The U.S. FDA granted Gtx Medical BV a breakthrough device designation for its implantable Go-2 Targeted Epidural Spinal Stimulation (TESS) system. The device enabled patients who had sustained traumatic spinal cord injuries to regain voluntary control over previously paralyzed muscles and walk again four or more years after paralysis, according to a study previously published in Nature.
HONG KONG – Astellas Pharma Inc. reported positive results from phase III of its DOLOMITES study comparing the efficacy and safety of roxadustat to that of darbepoetin alfa in treating anemia in nondialysis-dependent, stage 3 to 5 chronic kidney disease (CKD) patients.
PERTH, Australia – Melbourne, Australia-based Opthea Ltd. announced positive top-line results of its phase IIa trial evaluating safety and efficacy of OPT-302 administered with Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) in treatment-refractory patients with persistent diabetic macula edema (DME).
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Biondvax, Catalyst, Dermata, Devonian, Impel, Merck, Opthea, Orpheris, Pfizer, Pulmatrix, Tychan.
PERTH, Australia – Melbourne, Australia-based Dimerix Ltd. saw its shares gain 66% on the news that its lead candidate, DMX-200, has been chosen to enter the global REMAP-CAP platform trial as a potential treatment for COVID-19-related acute respiratory distress syndrome (ARDS).
A long-term clinical trial comparing minimally invasive cryoablation to surgery to treat early stage kidney cancer patients has found that the former offers comparable rates of survival and fewer complications. Johns Hopkins researchers published the 10-year survival data for 134 patients in the June 9, 2020, issue of Radiology.
Researchers at New York-based Feinstein Institutes for Medical Research, the research arm of Northwell Health, showed that anodal block can be used for directional vagus nerve stimulation (VNS) in a new paper in Scientific Reports.
Soleno Therapeutics Inc.’s phase III DESTINY PWS (C601) trial evaluating once-daily diazoxide choline controlled-release tablets for treating patients with Prader-Willi syndrome (PWS) missed its primary endpoint of change from baseline in hyperphagia, or insatiable hunger, which is the disease’s predominant syndrome.
DUBLIN – Alnylam Pharmaceuticals Inc. is on track to secure its third FDA approval in successive years, as its siRNA drug, lumasiran, hit all its marks in a phase III trial in patients with primary hyperoxaluria type 1 (PH1). The drug is already undergoing regulatory review and has a Dec. 3 PDUFA action date. It is undergoing accelerated assessment in Europe as well.
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