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.
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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FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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In this latest episode of Tuning In to the C-Suite podcast, Briana Contreras, an editor with MHE had the pleasure of meeting Loren McCaghy, director of consulting, health and consumer engagement and product insight at Accenture, to discuss the organization's latest report on U.S. consumers switching healthcare providers and insurance payers.
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