In a controversial decision, FDA announced today that it had approved Biogen’s Alzheimer's drug, aducanumab.
“We ultimately decided to the use the Accelerated Approval pathway — a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit,” said the prepared statement from Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research.
An advisory committee of outside experts had voted against recommending approval. Clinical trial results for the drug have been mixed, and at one point the company shelved the drug before re-analyzing trial results and restarting the process for gaining FDA approval.
Conversations With Perry and Friends: Paul Fronstin, Ph.D.
May 9th 2025Perry Cohen, Pharm.D., a longtime member of the Managed Healthcare Executive editorial advisory board, is host of the Conversations with Perry and Friends podcast. In this episode, his guest is Paul Fronstin, Ph.D., director of health benefits research at the Employee Benefit Research Institute.
Listen
FDA Lifts Safety Restrictions on CAR T Therapies After Reviewing Real-World Data
July 2nd 2025FDA officials have determined that information regarding the risks for six CAR T-cell therapies can be communicated through product labeling, which includes a boxed warning for the risks of cytokine release syndrome and neurological toxicities.
Read More
Conversations With Perry and Friends
April 14th 2025Perry Cohen, Pharm.D., a longtime member of the Managed Healthcare Executive editorial advisory board, is host of the Conversations with Perry and Friends podcast. His guest this episode is John Baackes, the former CEO of L.A. Care Health Plan.
Listen