NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).
NGM Biopharmaceuticals Inc. wowed investors with positive preliminary top-line results from the 24-week double-blind, randomized, placebo-controlled fourth cohort of an adaptive phase II study testing aldafermin in nonalcoholic steatohepatitis (NASH).
Trisalus Life Sciences Inc., of Westminster, Colo., reported the start of a clinical trial assessing a treatment that combines its intravascular, tumor-directed proprietary Pressure-Enabled Drug Delivery (PEDD) approach with standard-of-care systemic chemotherapy.
Teva Pharmaceutical Industries Ltd.’s Austedo (deutetrabenazine) lived up to the lack of expectations in pediatric Tourette syndrome (TS), missing identical primary endpoints in a pair of late-stage trials.
PERTH, Australia – Medicinal cannabis company Zelira Therapeutics Ltd. reported that its ZLT-101 therapy met the primary endpoint of a statistically significant improvement in insomnia in a phase Ib/IIa study in patients diagnosed with chronic insomnia.
The results from a study comparing San Diego-based Bionano Genomics Inc.’s Saphyr to traditional cytogenetic methods for the clinical analysis of leukemia genomes revealed that the system was 100% concordant with the standard of care for the detection of somatic chromosomal abnormalities.
It’s been a rapid year of change for Coimmune Inc., which was incorporated only 12 months ago and now has FDA approval of an IND clearing the way for a phase IIb trial using CMN-001 to treat advanced metastatic renal cell carcinoma (mRCC).
BEIJING – Multiple China-based clinical trials have been put on hold as the country concentrates on its fight against COVID-19. To curb the spread of the novel coronavirus that has infected over 72,000 people and killed nearly 2,000, China has imposed travel and transport restrictions, making trips difficult or even impossible for patients and physicians.
Shares of Bellerophon Therapeutics Inc. (NASDAQ:BLPH), rescued from potential delisting by a recent reverse stock split, shot 168.4% higher to $9.20 on Feb. 18 as new top-line data from a small phase II study showed its inhaled nitric oxide delivery system, Inopulse, delivered significant improvements in blood flow for people with pulmonary hypertension (PH) associated with pulmonary fibrosis (PF).
Privately held Zhittya Genesis Medicine Inc. received approval from Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) to begin a phase I trial at the Zambrano Hospital in Monterrey for patients with Parkinson’s disease.
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