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 European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi that the ...
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 ...
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 ...
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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 PR Newswire. To help healthcare journalists and consumers stay on top of the week's most ...
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BioArctic stock sinks on EU regulatory concerns
Despite the regulatory setback, BioArctic’s partner Eisai has stated that the safety profile of lecanemab reported in clinical practice in the United States, Japan, and other countries is consistent ...