FiercePharma2d
CHMP again backs Leqembi amid flurry of approval recommendations
Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...
The Committee For Medicinal Products For Human Use (CHMP) Reaffirms Positive Opinion 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 ...
BioWorld3d
Leqembi gets another thumbs-up amid CHMP February recommendations
The EMA’s Committee for Medicinal products for Human Use (CHMP) is standing by its opinion on Leqembi (lecanemab) after the European .mission pushed back against a recommendation in November 2024 that ...
MarketWatch1mon
Biogen, Eisai: EC Asks CHMP to Take Another Look at Leqembi
The CHMP last July recommended against approval of Leqembi, citing safety and efficacy issues, but Biogen and Eisai asked the panel to take another look, and the CHMP in November reversed course ...
Hosted on MSN27d
Biogen Stock Down on Regulatory Update in the EU for Alzheimer's Drug
Image Source: Zacks Investment Research We remind the investors that the CHMP had earlier given a negative opinion regarding marketing approval for Leqembi for early Alzheimer's disease in July ...