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Tag: disease

HighTide Therapeutics Announces First Patient Dosed in Phase 2b Clinical Study Evaluating HTD1801 in NASH (the CENTRICITY study)

Irene

ROCKVILLE, MD and SHENZHEN, CHINA, Jan 11, 2023 – (ACN Newswire via SEAPRWire.com) – HighTide Therapeutics Inc. (“HighTide”), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the dosing of the first patient in a Phase 2b clinical study evaluating HTD1801 for the treatment of nonalcoholic steatohepatitis […]

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

Putri

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 […]

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

Putri

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 […]

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

Putri

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 […]

Eisai: MHLW Grants Orphan Drug Designation in Japan to Mecobalamin Ultrahigh-Dose Formulation with Prospective Indication for Delaying the Progression of Disease and Functional Impairment of ALS

Putri

TOKYO, May 27, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that it has received orphan drug designation for ultrahigh-dose mecobalamin, with a prospective indication for delaying the progression of disease and functional impairment of amyotrophic lateral sclerosis (ALS), by the Ministry of Health, Labour and Welfare (MHLW). ALS is an […]

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

Putri

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 […]

Shionogi and NEC Enter into Strategic Research Collaboration for Novel Hepatitis B Therapeutic Vaccine

Putri

OSAKA, Japan and TOKYO, Japan, Apr 18, 2022 – (JCN Newswire via SEAPRWire.com) – Shionogi & Co., Ltd. and NEC Corporation, today announced the execution of a strategic research collaboration agreement for the development of a novel hepatitis B therapeutic vaccine. NEC OncoImmunity, an NEC subsidiary that specializes in artificial intelligence-driven biotechnology, is also participating […]

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

Putri

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 […]

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

Putri

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 […]

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

Putri

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 […]

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

Putri

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 […]

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

Putri

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 […]

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

Putri

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 […]

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

Putri

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 […]

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

Putri

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 […]

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

Putri

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 […]

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

Putri

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 […]

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

Putri

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 […]

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

Putri

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 […]

Eisai: 18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimer’s Disease

Putri

TOKYO, Apr 20, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer’s Disease with Lecanemab, an Anti-Abeta Protofibril Antibody, in the peer-reviewed journal Alzheimer’s Research and Therapy. The manuscript describes results […]

Eisai: Animation Featuring Lymphatic Filariasis Elimination Activities Receives Animation Award at International Society for Neglected Tropical Diseases Festival 2021

Putri

TOKYO, Apr 12, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced that its animation “Leave No One Behind-Disease of Neglected People” which features activities for the elimination of lymphatic filariasis (LF) has received the Animation Award at the International Society for Neglected Tropical Diseases (ISNTD) Festival 2021. ISNTD Festival is an annual […]

Eisai: Anti-MTBR (Microtubule Binding Region) Tau Antibody E2814 is Selected on Clinical Study for Dominantly Inherited Alzheimer’s Disease by Dian-Tu

Putri

TOKYO, Mar 16, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that anti-microtubule binding region (MTBR) tau antibody E2814, which was created from collaboration research between Eisai and University College London, has been selected by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) led by Washington University School of Medicine in […]

Eisai to Present Latest Data on Pipeline Assets in the Area of Alzheimer’s Disease and Dementia at the 15th International Conference on Alzheimer’s and Parkinson’s Disease

Putri

TOKYO, Mar 5, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. announced today that the latest data from its Alzheimer’s disease (AD) and dementia pipeline, including the investigational anti-amyloid beta (Aß) protofibril antibody lecanemab (Development Code: BAN2401), will be presented at the 15th International Conference on Alzheimer’s and Parkinson’s Disease (AD/PD2021) to be […]