Keeping Track: Biogen’s Aducanumab Headlines Midsummer Submission Round-Up
The latest application submission news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Biogen's Aducanumab Advisory Committee Will Test US FDA's 'Substantial Evidence' Flexibility
Given inconsistent study results, robustness of the efficacy evidence is expected to be key focus of the 6 November meeting of the Peripheral and Central Nervous System Drugs Advisory Committee; review could put a December 2019 guidance on the ‘substantial evidence’ standard to the test and offer insight into the amount of flexibility the agency is willing to exercise for neurodegenerative diseases with high unmet need.
Adu-CAN-umab? Reading The Tea Leaves For Biogen’s US Filing For Alzheimer’s Drug
The US Food and Drug Administration is expediting the review for Biogen’s Alzheimer’s therapy aducanumab, setting up a likely November/December advisory committee consideration that in normal times would be the dominant topic for those who care about the agency.