Biogen, Eisai and Leqembi

Biogen, Eisai Win Nod for Monthly Leqembi Maintenance Amid Stagnant Sales
The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for patients with Alzheimer’s, could help with Leqembi’s thus far disappointing uptake and sales.
Biogen, Eisai: EC Asks CHMP to Take Another Look at Leqembi
Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration in 2023 approved Leqembi, which is also approved in the U.K., Japan, China and several other countries.
Eisai and Biogen’s Leqembi sBLA set for Alzheimer’s maintenance dosing
The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's Leqembi (lecanemab-irmb) for maintenance dosing once every four weeks for the early stages of Alzheimer's disease.
Biogen, Eisai receive FDA nod for monthly Leqembi IV maintenance dosing
The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.
Biogen, Eisai Get FDA Nod for Leqembi IV Maintenance Dosing
Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA approved the maintenance dosing of once every four weeks after 18 months of the initiation phase of once every two weeks.
FDA approves Eisai, Biogen’s sBLA for lecanemab-irmb IV dosing
Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License
FDA approves Leqembi four-week maintenance dosing
The FDA has approved Eisai (OTCPK:ESALF) and Biogen's (NASDAQ:BIIB) supplemental application for four-week maintenance dosing of their Alzheimer's drug Leqembi. The agency approved Leqembi to be dosed every four weeks via IV as a maintenance therapy.
Europe to review safety data for Eisai-Biogen Alzheimer's drug
The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...
Biogen, Eisai Alzheimer’s drug review delayed in EU
Biogen (BIIB) stock in focus as company and partner Eisai (ESALF) face delay in the EU launch of Alzheimer's drug lecanemab.
Biogen provides update on EU regulatory review of lecanemab in Alzheimer’s
Biogen (BIIB) and Eisai announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as ...
US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug
The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's ...
Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: ...
Update on regulatory review of lecanemab for treatment of early Alzheimer's disease in the European Union
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee ...
devdiscourse3d
Health News Highlights: Breakthroughs, Rejections, and Strategies
In recent health developments, Akero Therapeutics' drug shows promise for liver disease, Eisai/Biogen's Alzheimer's drug ...
American Association of Individual Investors19h
Which Is a Better Investment, Biogen Inc. or Natera, Inc. Stock?
Learn more about whether Biogen Inc. or Natera, Inc. is a better investment based on AAII's A+ Investor grades, which compare both companies' key financial metrics.