While the staff at the U.S. Department of Health and Human Services (HHS) is currently all hands-on-deck in responding to the COVID-19 outbreak, some of the agencies in the department may have to divert resources to get sponsors of drug and device clinical trials to fill in nearly a decade-long data gap on Clinicaltrials.gov. That’s if a judge’s decision handed down this week stands.
PERTH, Australia – Sydney-based Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer (NSCLC) and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s anti-PD-1 therapy, Keytruda (pembrolizumab).
DUBLIN – Adrenomed AG disclosed Feb. 21 that its first-in-class antibody, adrecizumab, hit the primary safety and tolerability endpoint of a phase II trial in septic shock.
Updated results from IMV Inc.’s ongoing phase II trial of DPX-Survivac to treat advanced recurrent ovarian cancer show the company’s lead candidate was active and well-tolerated in patients.
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).
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.
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.
RSS
