Solid Biosciences Inc.'s chief technology officer, Joel Schneider, said the company is "not going to leave any stone unturned" as investigators begin to explore the severe adverse event (SAE) that led to the FDA's clinical hold on the phase I/II study with SGT-001 in Duchenne muscular dystrophy (DMD).
A little more than two months after completing enrollment, an interim analysis shows Kadmon Holdings Inc.'s pivotal trial of ROCKstar (KD-025-213) testing KD-025 in patients with chronic graft-vs.-host disease (cGVHD) met its primary endpoint of overall response rate. Read More
BOSTON – In a late-breaking oral presentation on the last day of The Liver Meeting 2019, Durect Corp. reported results from its phase IIa trial of DUR-928 for the treatment of alcoholic hepatitis. All 19 patients enrolled in the study survived for 28 days after treatment with DUR-928 , and all but two responded to the drug as measured by Lille scores, which is used for predicting risk of death. Read More
HAMBURG, Germany – Like any other sector, biotechnology has to engage with the wider political and economic environment it inhabits, as well as deal with the issues that are specific to it. A BIO-Europe panel discussion on transformative deals in 2019 concluded with a slightly nervous look ahead to what is increasingly looking like an uncertain macroeconomic situation. Read More
SHANGHAI – Innovation-driven biotech companies are sprouting up in China and they now aim to gain a bigger global presence through conducting clinical trials not just in their home country but also abroad. Read More
The fish were biting Tuesday at Amarin Corp., as the FDA released its briefing documents for Thursday's advisory committee review of a first-of-its-kind indication for the company's fish oil-based Vascepa. Read More
Drug addiction has often proved resistant to the best efforts for treatment. New York-based startup Medicasafe Inc. hopes to provide another tool in the arsenal to boost opioid use disorder (OUD) treatment. Rather than send a recovering addict home every couple of weeks with an unmonitored and uncontrolled supply of buprenorphine and naloxone, it has developed a drug-device combination product that digitally enables and tracks patient retrieval of those drugs. Read More
Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
