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US FDA’s Most Controversial Drug Approval Decisions, From A To Z

Executive Summary

Following accelerated approval of Biogen’s Alzheimer’s drug aducanumab in the US, we look back at 10 of the FDA’s most controversial drug approval decisions, from Addyi to Zohydro.

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Stock Watch: A Short History Of Placebo Approvals

Biogen’s recent contentious approval put the cat amongst the pigeons in the debate on surrogate markers as a basis for accelerated approval. The history of such approvals goes back to the last century.

The Ups And Downs Of Aducanumab’s Rollercoaster Development Program

The Biogen Alzheimer’s product saw its ‘likelihood of approval’ score from Biomedtracker change directions multiple times as it moved through clinical trials and US FDA review.

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.

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