LONDON – Three years after the implementation of new U.S. legislation requiring clinical trials to report results within 12 months of completion, more than half are not published on time and compliance is not improving.
A new study of 30 patients has demonstrated that embolization coils adequately seal the left atrial appendage after implant of LAA closure devices, but the author of an accompanying editorial expressed concerns regarding the absence of understanding of both the causes and implications of these leaks.
China-based Innovent Biologics Inc. will need to get on two new tasks this year: Preparing for the first clinical trial for an anti-TIGIT antibody in China and investigating the combination therapy of its Tyvyt (sintilimab) and Sirnaomics Inc.’s STP-705.
Abbott Park, Ill.-based Abbott Laboratories has gained the U.S. FDA’s nod for a clinical trial that will compare the effectiveness of Mitraclip to open-heart mitral valve surgical repair in people with primary mitral regurgitation (MR) who are eligible for open-heart surgery. The prospective, randomized REPAIR MR clinical trial is expected to enroll 500 patients.
While companies have seen plenty of success treating blood cancers with T-cell therapies, solid tumors have largely remained the holy grail for T cells. But Adaptimmune Therapeutics plc has early data from its Specific Peptide Enhanced Affinity Receptor T-cell platform suggesting it may be on the right path for a platform with a wide breadth.
With a label broadened by the FDA in December and two aspiring competitors apparently picked off via late-stage trial blowups, Amarin Corp. plc finds itself in strong position with fish oil therapy Vascepa (icosapent ethyl) – at least pending the outcome of court proceedings that involve challengers to patents for the cardiovascular (CV) drug.
LONDON – Verona Pharma plc reported positive phase IIb results for the nebulized formulation of its dual phosphodiesterase (PDE) 3 and 4 inhibitor, ensifentrine (RPL-554), as an add-on to standard bronchodilation therapy in chronic obstructive pulmonary disorder (COPD).
LONDON – Kandy Therapeutics Ltd. has announced positive results for its nonhormonal treatment for menopause symptoms, showing a reduction in the number of hot flashes and night sweats, and a positive effect on secondary endpoints relating to mood and quality of life.
BEIJING – China-based Innovent Biologics Inc. will need to get on two new tasks this year: Preparing for the first clinical trial for an anti-TIGIT antibody in China and investigating the combination therapy of its PD-1 antibody, Tyvyt (sintilimab), and Sirnaomics Inc.’s RNAi drug candidate, STP-705.
The prospects for Ultragenyx Pharmaceutical Inc.'s adeno-associated virus (AAV) gene therapy, DTX-301, in patients with ornithine transcarbamylase (OTC) deficiency weren't looking too great after treatment of the first two cohorts in a phase I/II study.