The US approved an Alzheimer’s drug. Seven patients subsequently died.
Leqembi — sold through a partnership between Eisai Co. and Cambridge-based Biogen — is one of the first medications approved ...
BioPharma Dive1d
Leqembi’s EU review drags on; Sanofi gets a new development head
The European Commission has referred Eisai and Biogen’s application to an appeals committee. Elsewhere, Opthea warned of ...
BioPharma Dive6d
Lilly hits same Alzheimer’s roadblock in Europe as Eisai, Biogen
Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal ...
BIIB's Experimental Alzheimer's Drug Gets FDA Fast Track Tag
The FDA's fast track designation will facilitate rapid development and expedited review of Biogen's Alzheimer's disease ...
The European Commission refers lecanemab decision to Appeal Committee
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission (EC) has decided to refer ...
BioSpace6d
EU Rejects Lilly’s Alzheimer’s Drug Kisunla, Following Same Path as Rival Leqembi
The European Union’s CHMP said that the benefits of the drug, already approved in the U.S., do not outweigh the risk of ...
Devdiscourse6d
EU Regulators Reject Eli Lilly's Alzheimer's Drug: A Risky Decision?
The European Medicines Agency committee declined to approve Eli Lilly's Alzheimer’s treatment, citing risks of brain bleeding ...
Fierce Pharma6d
Eli Lilly's Alzheimer's contender Kisunla gets thumbs-down from EU regulators over safety concerns
After failing to pass muster with England’s drug reimbursement watchdog earlier this month, Eli Lilly’s Alzheimer’s disease ...
Morningstar2d
The European Commission refers lecanemab decision to Appeal Committee
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his ...
pharmaphorum22h
Eisai sets Leqembi price in Japan at a discount to US
Eisai and Biogen’s Alzheimer’s disease therapy Leqembi is due to be launched in Japan, its second market, on 20th December, and will be priced quite a lot lower there than in the US.
Pharmabiz1d
Eisai & Biogen update on regulatory review of MAA for lecanemab for early Alzheimer’s disease by the European Commission
Eisai & Biogen update on regulatory review of MAA for lecanemab for early Alzheimer’s disease by the European Commission: Tokyo Wednesday, April 2, 2025, 16:00 Hrs [IST] Eisai C ...