clinical

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

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

TOKYO, Mar 4, 2022 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. 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 (Abeta) protofibril antibody lecanemab (BAN2401). The lecanemab... » read more

Avance Clinical Announces New Office Opening in Sydney

SYDNEY, Mar 2, 2022 – (ACN Newswire via SEAPRWire.com) – Avance Clinical, the largest premium Australian Contract Research Organisation (CRO) for international biotechs, has opened new offices in Sydney to support its growing clinical team in the greater Sydney region. Avance Clinical’s CEO Yvonne Lungershausen said: “We continue to offer a hybrid working environment for... » read more

Novotech Recognized as Top 10 CRO in CenterWatch Site Relationship Benchmarking Report

SYDNEY, Feb 9, 2022 – (ACN Newswire via SEAPRWire.com) – Novotech, the leading Asia Pacific biotech specialist CRO, has been recognized as a top 10 CRO in the 2021 CenterWatch Global Site Relationship Benchmark Survey. Report available here. https://novotech-cro.com/news/novotech-recognized-top-10-cro-centerwatch-site-relationship-benchmarking-report CenterWatch, established in 1994, is a global benchmarking authority for the clinical trials sector. The benchmarking... » read more

SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE

HONG KONG, Feb 7, 2022 – (ACN Newswire via SEAPRWire.com) – SinoMab BioScience Limited (“SinoMab” or the “Company”, together with its subsidiaries, the “Group”, stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 21... » read more

Football: Clinical Barcelona down Atletico 4-2 win at Camp Nou

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

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

Avance Clinical在2022年生物技术展上宣布为美国扩张进行重大私募股权投资

ADELAIDE, AUS, Jan 19, 2022 – (亚太商讯 via SEAPRWire.com) – Avance Clinical 是澳大利亚最大的国际生物技术高级合同研究组织 (CRO)，已获得全球私...

Avance Clinical Announces Major PE Investment for US Expansion at Biotech Showcase 2022

ADELAIDE, AUS, Jan 18, 2022 – (ACN Newswire via SEAPRWire.com) – Avance Clinical, the largest premium Australian Contract Research Organisation (CRO) for international biotechs, has secured a significant investment from global private equity firm, The Riverside Company (Riverside), to support further regional and global expansion. The investment values the company in excess of $200m. Avance... » read more

Phase I Clinical Trial of AIM mRNA COVID-19 Vaccine (LVRNA009) Won the Praise of the Industry for High Safety and Well Tolerance

HANGZHOU, CHINA, Jan 12, 2022 – (ACN Newswire via SEAPRWire.com) – On January 8, AIM Vaccine held a meeting at Shulan (Hangzhou) Hospital to report on the analysis results of the phase I clinical trial data of its mRNA COVID-19 vaccine (LVRNA009). Safety data on the phase I clinical trial was released by Director Chen... » read more

B-cell lymphoma clinical trials now open on the TrialWire Platform

ADELAIDE, AUS, Jan 5, 2022 – (ACN Newswire via SEAPRWire.com) – TrialWire(TM) is pleased to announce new B-cell lymphoma clinical studies are now available on the TrialWire Platform. More than 6 million people have used TrialWire over the past few years to find clinical trials that are right for them at clinics and specialist centers... » read more

Autism clinical trials now open on the TrialWire Platform

ADELAIDE, AUS, Jan 5, 2022 – (ACN Newswire via SEAPRWire.com) – TrialWire(TM) is pleased to announce new Autism (ASD) clinical studies are now available on the TrialWire Platform. More than 6 million people have used TrialWire over the past few years to find clinical trials that are right for them at clinics and specialist centers... » read more

Investigational Alzheimer’s Disease Therapy Lecanemab Granted FDA Fast Track Designation

TOKYO, Dec 24, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and Biogen Inc. announced today that lecanemab, an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). FDA granted Breakthrough Therapy designation for lecanemab... » read more

SinoMab Announces the Completion of Enrollment in Phase III Clinical Trial in China for its Flagship Product, SM03

HONG KONG, Nov 30, 2021 – (ACN Newswire via SEAPRWire.com) – SinoMab BioScience Limited (“SinoMab”, or the “Company”, stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 30 November 2021, SM03 (Suciraslimab) Phase III... » read more

Apollomics Inc. Doses First Patient in Phase 3 Clinical Trial with APL-106 (Uproleselan Injection) in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia

Foster City, CA, Shanghai and Hangzhou, China, Nov 22, 2021 – (ACN Newswire via SEAPRWire.com) – Apollomics Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, today announced that the first patient has been successfully dosed in a Phase 3 clinical trial of APL-106 (uproleselan injection) for... » read more

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

Eisai: Introduction of Plasma-based Biomarker Screening to Facilitate Identification of Subjects for Phase 3 Ahead 3-45 Trial Presented 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 a presentation about exploring the use of plasma-based biomarkers in the Phase 3 AHEAD 3-45 study of lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody. AHEAD 3-45 is the first preclinical Alzheimer’s disease (AD)... » read more

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

Avance Clinical Client News: XWPharma Initiates First-in-Human Studies of XW10508, in Development for Fast-acting Relief of Treatment-Resistant Depression and Chronic Pain

ADELAIDE, AUS, Oct 19, 2021 – (ACN Newswire) – Avance Clinical, the largest premium Australian CRO for international biotechs, is pleased to share the news that its client XWPharma Ltd. has announced dosing of subjects in its first-in-human study evaluating XW10508, the Company’s novel, patented, glutamatergic NMDA antagonist and AMPA activator in development as an oral, once-daily therapy for... » read more