PF-07976016 is under clinical development by Pfizer and currently in Phase I for Obesity. According to GlobalData, Phase I drugs for Obesity have a 59% phase transition success rate (PTSR) indication ...
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 ...
The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat individuals with mild cognitive impairment or mild dementia consistent with ...
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 ...
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 ...
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 ...
Acceptance of the Biologics License Application for subcutaneous Leqembi is based on results from the Clarity AD open-label extension and modeling of observed data in patients with Alzheimer disease.
If approved, subcutaneous autoinjector Leqembi will be the only Alzheimer's medication that can be administered at home. The FDA has set a goal date of Aug. 31, 2025. The FDA has accepted a biologics ...
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