alzheimer’s – Singapura Now

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe

TOKYO, Jan 11, 2023 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due... » read more

polly written 2 months ago

Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

TOKYO, Jan 9, 2023 – (JCN Newswire via SEAPRWire.com) – 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. This... » read more

polly written 2 months ago

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

TOKYO, Nov 30, 2022 – (JCN Newswire via SEAPRWire.com) – 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 (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s... » read more

polly written 4 months ago

Eisai’s Sales Subsidiary Collaborates with Thai Life Insurance to Support Access to Treatments for Dementia, Including Alzheimer’s Disease, in Thailand

TOKYO, Nov 4, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that its Thai sales subsidiary Eisai (Thailand) Marketing Co. Ltd. (“Eisai Thailand”) made an agreement to collaborate in supporting access to treatments for dementia, including Alzheimer’s disease, in Thailand with Thai Life Insurance Public Company Limited, a leading life insurance... » read more

polly written 5 months ago

Eisai to Present at The Alzheimer’s Association International Conference (AAIC) 2022

TOKYO, Jul 26, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co. Ltd announced today that the company will present research from its Alzheimer’s disease (AD) pipeline, including new data for lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild... » read more

polly written 8 months ago

U.S. FDA Accepts and Grants Priority Review for Eisai’s Biologics License Application of Lecanemab

TOKYO, Jul 6, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild... » read more

polly written 9 months ago

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

TOKYO and CAMBRIDGE, Mass., May 10, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Abeta) protofibril antibody... » read more

polly written 11 months ago

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

TOKYO, Mar 11, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today the company will present research from its robust Alzheimer’s disease (AD) pipeline, including the latest findings on lecanemab, Eisai’s investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of early AD at the AD/PD 2022 International Conference on Alzheimer’s and... » read more

polly written 1 year ago

Eisai: Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM

Cambridge, MA, Jan 28, 2022 – (JCN Newswire via SEAPRWire.com) – Biogen Inc. 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... » read more

polly written 1 year ago

Eisai’s Anti-amyloid Beta Protofibril Antibody Lecanemab Selected as the Background Therapy for the Tau Nexgen Study

TOKYO, Jan 19, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. 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). The study will assess the effect of Eisai’s... » read more

polly written 1 year ago

Eisai: New Phase 3 Data Show Positive Correlation Between ADUHELM Treatment Effect on Biomarkers and Reduction in Clinical Decline in Alzheimer’s Disease

TOKYO, Nov 12, 2021 – (JCN Newswire via SEAPRWire.com) – Biogen Inc. and Eisai Co., Ltd. (Tokyo, Japan) announced that data from approximately 7,000 plasma samples from more than 1,800 patients in the ADUHELM (aducanumab-avwa) Phase 3 clinical trials showed a statistically significant correlation between plasma p-tau reduction and less cognitive and functional decline in... » read more

polly written 1 year ago

Eisai Presents New Analysis of Lecanemab Clinical Efficacy Results from Phase 2b Study at Clinical Trials On Alzheimer’s Disease (CTAD) Conference

TOKYO and CAMBRIDGE, Mass., Nov 12, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today results of sensitivity analyses evaluating the consistency of lecanemab efficacy results across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early... » read more

polly written 1 year ago

Eisai: DIAN-TU Selects Lecanemab as Background Anti-Amyloid Therapy in Clinical Trial Evaluating Investigational Therapy Targeting Tau for Dominantly Inherited Alzheimer’s Disease

TOKYO, Nov 9, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has an agreement with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to amend the clinical... » read more

polly written 1 year ago

Eisai Presents New Data on the Relationship Between Clinical, Biomarker and Safety Outcomes from the Lecanemab Phase 2B Study

TOKYO, Nov 4, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. 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 initiated a rolling submission of a Biologics License Application... » read more

polly written 1 year ago

Biogen and Eisai Announce Design of ADUHELM ICARE AD-US Study, the First Real-World Observational Phase 4 Study in Alzheimer’s Disease at AAIC 2021

TOKYO, Jul 30, 2021 – (JCN Newswire via SEAPRWire.com) – Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo) today announced that Biogen led a late-breaking presentation on the design of the first real-world observational Phase 4 study in Alzheimer’s disease called ICARE AD-US, at the Alzheimer’s Association International Conference (AAIC), being held both virtually and... » read more

polly written 2 years ago

Biogen and Eisai Announce ADUHELMTM (aducanumab-avwa) Data Presentations at Alzheimer’s Association International Conference 2021

TOKYO, Jul 27, 2021 – (JCN Newswire via SEAPRWire.com) – Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen, as part of its Alzheimer’s disease (AD) research portfolio, will contribute four virtual posters that showcase data from its clinical trials with ADUHELM (aducanumab-avwa) injection 100 mg/mL solution at the Alzheimer’s Association... » read more

polly written 2 years ago

Eisai to Present Latest Data on Pipeline Assets in The Area of Alzheimer’s Disease and Dementia at AAIC 2021

TOKYO, Jul 21, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that the company will conduct a total of 11 presentations, including the latest data of the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (development code: BAN2401) for which the U.S. Food and Drug Administration has granted Breakthrough Therapy designation, at... » read more

polly written 2 years ago

Biogen and Eisai launch initiatives to help patients with Alzheimer’s disease access ADUHELM

Cambridge, MA, Jun 8, 2021 – (JCN Newswire via SEAPRWire.com) – Following U.S. Food and Drug Administration’s (FDA) accelerated approval of ADUHELMTM (aducanumab-avwa) 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 (Nasdaq: BIIB) and Eisai Inc., U.S. subsidiary... » read more

polly written 2 years ago

FDA grants accelerated approval for ADUHELM as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease

TOKYO, Jun 8, 2021 – (JCN Newswire via SEAPRWire.com) – Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for ADUHELM (aducanumab-avwa) as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid... » read more

polly written 2 years ago

Notice Regarding Biogen’s Disclosure About the Submission of Marketing Authorization Applications in Brazil, Canada, Australia, and Switzerland for Aducanumab for Alzheimer’s Disease

TOKYO, Apr 23, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that Biogen (Nasdaq: BIIB) has disclosed, in its Q1 2021 Earnings Press Release issued on April 22, its current submission status of the Marketing Authorization Applications (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease, in countries other than the... » read more

polly written 2 years ago