PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is pushing back implementation dates for numerous medical device reforms due to delays caused by the COVID-19 pandemic.
PERTH, Australia – Australia’s largest life science investment fund is pressing the government for an urgent COVID-19 response package to support the country’s AU$170 billion (US$117 billion) life sciences sector that is struggling to survive in a post-COVID-19 ecosystem.
PERTH, Australia – Sydney-based Speedx Pty. Ltd. has signed a global distribution deal with Roche Holding AG, through which the latter will sell Speedx’s Resistanceplus MG and Resistanceplus GC molecular tests for detecting antimicrobial resistance to Mycoplasma genitalium (Mgen) and gonorrhea, respectively.
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).
PERTH, Australia – On the heels of an AU$5 million ($US3.47 million) capital raise, digital health company Respiri Ltd. is preparing to launch its digital wheezo asthma measurement device in Australia as it transforms itself from a device manufacturer to an eHealth software as a service company (SaaS). Melbourne-based Respiri received its first batch of 500 wheezo devices in March, and the company plans to deploy them in Australia this quarter.
PERTH, Australia – The majority of stakeholders support the Therapeutic Goods Administration’s (TGA) proposal to restructure Australia’s device essential principles to align with the requirements under the new EU Medical Device Regulations (EU MDR), but there was little support to align with the International Medical Device Regulators Forum (IMDRF) essential principles and principles of labeling.
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).
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).
PERTH, Australia – Aussie biotech CSL Ltd. and the University of Queensland (UQ) have entered a development agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to accelerate development, manufacture and distribution of a COVID-19 vaccine candidate developed by the University of Queensland.
PERTH, Australia – CSL Ltd. said its subsidiary, CSL Behring, has agreed to exercise an option to acquire Canadian biotech Vitaeris Inc. for its lead phase III asset for rejection in solid organ kidney transplant patients.
