Biogen Stock Down on Regulatory Update in the EU for Alzheimer's Drug
The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...
BioSpace22h
As US Sales of Leqembi Lag, Eisai Eyes SubQ Approvals
The FDA last month accepted the application for subcutaneous Leqembi for maintenance dosing, with a target action date of ...
Nasdaq4d
Biogen Stock Down on Regulatory Update in the EU for Alzheimer's Drug
Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the approval of Leqembi (lecanemab) for mild cognitive impairment due to ...
pharmaphorum1d
In shock move, EU panel rejects Alzheimer's drug Leqembi
The EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China, and Japan gave a green light to ...
Pharmabiz5d
BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU
BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU: Stockholm Monday, February 3, 2025, 13:00 Hrs [IST] BioA ...
The Pharma Letter5d
BRIEF—EC calls for update on regulatory review of lecanemab
Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early ...