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.
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.
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.
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
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.
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 mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD) in the European Union.
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
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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 ...
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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 ...
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 ...
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Eisai and Biogen gain FDA approval for monthly Leqembi
Eisai and Biogen have secured US Food and Drug Administration approval for a once-monthly intravenous maintenance dosing ...
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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 ...
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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 ...