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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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| Friday, January 13, 2023 |
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Eisai Launches Renewed Sustainability Page |
| Eisai Co., Ltd. announced that it has renewed the Sustainability page of its corporate website and it is now accessible to the public. more info >> |
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| Wednesday, January 11, 2023 |
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Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease in Europe |
| Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted 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) to the European Medicines Agency (EMA). more info >> |
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| Monday, January 9, 2023 |
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Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease |
| Eisai Co., Ltd. and Biogen Inc. announced Eisai has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) supporting the conversion of the Accelerated Approval of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use to a traditional approval. more info >> |
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FDA Approves LEQEMBI (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease |
| Eisai Co., Ltd. and Biogen Inc. announced today that under the Accelerated Approval Pathway the U.S. Food and Drug Administration (FDA) has approved lecanemab-irmb (Brand Name in the U.S.: LEQEMBI) 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ("protofibril")* and insoluble forms of amyloid beta (Abata) for the treatment of Alzheimer's disease (AD). more info >> |
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