PERTH, Australia – Researchers at the QIMR Berghofer Medical Research Institute in Queensland have developed a way of testing whether COVID-19 patients’ immune systems are gearing up to fight the virus that causes the disease.
PERTH, Australia – Med-tech company Control Bionics began trading on the Australian Securities Exchange (ASX:CBL) Dec. 7 in an IPO that saw the company raise AU$15 million (US$11.25 million). Melbourne-headquartered Control Bionics develops assistive technologies (AT) that allow people with severe disabilities to communicate and control electronic devices using electromyography (EMG).
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is requiring manufacturers of permanently implantable devices to provide patient implant cards and consumer device leaflets with their devices, beginning Dec. 1. New implantable devices will need to comply by Dec. 1, 2020, and existing implantable devices will have until Dec. 1, 2021, to comply.
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) has unveiled its final regulatory requirements for personalized medical devices, including 3D-printed devices, that go into effect on Feb. 25, 2021. Under the previous framework, custom-made medical devices were exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG).
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. is acquiring Scintec Diagnostics GmbH subsidiary Therapharm GmbH in a deal worth AU$33 million (US$24.24 million) plus royalties.
Zug, Switzerland-based Therapharm has developed a portfolio of radiolabeled diagnostic and therapeutic products, and the deal brings Telix a new targeting asset in hematology, Telix CEO Chris Behrenbruch told analysts during a Dec. 1 conference call.
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
PERTH, Australia – Sydney-based Imugene Ltd.’s stock shot up 15% on news that an interim analysis of phase II data in its B-cell peptide vaccine, HER-Vaxx, in advanced gastric cancer showed positive survival data, and the data monitoring committee said it could lower the number of patients required for study completion.