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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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Thursday, December 22, 2022 |
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Astellas, Eisai, Daiichi Sankyo and Takeda Agree to Collaborate to Reduce Environmental Burden in the Field of Pharmaceutical Packaging |
Astellas Pharma Inc., Eisai Co., Ltd., Daiichi Sankyo Company, Limited and Takeda Pharmaceutical Company Limited. today announced that the four companies have agreed the collaboration to reduce environmental burden in the field of pharmaceutical packaging. more info >> |
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Tuesday, December 20, 2022 |
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Eisai to Divest Rights for Anti-Epileptic Drug Fycompa (perampanel) CIII in United States to Catalyst Pharmaceuticals |
Eisai Co., Ltd. announced today that it has entered into an agreement to transfer the United States (U.S.) commercial rights for the anti-epileptic drug (AED) Fycompa (generic name: perampanel) CIII to Catalyst Pharmaceuticals, Inc., as well as to provide Catalyst Pharmaceuticals with an exclusive negotiation period for an asset in Eisai's epilepsy pipeline. more info >> |
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Thursday, December 15, 2022 |
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Eisai and Washington University School of Medicine in St. Louis Enter Into Comprehensive Research Collaboration Agreement Aiming to Create New Therapies for Neurodegenerative Diseases |
Eisai Co., Ltd. announced today that Eisai and Washington University School of Medicine in St. Louis have entered into a comprehensive research collaboration agreement aiming to create potential novel treatments for neurodegenerative disorders, including Alzheimer's disease (AD) and Parkinson's disease (PD). more info >> |
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Thursday, December 1, 2022 |
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Eisai to Present Preclinical and Clinical Research on Eribulin at the 2022 San Antonio Breast Cancer Symposium |
Eisai Co., Ltd. announced today that new study results on its in-house discovered and developed anticancer agent eribulin mesylate (HALAVEN, "eribulin") will be presented during the 2022 San Antonio Breast Cancer Symposium (SABCS), which is taking place virtually and in-person in San Antonio, Texas from December 6-10. more info >> |
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Wednesday, November 30, 2022 |
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Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer's Disease at Clinical Trials on Alzheimer's Disease (CTAD) Conference |
Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab. more info >> |
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