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S. Korea Approves Phase 1 Trials for Celltrion’s COVID-19 Treatment Substance

S. Korea Approves Phase 1 Trials for Celltrion’s COVID-19 Treatment Substance

SEOUL, July 17 (Korea Bizwire) — South Korea approved phase one clinical trials for Celltrion Inc.’s coronavirus antibody treatment substance, the country’s drug safety agency said Friday. The move to test CT-P59 marks the first time that a locally made genetic recombination antibody treatment material has been given the green light to be used on [...]

Junshi Biosciences Announces Completion of Enrollment in Phase I Trial of SARS-CoV-2 Neutralizing Antibody JS016 in China

Junshi Biosciences Announces Completion of Enrollment in Phase I Trial of SARS-CoV-2 Neutralizing Antibody JS016 in China

SHANGHAI, China, July 12 (Korea Bizwire) — Junshi Biosciences (HKEX: 1877), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today the completion of study subjects enrollment in Phase I trial of SARS-CoV-2 neutralizing monoclonal antibody injection (Product Code: JS016), developed jointly with Institute of Microbiology, Chinese Academy [...]

S. Korean Company to Start Clinical Trial for Potential Coronavirus Treatment in U.S.

S. Korean Company to Start Clinical Trial for Potential Coronavirus Treatment in U.S.

SEOUL, June 11 (Korea Bizwire) — South Korean biopharmaceutical maker Genexine Inc. said Thursday it has won approval to conduct a clinical trial for its potential coronavirus treatment in the United States. The U.S. Food and Drug Administration (FDA) gave the green light for the phase 1 clinical trial of anti-cancer drug candidate GX-I7 for [...]

Philips Launches HealthSuite Clinical Trial Accelerator to Help Life Science Organizations Run More Flexible, Patient-centric Clinical Trials

Philips Launches HealthSuite Clinical Trial Accelerator to Help Life Science Organizations Run More Flexible, Patient-centric Clinical Trials

Amsterdam, the Netherlands, May 19 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced Clinical Trial Accelerator on Philips HealthSuite. This new tailored set of capabilities allows life science organizations to integrate, analyze and store clinical and patient-reported data from multiple sources, providing actionable insights for better, faster decision-making. [...]

Algernon Receives Clearance from Health Canada for Ifenprodil COVID-19 Phase 2b/3 Multinational Clinical Trial

Algernon Receives Clearance from Health Canada for Ifenprodil COVID-19 Phase 2b/3 Multinational Clinical Trial

VANCOUVER, British Columbia, April 29 (Korea Bizwire) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to announce that it has received a No Objection Letter from Health Canada to proceed with a NP-120 (Ifenprodil) COVID-19 Phase 2b/3 multinational clinical trial. The same [...]

CoImmune, Inc. Announces FDA Approval of its IND Application to Conduct a Phase 2b Clinical Trial with CMN-001 in Advanced RCC Patients

CoImmune, Inc. Announces FDA Approval of its IND Application to Conduct a Phase 2b Clinical Trial with CMN-001 in Advanced RCC Patients

DURHAM, N.C., Feb. 19 (Korea Bizwire) — CoImmune, Inc. announced today that the FDA approved its investigational new drug application (IND) and that it is cleared to move forward with a Phase 2b clinical trial in advanced metastatic renal cell carcinoma (mRCC). CMN-001, formerly known as AGS-003, is a dendritic cell-based immunotherapy custom matched to [...]

Informa Pharma Intelligence Launches New Product Citeline Engage

Informa Pharma Intelligence Launches New Product Citeline Engage

LONDON, Oct. 10 (Korea Bizwire) – Informa Pharma Intelligence today announces Citeline Engage, a new solution allowing contact research organizations (CROs) and sponsors to optimize site selection and increase trial efficiencies to accelerate clinical trial timelines and enable a faster path to market for drugs. Citeline Engage is a first-to-market solution designed specifically to help optimize protocol [...]

Safety and Efficacy of Philips’ Stellarex .035 Low-dose Drug-coated Balloon Demonstrated in Clinical Trials at Three Years

Safety and Efficacy of Philips’ Stellarex .035 Low-dose Drug-coated Balloon Demonstrated in Clinical Trials at Three Years

Amsterdam, the Netherlands and New Orleans, U.S., May 29 (Korea Bizwire) – Royal Philips (NYSE: PHG; AEX: PHIA), a global leader in health technology, today announced the three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE European randomized clinical trial (EU RCT). These two trials are part of a series of five trials evaluating the [...]

Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Major Depressive Disorder

Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Major Depressive Disorder

NEW YORK, Jan. 7 (Korea Bizwire) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the prespecified primary endpoint and significantly improved symptoms of depression in the [...]