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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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 ...
The Pharma Letter6d
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 ...
The Pharma Letter3h
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 ...