The constraint has been a lack of good drugs to treat those patients. Eisai and Biogen, with Leqembi, and Eli Lilly, with Kisunla, have begun the process of establishing a drug arsenal for ...
BioArctic AB (publ) announced that the US Food and Drug Administration (FDA) has accepted BioArctic’s partner Eisai’s Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) ...
Jan 15, 2025 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for ...
However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “number of catalysts” that could accelerate Leqembi’s growth in 2025. Since its approval in 2023, the launch of the ...
The FDA has accepted Eisai and Biogen’s biologics license application for a subcutaneous autoinjector weekly maintenance dose of Leqembi for patients with mild cognitive impairment or mild ...
Biogen Hits Lowest Stock Price Since 2013 as Leqembi Uptake Lags Biogen CEO Chris Viehbacher at JPM25 said that the pharma remains fully committed to the Alzheimer’s disease space and its therapeutic ...
Charles Riv­er Lab­o­ra­to­ries is pre­dict­ing 2025 to be as tough as last year for CD­MOs as phar­ma cus­tomers con­tin­ue to cut costs with man­u­fac­tur­ers. … ...
Two years ago, Biogen and partner Eisai secured accelerated FDA approval for their Alzheimer’s med Leqembi, followed by a full approval in 2023. Since then, the companies have been gradually ...
On Monday, the FDA accepted Eisai Co., Ltd. (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI ...
FDA sets August 31, 2025, as the action date for Eisai and Biogen's Leqembi subcutaneous autoinjector application. Leqembi's subcutaneous dosing allows Alzheimer's patients to administer weekly ...
Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment Leqembi (lecanemab-irmb) after the US Food and Drug Administration ...
LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease. A Prescription Drug User Fee Act (PDUFA ...