US FDA’s Post-Aduhelm Reforms Include Updated Alzheimer’s Development Guidance, Record-Keeping On Sponsor Meetings
Agency already had an action plan in hand to address concerns with the aducanumab review even before the controversial approval, but it has not been fully implemented yet. A House committee report is another nudge.
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FDA Commissioner Robert Califf said pharma should not be the sole entity handling postmarket research.
Biogen faces complex logistics in shutting down a multinational trial with more than 200 sites and approximately 1,000 patients enrolled; company also is facing calls to publish data collected from the unfinished study as well as other aducanumab trials.
Biogen’s decision to discontinue is Alzheimer’s treatment Aduhelm cements its status as one of the most spectacular commercial failures in biopharma history. But its impact on biopharma policy is still extraordinary.