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Eu, Eisai and Biogen

Europe to review safety data for Eisai-Biogen Alzheimer's drug

The European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi, nearly three months after it recommended approval for the drug to treat some patients with early Alzheimer's disease.

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 · 6d

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 ...

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 ...

Nasdaq2d

Biogen And Eisai Update On Lecanemab's EU Regulatory Review

(RTTNews) - Biogen Inc. (BIIB), a biotechnology company and Eisai Co., Ltd. On Friday provided an update on the regulatory review of lecanemab as a treatment for early Alzheimer's disease or AD in ...

Yahoo Finance2d

Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union

“Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today an update on the ongoing regulatory ...

pharmaphorum2d

EMA experts will look again at Leqembi's safety data

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...

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