Eisai Company, Ltd.
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349 articles with Eisai Company, Ltd.
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) announced today that the companies have amended their existing collaboration agreement on aducanumab, which is commercialized in the United States as ADUHELM® (aducanumab-avwa).
EISAI INITIATES SUBMISSION OF APPLICATION DATA UNDER THE PRIOR ASSESSMENT CONSULTATION SYSTEM IN JAPAN WITH THE AIM OF OBTAINING EARLY APPROVAL FOR INVESTIGATIONAL ANTI-AMYLOID BETA PROTOFIBRIL ANTIBODY LECANEMAB
Eisai Co., Ltd. announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401).
Clinical trial news definitely picked up this final week of January. Here’s a look.
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced additional details about the Phase 4 post-marketing confirmatory study, ENVISION, of ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease, including details of the study’s goal for diverse enrollment and primary endpoint.
Biogen and its partner Eisai Company released additional details about the Phase IV post-marketing study of the drug.
FIRST SUBJECT ENROLLED IN PHASE II/III STUDY OF EISAI'S ANTI-MTBR TAU ANTIBODY E2814 FOR DOMINANTLY INHERITED ALZHEIMER'S DISEASE (DIAD), CONDUCTED BY DIAN-TU
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has enrolled the first subject in the phase II/III study (Tau NexGen study).
Eisai Co., Ltd. and Biogen Inc. announced today that lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer was granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
Japan’s First Committee on New Drugs of The Pharmaceutical Affairs and Food Sanitation Council Seeks Additional Data; Aducanumab Remains under Review
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council that advises the Ministry of Health, Labour and Welfare (MHLW) in Japan has decided to continue deliberations on the application for the manufacturing and marketing approval of aducanumab for the treatment of Alzheimer’s disease.
Update on Regulatory Submission for Aducanumab in the European UnionBiogen to seek re-examination following CHMP negative opinion for aducanumab
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application (MAA) for aducanumab.
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today provided an important update on the continuing progress of the Phase 4 post-marketing confirmatory study of ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in Alzheimer’s disease.
Eisai Presents New Data on the Relationship between Clinical, Biomarker and Safety Outcomes from the Lecanemab Phase 2b Study for Early Alzheimer's disease
Eisai Co., Ltd. (Headquarters: Tokyo , CEO: Haruo Naito , "Eisai") announced today the presentation of data from the company's extensive Alzheimer's disease (AD) pipeline, including six oral presentations that will provide deeper insights into lecanemab's potential as a treatment for early AD.
Eisai Initiates Rolling Submission To The U.S. FDA For Biologics License Application Of Lecanemab (BAN2401) For Early Alzheimer's Disease Under The Accelerated Approval Pathway
Eisai Co., Ltd. today announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab
Biogen agreed to pay $22 million in response to allegations that it violated the False Claims Act, and now, life insurance company Humana is suing Biogen over a similar scheme.
FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease
Biogen and Eisai, Co., Ltd. announced that the U.S. Food and Drug Administration has granted accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain.
Biogen and Eisai launch multiple initiatives to help patients with Alzheimer’s disease access ADUHELM™
Collaborations with Veterans Health Administration, CVS Health and NAFC focused on health disparities in underserved communities
Hackensack Meridian Health and Eisai Inc. Join Forces to Support the Expansion of Alzheimer's Disease Detection and Services for Patients
Hackensack Meridian Health, New Jersey's largest, most comprehensive and integrated health network, and Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., have entered into a research collaboration agreement that initially aims to help address the significant unmet needs of people living with Alzheimer's disease, especially those experiencing the earliest stages of the disease, known as Mild Cognitive Impairment.
Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab
Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease
Biogen and Eisai, Co., Ltd. announced that Biogen has submitted a Japanese New Drug Application to the Ministry of Health, Labor and Welfare for aducanumab, an investigational therapy for Alzheimer’s disease.
Eisai and Wren Therapeutics Enter Into Research Collaboration Agreement for Drug Discovery for Synucleinopathies
This collaboration aims to develop a disease modifying treatment for synucleinopathies based on network kinetics of α-synuclein misfolding and aggregation
European Medicines Agency Accepts Biogen’s Aducanumab Marketing Authorization Application for Alzheimer's Disease
If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease andto meaningfully change the course of Alzheimer’s disease