Eisai Inc.
Global Headquarters:
4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088 Japan
US Headquarters: 100 Tice Blvd.
Woodcliff Lake
New Jersey
07677
United States
465 articles with Eisai Inc.
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Eisai publishes additional detailed analyses from lecanemab phase 2b study
3/31/2023
BioArctic AB's partner Eisai announced the publication of additional detailed analyses from the phase 2b clinical study, evaluating the efficacy and safety of lecanemab for mild cognitive impairment due to Alzheimer's disease and mild AD.
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Eisai Presented New Analyses of ARIA and QOL on Lecanemab in Clarity AD at the AD/PD™ 2023 Annual Meeting
3/30/2023
Eisai Co., Ltd. and Biogen Inc. announced that Eisai presented new analyses on amyloid-related imaging abnormalities with the use of antiplatelet and anticoagulant medications, isolated ARIA-H, and caregiver burden and health-related quality of life, from the results of Eisai’s Phase 3 Clarity AD study of lecanemab, an anti-amyloid-β protofibril* antibody, at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases annual meeting AD/PD™.
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BIIB080 successfully reduced tau pathology in patients with early-stage disease across all six brain regions analyzed.
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Additional Detailed Analyses From Phase 2 Study 201 of Lecanemab Published as Three Papers in Peer-Reviewed Journals
3/30/2023
Eisai Co., Ltd. and Biogen Inc. announced that three additional detailed analyses from the Phase IIb clinical study, evaluating the efficacy and safety of lecanemab for mild cognitive impairment due to Alzheimer’s disease and mild AD, were published in the peer-reviewed journals.
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Eisai to Present Research from Oncology Portfolio at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women's Cancer
3/23/2023
Eisai will present two abstracts at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women's Cancer (#SGOMtg), which is taking place in-person in Tampa, Florida and virtually from March 25-28.
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Eisai to Present New Lecanemab Data, Including Research Evaluating Safety Profile, Clinical Outcomes and Quality of Life Measures, as Well as Other Important Alzheimer's Disease Research, at the AD/PD™ 2023 Annual Meeting
3/22/2023
Eisai Co., Ltd. announced the company will present the latest findings on lecanemab, Eisai's anti-amyloid beta protofibril* antibody for the treatment of Alzheimer's disease, at the 2023 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders from March 28-April 1 in Gothenburg, Sweden and virtually.
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Eisai Publishes Societal Value of Lecanemab Using Phase 3 Clarity Ad Data in Peer-reviewed Neurology and Therapy Journal
3/19/2023
Eisai Co., Ltd. announced the publication of updated results from an evaluation estimating the societal value of anti-amyloid-beta protofibril* antibody lecanemab in people living with mild cognitive impairment due to Alzheimer's disease and mild AD using data from the Phase 3 clinical study, Clarity AD by applying a validated disease simulation model.
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The FDA set a decision date of July 6, 2023 for Eisai and Biogen’s recently approved Alzheimer’s drug, Leqembi, Eisai announced Monday.
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FDA accepts sBLA for traditional approval of LEQEMBI™ (lecanemab-irmb) for the treatment of Alzheimer's disease and grants Priority Review: BioArctic
3/6/2023
BioArctic AB's partner Eisai announced that the U.S. Food and Drug Administration has accepted Eisai's supplemental Biologics License Application for LEQEMBI™ 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval.
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FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
3/5/2023
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration has accepted Eisai’s supplemental Biologics License Application for LEQEMBI™ 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval.
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Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration
2/27/2023
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.
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If Leqembi is granted priority review from the agency, full approval could come as soon as July, Ivan Cheung, chairman and CEO, Eisai Inc., told CNBC Thursday.
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Lecanemab Receives Priority Review Status in Japan
1/29/2023
Eisai Co., Ltd. and Biogen Inc. announced that an application for manufacturing and marketing approval for lecanemab, an anti-amyloid-β protofibril* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare.
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Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency
1/26/2023
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI™).
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The FDA's approval of Biogen and Eisai's Leqembi and subsequent decision not to approve Eli Lilly's donanemab have sparked debate anew about the anti-amyloid theory in Alzheimer's.
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The neurodegenerative drug development space saw incremental victories in 2022. Leaders from Eisai, Voyager and QurAlis discuss upcoming milestones.
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Eisai Aims to Advance Gastrointestinal Cancer Treatment with Research Across Multiple Tumor Types at ASCO GI 2023
1/18/2023
Eisai announced today the presentation of research across various types of gastrointestinal cancers during the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI23), which is taking place in-person in San Francisco, California and virtually from January 19-21.
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Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer's Disease in Japan
1/16/2023
Eisai Co., Ltd. and Biogen Inc. announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril1 antibody for the treatment of mild cognitive impairment due to Alzheimer's disease and mild AD dementia with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency.
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BioArctic's partner Eisai submits marketing authorization application for lecanemab as treatment for early Alzheimer's disease in Japan
1/16/2023
BioArctic AB's partner Eisai announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril[1] antibody for the treatment of mild cognitive impairment due to Alzheimer's disease and mild AD dementia with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency.
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BioArctic's partner Eisai submits marketing authorization application for lecanemab as treatment for early Alzheimer's disease in the EU
1/11/2023
BioArctic AB's partner Eisai announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early Alzheimer's disease and mild AD dementia) to the European Medicines Agency.