Medscape9h
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 ...
FiercePharma1d
EMA changes tune, endorses Eisai and Biogen's Leqembi in restricted Alzheimer's population
Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | ...
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 Letter8h
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 ...
Business Insider18h
Positive EMA Reversal Boosts Biogen’s Leqembi Prospects Despite Challenges
Michael Yee has given his Buy rating due to a combination of factors including the recent positive developments regarding Biogen’s Alzheimer’s drug, Leqembi, in the European market. The European ...
BioSpace4d
Leqembi, Kisunla and Beyond: The Next Wave of Alzheimer’s at CTAD 2024
With Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla launching onto the market, the 2024 Clinical Trials of Alzheimer’s ...
devdiscourse1d
EU Gives Green Light: Leqembi on the Verge of Alzheimer's Approval
The EU's drugs regulator recommends approval of Eisai and Biogen's Alzheimer's drug, Leqembi, for patients with early stages ...
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 ...
STAT10h
CAR-T promising for autoimmune disease while perhaps preserving fertility
Why one trial participant's healthy birth after her CAR-T treatment for lupus is catching resesarchers' attention: ...
STAT1d
Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be ...
Eisai: Still Relatively Modest Market-Implied Expectations For Leqembi
Analysis of Leqembi's commercial potential and market outlook, with a focus on growth projections and investment ...