Is Biogen’s Aducanumab Approvable? Opinions Divided Ahead Of Review
FDA Committee Meets On 6 November
Many clinicians doubt that aducanumab can really help slow the decline in Alzheimer’s patients – but US FDA could offer it the benefit of the doubt.
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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.
Mylan’s “at-risk” launch of a generic version of Biogen’s Tecfidera could cost the originator dear as generic competition to the one of the most lucrative small-molecule opportunities arrives in the US.
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