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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Watching The Review Clock: Are US FDA Goal Date Extensions Reason For Optimism?
Novel agents that received three-month user fee goal date extensions have a slightly higher approval rate than novel applications overall.
Pink Sheet Podcast: Medicare Inflation Rebates And Negotiation, Leqembi Reimbursement, US FDA Gene Therapy Chief
Pink Sheet reporter and editors discuss the first round of mandated Medicare inflation rebates and new guidance on price negotiations, consider the VA’s decision to cover the Alzheimer’s drug Leqembi, and the US FDA continuing to search for a cell and gene therapy office leader.
Leqembi’s FSS Pricing Meets ICER’s Cost-Effectiveness Threshold; VA Requiring Coverage With Evidence
Eisai/Biogen Alzheimer’s treatment isn’t actually on the VA formulary, but Leqembi’s Federal Supply Schedule price, coming in at just over $20,000 annually, could address spending concerns.