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Press Releases |
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Monday, March 6, 2023 |
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FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease |
Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's supplemental Biologics License Application (sBLA) for LEQEMBITM (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval. more info >> |
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Thursday, March 2, 2023 |
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Biogen Japan and Eisai Provide Update on Co-Promotion Of Multiple Sclerosis Treatments In Japan |
Biogen Japan Ltd. and Eisai Co., Ltd. announced today the termination of the co-promotion agreement that has been in place since January 2018 for Biogen Japan's multiple sclerosis (MS) treatments TECFIDERA (dimethyl fumarate), TYSABRI (natalizumab, genetic recombinant) and AVONEX (interferon beta 1a, genetic recombinant) in Japan as of March 31, 2023. more info >> |
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Tuesday, February 28, 2023 |
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Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration |
Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. more info >> |
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Tuesday, February 21, 2023 |
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Dissolution of Bracco-Eisai Joint Venture |
Bracco Imaging S.p.A. and Eisai Co., Ltd. announced today that the joint venture regarding the company Bracco-Eisai Co., Ltd. (Ratio of Shares Held: Bracco 51% Eisai 49%), will be dissolved as of March 31, 2023. more info >> |
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Monday, January 30, 2023 |
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Lecanemab Receives Priority Review Status in Japan |
Eisai Co., Ltd. and Biogen Inc. announced today that an application for manufacturing and marketing approval for lecanemab (generic name, U.S. brand name: LEQEMBI), an anti-amyloid-beta (Abeta) protofibril* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare (MHLW). more info >> |
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Friday, January 27, 2023 |
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Eisai: Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease Accepted by European Medicines Agency |
Eisai Co., Ltd. and Biogen Inc. announced today that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab, an investigational anti-amyloid beta (Abeta) protofibril* antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) with confirmed amyloid pathology, for review following a standard timeline. more info >> |
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Thursday, January 19, 2023 |
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Eisai Commences Business Activities at New Pharma Sales Subsidiary in Israel |
Eisai Co., Ltd. announced today that fully-fledged operations and business activities have begun at Eisai Israel Ltd., a pharmaceutical sales subsidiary recently established in Tel Aviv in the State of Israel (Israel). more info >> |
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Eisai Listed as a Global 100 Most Sustainable Corporation for The Seventh Time Highest Ranked Global Pharmaceutical Company |
Eisai Co., Ltd. announced that it has been listed in the 2023 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc. more info >> |
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Wednesday, January 18, 2023 |
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Eisai Aims to Advance Gastrointestinal Cancer Treatment with Research Across Multiple Tumor Types at ASCO GI 2023 |
Eisai Co., Ltd. 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. more info >> |
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Monday, January 16, 2023 |
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Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer's Disease in Japan |
Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a marketing authorization application for lecanemab. more info >> |
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