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Biogen, EU and Eisai

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 Alzheimer's drug Leqembi, the agency said on Friday.

Bloomberg L.P. · 2d

EU to Weigh New Safety Data on Biogen, Eisai Alzheimer’s Drug

European Union regulators will review new information relating to the safety of Eisai Co.’s and Biogen Inc.’s medicine for Alzheimer’s disease, providing a response after a meeting next month.

Seeking Alpha on MSN · 2d

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. Read more here.

Reuters · 5d

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 Alzheimer's drug Leqembi, the companies said on Monday.

Business Insider · 2d

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

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 ...

9don MSN

Merck, Eisai's combination drug fails in late-stage trial for esophageal cancer

Merck and Japan-based Eisai said on Friday a combination of their therapies failed to extend the lives of patients with a ...

Hosted on MSN5d

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 ...

BioSpace6d

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 ...

ALZFORUM2d

Leqembi Maintenance Dosing Approved in the U.S.

The U.S. Food and Drug Administration approved Eisai and Biogen’s application for IV maintenance dosing of lecanemab on January 27. Previously, the label called for biweekly IV dosing. The new ...