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Keeping Track: Lilly’s Mounjaro Enters Diabetes Market; Biogen/Eisai Lecanemab Leads Neuroscience News

Executive Summary

CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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Eisai/Biogen’s Lecanemab Faces Smoother Passage Through US FDA Than Aducanumb

With amyloid plaque reduction established as a surrogate endpoint by Aduhelm’s accelerated approval for Alzheimer’s disease, lecanemab is unlikely to face an advisory committee before its 6 January user fee goal date.

Eisai’s Lecanemab BLA Filing A Key Step For Ailing Biogen

Aduhelm commercialization was a bust, so Biogen’s next big hope for a potential blockbuster Alzheimer’s therapy is partner Eisai’s amyloid protofibril-targeting antibody lecanemab. 

Tirzepatide’s Glowing Obesity Data Steal Show On Lilly’s Earnings Call

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