Biogen, Eisai: EC Asks CHMP to Take Another Look at Leqembi
Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration ...
Europe to review safety data for Eisai-Biogen Alzheimer's drug
The review is conducted in response to a request from the European Commission, and may require the agency to update its ...
Update on regulatory review of lecanemab for treatment of early Alzheimer's disease in the European Union
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee ...
Weekly Roundup: 12 Health Press Releases You Need to See
With thousands of press releases published each week, it can be difficult to keep up with everything on . To help healthcare journalists and consumers stay on top of the week's most newsworthy and ...
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Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union
Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to ...
Voyager: Crossing The Blood-Brain Barrier, Competitors, And Investment Relevance
Financial writer recommends Voyager Therapeutics, Inc. for high-risk investors due to promising preclinical Alzheimer's ...
Biogen, Eisai Alzheimer’s drug review delayed in EU
Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) are expected to face another delay in launching their new Alzheimer's drug, lecanemab, in the EU after the European Commission on Friday asked the region's ...