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Relaxed Regulations for Clinical Trials of Low-risk Medical Devices, Including AI, in South Korea

Relaxed Regulations for Clinical Trials of Low-risk Medical Devices, Including AI, in South Korea

SEOUL, Jan. 10 (Korea Bizwire) – The South Korean Ministry of Food and Drug Safety (MFDS) has announced that clinical trials for low-risk medical devices, including medical artificial intelligence (AI), can now be conducted without the need for clinical plan approval from the MFDS. This change will also allow trials to be conducted outside of designated [...]

Fortrea Announces AI-Driven Partnership with Medidata to Increase Diversity in Clinical Trials

Fortrea Announces AI-Driven Partnership with Medidata to Increase Diversity in Clinical Trials

Collaboration leverages Medidata AI to improve access and participation of diverse population groups in clinical studies DURHAM, N.C., Nov. 20, 2023 (Korea Bizwire) – Fortrea (Nasdaq: FTRE), a leading global contract research organization (CRO), today announced a partnership with Medidata, a Dassault Systèmes company and leading provider of clinical trial solutions to the life sciences industry, to use Medidata [...]

Clinical Trials in China: Unlocking the Potential of Advanced Therapies Presented by Novotech and Endpoints News

Clinical Trials in China: Unlocking the Potential of Advanced Therapies Presented by Novotech and Endpoints News

BOSTON, Sept. 11, 2023 (Korea Bizwire) – Novotech, the leading Asia Pacific centred biotech CRO with global execution capabilities, announced today an expert panel webinar on Clinical Trials in China: Unlocking the Potential of Advanced Therapies. Novotech is collaborating with Endpoints News to jointly host this webinar. The webinar will examine how China’s focus on cutting-edge innovations and [...]

Industry Survey Identifies Successful Biotech Clinical Trial Strategies

Industry Survey Identifies Successful Biotech Clinical Trial Strategies

SYDNEY, Australia, May 8 (Korea Bizwire) — Novotech, the leading Asia Pacific centred biotech CRO conducted a survey of global biotech professionals, in partnership with Citeline, on their current and future clinical pipeline prospects, the main challenges of clinical trials, and perspective shifts regarding study locations. A key finding from the report is that cost [...]

Novadiscovery Announces Nature Communications Paper on Modeling the Disruption to Respiratory Clinical Trials Due to Mitigation Measures Against COVID-19

Novadiscovery Announces Nature Communications Paper on Modeling the Disruption to Respiratory Clinical Trials Due to Mitigation Measures Against COVID-19

Lyon, France, 13 April 13 (Korea Bizwire) – Novadiscovery (NOVA), a leading health tech company using in silico clinical trials to predict drug efficacy and optimize clinical trial development, today announces the publication of a novel model of respiratory tract infections (RTI) in Nature Communications to address the uncertainties resulting from non-pharmaceutical interventions (NPIs) against COVID-19 on clinical trials. The paper was [...]

Koreans Support Domestic Vaccine Development, but Don’t Want to Participate in Clinical Trials: Survey

Koreans Support Domestic Vaccine Development, but Don’t Want to Participate in Clinical Trials: Survey

SEOUL, June 22 (Korea Bizwire) — A majority of South Koreans share the view that the country should develop a domestic COVID-19 vaccine, but their attitude towards participating in clinical trials remains passive. The Ministry of Health and Welfare and the Korea National Enterprise for Clinical Trials jointly conducted a survey of 1,600 men and [...]

Peptomyc’s Omomyc-based Therapy, OMO-103, Has Obtained Approval for First-in-human Phase I/II Trial to Assess the Efficacy and Safety of a Novel Myc Inhibitor

Peptomyc’s Omomyc-based Therapy, OMO-103, Has Obtained Approval for First-in-human Phase I/II Trial to Assess the Efficacy and Safety of a Novel Myc Inhibitor

BARCELONA, Spain, March 18 (Korea Bizwire) — Co-founded back in 2014 by VHIO’s Laura Soucek, CEO of the enterprise, and Marie-Eve Beaulieu, Chief Scientific Officer (CSO) of the company, VHIO-born spin-off Peptomyc S.L. has just announced that it has received approval from the Spanish Agency of Medicines and Medical Devices for conducting clinical trials in Spain [...]

Drug Ministry Approves Clinical Trials of Coronavirus Vaccine, Treatment

Drug Ministry Approves Clinical Trials of Coronavirus Vaccine, Treatment

SEOUL, Nov. 24 (Korea Bizwire) – South Korea’s drug safety agency has approved clinical trials of vaccine and treatment candidates currently under development by two local drug manufacturers, industry officials said Tuesday. The Ministry of Food and Drug Safety on Monday gave the green light to conduct a phase one clinical trial of a vaccine [...]

S. Korean Bio Firms in Race for COVID-19 Treatment, Vaccine Development

S. Korean Bio Firms in Race for COVID-19 Treatment, Vaccine Development

SEOUL, Oct. 3 (Korea Bizwire) — South Korean pharmaceutical companies have joined the global race to develop vaccines and treatments for the novel coronavirus, and several of them have received approval for clinical trials from the country’s drug safety agency. Among the front-runners is Celltrion Inc.’s antiviral antibody treatment candidate called CT-P59 that is currently [...]

Informa Pharma Intelligence Launches New Pulse Report: Clinical Trials & the COVID-19 Vaccine

Informa Pharma Intelligence Launches New Pulse Report: Clinical Trials & the COVID-19 Vaccine

LONDON, Oct. 1 (Korea Bizwire) – Informa Pharma Intelligence, the global business intelligence provider for the biopharma industry, today released its “Pulse Report: Clinical Trials & the COVID-19 Vaccine” study which uncovered American sentiment and confidence around COVID-19 vaccine clinical trials. According to the data, more than 1 in 3 (35%) Americans don’t trust how quickly the COVID-19 [...]