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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.
Joseph Zabinski Advocates for Patient Trust in AI Adoption in Dermatology Care
April 18th 2024Joseph Zabinski, PhD, MEM, vice president, head of commercial strategy and AI, OM1, chatted with MHE editors on the significance of patient acceptance in AI adoption in healthcare, overall and in the dermatology space, stressing trust and transparency.
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DC Roundtable: Patrick Cooney of The Federal Group Drops the Latest on PBM Legislation in Washington
April 11th 2024In this episode of "DC Roundtable," Peter Wehrwein, managing editor of Managed Healthcare Executive, spoke with Patrick Cooney, president of The Federal Group, a lobbying and strategic planning firm in Washington, D.C., about recent developments in Washington concerning PBMs.
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