peter Simons covers a BMJ investigation that found the FDA's "accelerated approval" process has left ineffective drugs on the market, some for more than 20 years, without follow-up studies to demonstrate efficacy. He also covers further developments in the FDA and Biogen controversy around Alzheimer's drug aducanumab (Aduhelm). FDA’s “Accelerated Approval” Process Leaves Ineffective Drugs on the Market Do we all have Alzheimer’s? Drug makers might want you to think so Biogen pulled Aduhelm paper after JAMA demanded edits Acting FDA Chief Janet Woodcock Ruled Out as Biden Nominee Sage Therapeutics axes 2 zuranolone trials deemed unnecessary for approval in depression