Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...
Eisai receives positive CHMP opinion for Lecanemab in early Alzheimer’s disease
Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...
Eisai Gets Positive Opinion From CHMP In European Union For Lecanemab In Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...
Pharmabiz15h
EMA committee recommends approval of Eisai & Biogen’s lecanemab to treat early Alzheimer’s disease
EMA committee recommends approval of Eisai & Biogen’s lecanemab to treat early Alzheimer’s disease: Tokyo Saturday, November 16, 2024, 13:00 Hrs [IST] Eisai Co., Ltd. and Biog ...
CHMP Issues Positive Recommendation For Approval Of Lecanemab In The EU
The CHMP recommends approval of lecanemab for the treatment of mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's disease, in adult patients who are heterozygotes (carry one copy) ...
Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe
The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...
European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
DPA International on MSN2d
EU regulator reverses decision to block Alzheimer's drug lecanemab
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...
Medscape1d
Leqembi Okayed for Subset of Early Alzheimer’s Patients
The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene ...
Ticker: Biogen Alzheimer’s drug gets second look in EU; Ford takes $165M hit on slow recall
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
Nasdaq8d
Eisai updates Leqembi® outlook for fiscal year 2024 (April 2024 - March 2025). Sales now expected to reach JPY 42.5 billion
BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and Eisai and BioArctic are currently preparing for a joint commercialization in the region.
Eisai completes rolling BLA submission for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug ...