CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE„ to the reference product ROACTEMRA® CAMBRIDGE, Mass., April 25, 2024 (GLOBE...
The partners are sharing materials, which describe details such as Leqembi’s mechanism, via channels including physician office print and video.
If you thought that Eli Lilly's donanemab could ensure a smooth regulatory flight in the slipstream of Eisai and Biogen, the FDA has other ideas.
Eisai, Biogen`s subQ Leqembi delayed amid FDA`s data request
The team, led by Dr Jenna Gregory of the University of Aberdeen in Scotland, think that the test – which looks for specific protein clumps in brain tissue samples – could allow patients to receive treatment for MND at an earlier stage, when it may be more effective. It may also serve as a surrogate marker to test new therapies more quickly.
Indivi to Collaborate with Biogen to Advance Digital Health Technology
March 22 (Reuters) - The European Union's medicines regulator has delayed its decision on Eisai (4523.T), opens new tab and partner Biogen's (BIIB.O), opens new tab Alzheimer's disease drug that was expected this week, the Japanese company said on Friday.
Biogen to Participate in the Stifel 2024 Virtual CNS Days
Ever since the controversial approval of Biogen and Eisai's Aduhelm, debate has swirled around the strength of the link between amyloid reduction and the cognitive benefits of potential Alzheimer's disease treatments. The FDA appears to have stepped back into this arena as part of fresh updates to its guidance on these drugs.