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.
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Novel agents that received three-month user fee goal date extensions have a slightly higher approval rate than novel applications overall.
US FDA’s approval after a near-unanimous advisory committee vote against Biogen’s Alzheimer’s drug is central to many critics’ arguments, but the acting commissioner says that panel did not vote on the issue of accelerated approval, and that airing of internal agency disagreements could have influenced committee members.
Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.