PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software as a medical device (SaMD).
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.
PERTH, Australia – With a capital raise of $AU4.58 million (US$3.07 million) under its belt, Zelira Therapeutics Ltd. will be better positioned to launch multiple medicinal cannabis products that are currently in late-stage clinical trials.
PERTH, Australia – Brisbane, Australia-based Field Orthopaedics was formed when a group of orthopedic surgeons were exasperated by ongoing shortcomings in surgical practice and decided to do something about it.
PERTH, Australia – As of Feb. 12, Australia’s Department of Health confirmed 15 cases of novel coronavirus in Australia (five in Queensland, four in New South Wales, four in Victoria and two in South Australia). Of the confirmed 15 cases, five people have recovered and the others are in stable condition.
PERTH, Australia – Mesoblast Ltd. has filed the final module of its rolling BLA submission for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, after it showed strong survival rates in children with acute steroid-refractory graft-vs.-host disease (aGVHD).
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. has filed the final module of its rolling BLA submission for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, after it showed strong survival rates in children with acute steroid-refractory graft-vs.-host disease (aGVHD).
PERTH, Australia – With new funding in hand from Yamaha Motor Ventures & Laboratory Silicon Valley Inc., Loop+ founders and sisters Kath Hamilton and Clare Conroy and are on their way to commercializing a pressure and movement tracking device they developed for wheelchair-bound patients.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year.
