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Biogen Inc.: FDA Accepts Eisai's Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease

TOKYO and CAMBRIDGE, Mass., June 09, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts
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Eisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI® (lecanemab-irmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status

TOKYO and CAMBRIDGE, Mass., May 14, 2024 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has initiated the rolling submission of a Biologics License Application to the...
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KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Receive Public Listing for Patients with Advanced Endometrial Carcinoma (EC) that is not MSI-H or dMMR

KIRKLAND, QC, and MISSISSAUGA, ON, Dec. 21, 2023 /CNW/ - Merck , known as MSD outside the United States and Canada, and Eisai announce that KEYTRUDA®, Mercks anti-PD-1 therapy, plus LENVIMA®, an...
New Zealand United States United Kingdom Michele Randazzo Damini Chokshi Patrick Forsythe

Biogen : "LEQEMBI® Intravenous Infusion" (Lecanemab) for the Treatment of Alzheimer's Disease to be Launched in Japan on December 20 -December 12, 2023 at 09:19 pm EST

TOKYO and CAMBRIDGE, Mass., December 12, 2023 - Eisai Co., Ltd. and Biogen Inc. announced today that humanized anti- soluble aggregated amyloid-beta monoclonal antibody LEQEMBI®...
United Kingdom United States New Zealand Great Britain Christophera Viehbacher Jack Cox

Eisai Presents New LEQEMBI® (lecanemab-irmb) Investigational Subcutaneous Formulation Interim Study Results and Clinical Improvement Data in Earlier Stages of Early Alzheimer's Disease From Additional Analyses of Clarity AD at The Clinical Trials On Alzheimer's Disease (CTAD) Conference -October 25, 2023 at 05:27 pm EDT

Investigational Subcutaneous Formulation Clears 14% More Plaque Than IV, Pharmacokinetics 11% Higher, And Similar ARIA Rates To IV 76% Of Patients Showed No Decline And 60% Showed Clinical...
United States South Korea United Kingdom New Zealand Great Britain Acta Pharmacol

EISAI PRESENTS NEW LEQEMBI® (LECANEMAB-IRMB) INVESTIGATIONAL SUBCUTANEOUS FORMULATION INTERIM STUDY RESULTS AND CLINICAL IMPROVEMENT DATA IN EARLIER STAGES OF EARLY ALZHEIMER'S DISEASE FROM ADDITIONAL ANALYSES OF CLARITY AD AT THE CLINICAL TRIALS ON ALZHEIMER'S DISEASE (CTAD) CONFERENCE

INVESTIGATIONAL SUBCUTANEOUS FORMULATION CLEARS 14% MORE PLAQUE THAN IV, PHARMACOKINETICS 11% HIGHER, AND SIMILAR ARIA RATES TO IV 76% OF PATIENTS SHOWED NO DECLINE AND 60% SHOWED CLINICAL...
United States South Korea New Zealand United Kingdom Great Britain Christophera Viehbacher

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