Medscape1h
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 ...
The Pharma Letter48m
EMA/CHMP November recommendations include Leqembi U-turn
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November ...
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 ...
Zacks.com on MSN3h
Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe
Biogen Inc.’s BIIB Japan-based partner, Eisai announced that the European Medicines Agency’s (EMA) Committee for Medicinal ...
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 ...
Medpage Today on MSN3d
Alzheimer's Data Withdrawn
A preprint research letter linking the Alzheimer's drug lecanemab (Leqembi) with excess deaths was withdrawn last week. The ...
Yahoo Finance1d
CHMP issues positive recommendation for approval of lecanemab in the EU
The CHMP recommendation for the European Commission to approve lecanemab follows Eisai's request for a re-examination of the CHMP's earlier negative recommendation. A decision from the European ...
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 ...