Investigators at Stanford University Medical Center have treated the first patient in a pivotal phase III study of Abeona Therapeutics Inc.'s EB-101, an autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The trial, delayed by an FDA clinical hold placed in September 2019, has now resumed, with the majority of its 15 expected participants pre-screened.
Jerusalem-based Brainsway Ltd. had good news to report with the presentation of positive data from a multicenter study evaluating its deep transcranial magnetic stimulation (dTMS) system as an aid in smoking cessation.
Beta-O2 Technologies Ltd. plans to enroll its first patients in clinical trials for its second-generation bio-artificial pancreas, ßAir, in the coming months. The small, implantable titanium device has separate components that hold pancreatic cells and a rechargeable oxygen tank. Beta-O2 is based in Rosh-Haayin, Israel.
Bridgebio Pharma Inc. subsidiary QED Therapeutics Inc., seeded in 2018 with $65 million and a license to Novartis AG's infigratinib, said the first patients have been dosed with the drug in two separate cancer trials.
Anti-drug antibodies noted in the phase Ib portion of the PREVAIL study in lupus drew queries for Oldwick, N.J.-based Provention Bio Inc. during a conference call related to earnings, but analysts seemed more interested in the company’s later-stage push in type 1 diabetes (T1D).
In a second phase III trial for treating progressive forms of multiple sclerosis (MS), designed to confirm the successful first trial, Medday Pharmaceuticals SA’s investigational MD-1003 failed to hit its primary and secondary endpoints.
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. plans to evaluate its allogeneic mesenchymal stem cell (MSC) candidate, remestemcel-L, in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the U.S., Australia, China and Europe.
BEIJING – Beijing-based Sihuan Pharmaceutical Holdings Group Ltd. said it has initiated clinical trials of broad-spectrum antiviral favipiravir to treat COVID-19. China now has six clinical trials investigating the drug, originally developed for influenza and also tested against Ebola virus disease.