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Latest From Sage Therapeutics, Inc.
Keeping Track: Lilly’s Mounjaro Enters Diabetes Market; Biogen/Eisai Lecanemab Leads Neuroscience News
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.
Lecanemab is now filed for accelerated approval with the US FDA, but the wait for a Phase III readout could impact the hunt for Biogen’s next CEO.
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.
The company will prioritize later-stage R&D, including potential accelerated approval for a second anti-amyloid antibody, while replacing its CEO and cutting Aduhelm commercial operations and other costs.
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