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 ...
Zacks.com on MSN1h
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 ...
The Pharma Letter35m
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 ...
European regulators green light new Alzheimer's drug after first rejecting it
US regulators approved Leqembi in 2023 and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved the ...
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 ...
GlobalData on MSN21h
EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
AFP on MSN22h
European Watchdog Partially Approves New Alzheimer's Drug
Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer ...
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) ...
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 ...
DPA International on MSN20h
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 ...
JCN Newswire12h
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer's Disease
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ...