FDA Approves Biogen’s Alzheimer’s Drug, Aducanumab
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.
Healthcare hasn't been a priority of the second Trump administration so far, panelists at the Asembia agreed. Medicaid may loom large, though, as the administration and congressional Republicans look for ways to slash government spending as a way of offsetting major tax cuts.
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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.
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Breaking Down Health Plans, HSAs, AI With Paul Fronstin of EBRI
November 19th 2024Featured in this latest episode of Tuning In to the C-Suite podcast is Paul Fronstin, director of health benefits research at EBRI, who shed light on the evolving landscape of health benefits with editors of Managed Healthcare Executive.
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Survey: What Patients and Providers Are Thinking About Healthcare Access
April 28th 2025Patients and providers found common ground on the importance of correct billing estimates but did not see eye to eye in terms of digital scheduling tool use, according to a new survey by Experian Health.
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