Medscape19h
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 ...
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 ...
GlobalData on MSN1d
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.
The Pharma Letter19h
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 ...
Yahoo1d
European watchdog partially approves new Alzheimer's drug
"After re-examining its initial opinion, the EMA... has recommended granting marketing authorisation to Leqembi (lecanemab) ...
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 ...
Yahoo News UK7h
'Life changing' Alzheimer's drug is approved for use to reduce cognitive decline
Yes, although it's called something different. GOV.UK states that the Medicines and Healthcare products Regulatory Agency ...
ALZFORUM1d
Leqembi: Side Effects No Worse in Clinical Use Than They Were in Trial
An estimated 4,500 prescriptions have been filled in 2024 so far, Iwatsubo said. About 80 percent of patients have mild cognitive impairment, the rest have mild dementia. Most are in their 70s, and ...
CHMP issues positive recommendation for approval of lecanemab in the EU
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued ...
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 ...
The Pharma Letter4d
BRIEF—Eisai updates Leqembi outlook
Sweden-based BioArctic saw its fall 7.5% to 139.90 kronor on Friday, after its announced that its partner, Japan’s Eisa, has updated its revenue outlook for the Alzheimer’s treatment Leqembi ...