Nasdaq

Eisai and Biogen Provide Update on Lecanemab Regulatory Review for Alzheimer’s Disease in the European Union

Eisai and Biogen update on lecanemab's EU regulatory review for early Alzheimer’s disease treatment following positive CHMP opinion. Eisai Co., Ltd. and Biogen Inc. have provided an update on the ...
Seeking Alpha

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. (BIIB) (Nasdaq ...

Update on FDA Priority Review of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer’s Disease

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License ...

FDA Extends Review of Eisai, Biogen Alzheimer’s Drug

The agency pushed its decision on weekly subcutaneous LEQEMBI IQLIK for early Alzheimer's initial treatment to Aug. 24 after ...
Nasdaq

Eisai : Lecanemab Receives Priority Review Status In Japan For Alzheimer's Disease Treatment

(RTTNews) - Eisai Co., Ltd. and Biogen Inc. (BIIB) said that an application for manufacturing and marketing approval for an anti-amyloid-ß (Aß) protofibril antibody, lecanemab (generic name, U.S.
Yahoo

When will lecanemab be available? Eisai and Biogen Alzheimer's drug awaits FDA approval

Add Yahoo as a preferred source to see more of our stories on Google. Federal drug regulators will decide by July 6 whether to grant the first traditional approval to an amyloid-busting drug to treat ...
Seeking Alpha

EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER'S DISEASE IN EUROPE

Jan. 10, 2023 6:30 PM ETBiogen Inc. (BIIB), ESALY Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting ...
Morningstar

Latest data on long-term, real-world treatment with lecanemab will be presented at the AD/PD™ 2026 congress

STOCKHOLM, March 11, 2026 /PRNewswire/ -- BioArctic's AB (publ) (STOCKHOLM: BIOA B) partner Eisai announced today that they will present the latest findings on lecanemab at the 2026 International ...
Monthly Prescribing Reference

Eisai Seeks Traditional Approval With New Lecanemab Data Under FDA Review

Credit: Getty Images. The sBLA is supported by data from the confirmatory phase 3 Clarity AD trial, which included patients with early Alzheimer disease. The Food and Drug Administration (FDA) has ...
FOX31 Denver

EISAI TO PRESENT NEW LECANEMAB DATA, INCLUDING RESEARCH EVALUATING SAFETY PROFILE, CLINICAL OUTCOMES AND QUALITY OF LIFE MEASURES, AS WELL AS OTHER ...

Presentations Explore ARIA with the Use of Antiplatelets or Anticoagulants and Isolated ARIA-H in Patients from Eisai's Lecanemab Phase 3 Confirmatory Clarity AD Study in Early Alzheimer's Disease ...
KOLR10 & Ozarks Local News

Eisai publishes societal value of lecanemab using phase 3 Clarity AD data in peer-reviewed Neurology and Therapy journal

STOCKHOLM, March 20, 2023 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai today announced the publication of updated results from an evaluation estimating the societal ...