EU Regulatory Roundup: UK Reassures Industry it Will Adopt EU Clinical Trial Regulation

EU Regulatory Roundup: UK Reassures Industry it Will Adopt EU Clinical Trial Regulation

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   UK Reassures Industry it Will Adopt EU Clinical Trial Regulation Despite Brexit   The United Kingdom has committed to adopting the European Union Clinical Trial Regulation despite Brexit. A government representative in the House of Lords made the promise […]

Sutro Initiates First Clinical Trial of CD74-Targeting ADC for Lymphoma & Multiple Myeloma Treatment; The First of a …

Sutro Initiates First Clinical Trial of CD74-Targeting ADC for Lymphoma & Multiple Myeloma Treatment; The First of a …

Sutro expects to enroll up to 220 patients in the open-label, multicenter, dose escalation and dose expansion study across approximately 50 sites in the United States and Europe. The primary outcome measures are safety and tolerability of STRO-001 in dose escalation and preliminary anti-tumor activity in dose expansion. “Based on preclinical research findings, we are […]

MediciNova Announces Additional Data from Completed Clinical Trial of MN-166 (ibudilast) in ALS Presented at the …

MediciNova Announces Additional Data from Completed Clinical Trial of MN-166 (ibudilast) in ALS Presented at the …

LA JOLLA, Calif., April 26, 2018 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), announced that principal investigator Dr. Benjamin Rix Brooks, Director, Carolinas HealthCare System’s Neuromuscular/ALS-MDA Center at Carolinas HealthCare System Neurosciences Institute, will present additional clinical […]

New clinical trial shows safety and efficacy of second generation drug-eluting stents

New clinical trial shows safety and efficacy of second generation drug-eluting stents

April 26, 2018 Results of the PERSPECTIVE trial were presented today as late-breaking clinical science at the Society for Cardiovascular Angiography and Interventions (SCAI) 2018 Scientific Sessions. The PERSPECTIVE study is a prospective, single-center rigorously performed clinical trial and reports on one-year outcomes of patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) treated […]

FDA Approves First Gene Therapy Clinical Trial For Rare Disease

FDA Approves First Gene Therapy Clinical Trial For Rare Disease

The U.S. Food and Drug Administration has approved the first gene therapy clinical trial for a rare disease treated in Hartford by a physician brought from Florida by parents of his young patients. Patient clinical trials for glycogen storage disease, which affects the liver’s storage and release of sugar, are expected to begin this year […]

Kadimastem Announces the Enrollment of the First Patient for Its Clinical Trial in ALS Patients

Kadimastem Announces the Enrollment of the First Patient for Its Clinical Trial in ALS Patients

The objective of the trial is to evaluate the safety and efficacy of AstroRx® in patients. Interim results of the trial are expected within the coming year. Professor Michel Revel, the company’s Chief Scientist, said: “Kadimastem’s commencement of the clinical trial in ALS, according to the clinical protocol, is a significant milestone in the company’s […]

DiscGenics Announces First Patient Treated in US Clinical Trial of IDCT for Degenerative Disc Disease

DiscGenics Announces First Patient Treated in US Clinical Trial of IDCT for Degenerative Disc Disease

IDCT is an allogeneic (donor-derived), non-invasive cell therapy comprised of proprietary Discogenic Cells and a viscous scaffold carrier. This prospective, randomized, double-blinded, vehicle- and placebo-controlled study is designed to evaluate the safety and preliminary efficacy of IDCT at varying dosage levels in subjects with single-level, symptomatic lumbar DDD, a major cause of chronic low back […]

New clinical trial shows second generation drug-eluting stents are safe and effective

New clinical trial shows second generation drug-eluting stents are safe and effective

SAN DIEGO, April 26, 2018 – Results of the PERSPECTIVE trial were presented today as late-breaking clinical science at the Society for Cardiovascular Angiography and Interventions (SCAI) 2018 Scientific Sessions. The PERSPECTIVE study is a prospective, single-center rigorously performed clinical trial and reports on one-year outcomes of patients undergoing chronic total occlusion (CTO) percutaneous coronary […]