PERTH, Australia – Aussie regenerative medicine company Regeneus Ltd. has out-licensed its lead mesenchymal stem cell (MSC) and secretome therapy, Progenza, to Japan’s Kyocera Corp. for osteoarthritis of the knee for the Japan market.
PERTH, Australia – Australian regenerative medicine company Mesoblast Ltd. saw its stock tumble more than 30% following the release of briefing documents from the FDA ahead of an Aug. 13 advisory committee meeting to review the company’s BLA for Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease (SR-aGVHD) in children.
PERTH, Australia – As the state of Victoria in Australia records its deadliest day since the COVID-19 pandemic began, reporting 17 deaths and 394 new cases, Atomo Diagnostics Ltd.’s new COVID-19 antibody test could ease pressure on health care systems.
PERTH, Australia – A review by Australia’s Therapeutic Goods Administration (TGA) revealed that medical device recall databases may significantly under-represent software errors, causing harm to patients. These under-reported events are due to patients being unaware how to report problems, inadequate information being reported, effects of software errors being too subtle or difficult to detect, or root cause analyses that may not identify software as the source of error when it causes other components to fail.
PERTH, Australia – Startup Inventia Life Science Pty. Ltd. has received two major investments from the Australian government to accelerate the development of a robotic device that prints a patient’s own skin cells directly onto a burn or wound. Named Ligō from the Latin “to bind,” the device could revolutionize the way surgeons approach wound repair.
PERTH, Australia – Melbourne-based Dimerix Ltd.’s stock shot up nearly 20% on the news that its lead compound, DMX-200, met primary and secondary endpoints in a phase IIa trial in patients with rare kidney disease focal segmental glomerulosclerosis (FSGS), according to top-line results.
PERTH, Australia – The U.S. FDA gave the thumbs up to Australia’s Micro-X Ltd. for its Rover mobile X-ray system. The 510(k) application was cleared in just five weeks. The concept for the Rover was originally developed under a contract with the Australian Department of Defense to prove that Micro-X’s technology could fulfill an unmet need for a full performance, digital medical X-ray imager that was light enough to be used in deployed medical facilities.
PERTH, Australia – The University of Queensland’s Centre for Superbug Solutions has discovered a new class of antibiotics that has garnered an award from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).
PERTH, Australia – The University of Queensland’s Centre for Superbug Solutions has discovered a new class of antibiotics that has garnered an award from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).
PERTH, Australia – Melbourne-based Neuren Pharmaceuticals Ltd. will be able to progress NNZ-2591 to the clinic for three orphan indications after raising AU$20 million (US$13.75 million) in a placement to institutional and sophisticated investors in Australia, New Zealand, Hong Kong and the U.K.
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