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Jan 6, 2023

FDA Approves LEQEMBI™ (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease

Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with LEQEMBI™ Treatment with LEQEMBI should be initiated in patients with...
Dec 19, 2022

EISAI TO DIVEST RIGHTS FOR ANTI-EPILEPTIC DRUG FYCOMPA® (perampanel) CIII IN UNITED STATES TO CATALYST PHARMACEUTICALS

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has entered into an agreement to transfer the United States (U.S.) commercial rights for the...
Nov 29, 2022

ELEVEN EXPERTS FROM LEADING MEDICAL INSTITUTIONS AND EIGHT EXPERTS FROM EISAI* PUBLISH FULL RESULTS OF LECANEMAB PHASE 3 CONFIRMATORY CLARITY AD STUDY FOR EARLY ALZHEIMER'S DISEASE IN THE NEW ENGLAND JOURNAL OF MEDICINE

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")...
Nov 29, 2022

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. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")...
Nov 20, 2022

EISAI TO PRESENT FULL FINDINGS FROM LECANEMAB CONFIRMATORY PHASE 3 CLINICAL TRIAL (CLARITY AD) AND OTHER ALZHEIMER'S DISEASE RESEARCH AT THE 15TH CLINICAL TRIALS ON ALZHEIMER'S DISEASE (CTAD) CONFERENCE

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") will present the efficacy, safety and biomarker findings from the company's Phase 3 confirmatory Clarity AD clinical trial for...
Sep 27, 2022

Lecanemab Confirmatory Phase 3 CLARITY AD Study Met Primary Endpoint, Showing Highly Statistically Significant Reduction Of Clinical Decline In Large Global Clinical Study Of 1,795 Participants With Early Alzheimer's Disease

ALL KEY SECONDARY ENDPOINTS ALSO MET, DEMONSTRATING HIGHLY STATISTICALLY SIGNIFICANT RESULTS PROFILE OF AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA) INCIDENCE WAS WITHIN EXPECTATIONS EISAI AIMS TO...
Aug 23, 2022

C2N and Eisai Collaborate to Build Awareness and Real-World Evidence for Blood-Based Assays for Cognitive Impairment in Clinical Practice Outside of Clinical Trial Settings

C2N Diagnostics and Eisai Inc. today announced the Companies have entered into a memorandum of understanding that will seek to build awareness about how blood-based assays for cognitive...
Aug 3, 2022

Eisai Presents New Findings On Lecanemab's Investigational Subcutaneous Formulation And Modeling Simulation Of APOE4 Genotype On ARIA-E Incidence At The Alzheimer's Association International Conference (AAIC) 2022

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced that...
Jul 25, 2022

Eisai To Present The Latest Lecanemab Data, Including ARIA-E And Subcutaneous Formulation, And Other Alzheimer's Disease Research At The Alzheimer's Association International Conference (AAIC) 2022

Eisai Co. Ltd (Headquarters: Toyoko, CEO: Haruo Naito, "Eisai") announced today that the company will present research from its Alzheimer's disease (AD) pipeline, including new data for lecanemab...
Jul 25, 2022

AB-related Paper Published in the American Scientific Journal Science

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that lecanemab, an anti-amyloid-β protofibril antibody being developed by Eisai, has no connection regarding...
Jul 5, 2022

The U.S. FDA Accepts and Grants Priority Review for Eisai's Biologics License Application of Lecanemab for Early Alzheimer's Disease Under the Accelerated Approval Pathway

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...
Jun 21, 2022

Eisai Publishes Potential Economic Value of Investigational Lecanemab in Peer-Reviewed Neurology and Therapy Journal

Second Publication on the Potential Value of Lecanemab in Patients with Early Alzheimer's Disease Using Simulation Modeling

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced publication of results from an early phase evaluation that aimed to estimate potential economic value of its...
Jun 2, 2022

Eisai to Present Latest Data on LEMBOREXANT at the 36th Annual Sleep 2022 Meeting

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today a total of seven poster presentations including the latest data on its in-house discovered orexin receptor...
May 9, 2022

Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application Of Lecanemab For Early Alzheimer's Disease Under the Accelerated Approval Pathway

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...
Apr 26, 2022

Long-term Health Outcomes Using Simulation Model of Investigational Lecanemab in Patients with Early Alzheimer's Disease Published in a Peer-Reviewed Journal, Neurology and Therapy

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") today announced an article about long-term health outcomes of its investigational anti-amyloid-beta (Aβ) protofibril antibody...
Apr 7, 2022

Eisai Statement on The Centers For Medicare And Medicaid Services’ National Coverage Determination with Coverage with Evidence Development for Monoclonal Antibodies Directed Against Amyloid for the Treatment Of Alzheimer’s Disease

Eisai stands with people living with Alzheimer’s disease (AD), health care professionals and other members of our AD community. We respect that the Centers for Medicare and Medicaid Services...
Apr 4, 2022

Geisinger, Eisai team up to study use of artificial intelligence for early detection and identification of cognitive impairment that could indicate dementias, including Alzheimer's disease

Research collaboration will test novel algorithm's effectiveness on Geisinger data DANVILLE, Pa. and NUTLEY, N.J., April 4, 2022 /PRNewswire/ -- Geisinger and Eisai Inc. today announced a...
Mar 31, 2022

Eisai to Present Data on Neurology Portfolio in the Areas of Alzheimer's Disease, Sleep and Epilepsy at the 74th American Academy of Neurology® (AAN) Annual Meeting

Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today the company will present research from its robust neurology portfolio, including the findings on lecanemab, an...
Mar 22, 2022

Sysmex Presents Academic Report in Effort to Create a Simple Blood Test to Diagnose Alzheimer's Disease

The Content Presented at the International Conference on Alzheimer's & Parkinson's Diseases: (AD/PD™ 2022) KOBE, Japan and TOKYO, March 22, 2022 /PRNewswire/ -- Sysmex Corporation (Chairman and CEO:
Mar 21, 2022

Latest Findings on Lecanemab - Clinical Efficacy, ARIA Rates, Biomarkers Relationship to Clinical Outcomes and Dosing Regimens - Presented At AD/PD™ 2022 Annual Meeting

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...
Mar 14, 2022

Biogen and Eisai amend collaboration agreements on Alzheimer’s disease treatments

Aducanumab collaboration to convert from Eisai sharing of global profits and losses to a global royalty arrangement, effective January 1, 2023. Lecanemab collaboration to continue unchanged globally. Lecanemab supply agreement to extend to 10 years from 5 years for commercial manufacturing by Biogen. Both companies will continue to collaborate together with the goal of bringing more options to patients and maximizing the value of both products

CAMBRIDGE, Mass., and TOKYO, March 14, 2022: Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) announced today that the companies have amended their existing collaboration agreement on...
Mar 10, 2022

Eisai To Present New Lecanemab Data Exploring Distinct Mechanism of Action and Clinical Outcomes, Disease State Symposium, and Other Pipeline Assets at the AD/PD™ 2022 Annual Meeting

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today the company will present research from its robust Alzheimer's disease (AD) pipeline, including the latest findings...
Mar 3, 2022

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. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today...
Feb 9, 2022

Eisai Submits Formal Comments to the Centers for Medicare and Medicaid Services’ Proposed National Coverage Determination with Coverage with Evidence Development for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai“) announced today that, as part of the public comment period, its U.S. subsidiary, Eisai Inc., has submitted formal comments...
Jan 27, 2022

Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM®

Cambridge, Mass. – January 27, 2022– Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced additional details about the Phase 4 post-marketing confirmatory study,...

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