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.
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 – 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).
Prescient Therapeutics Pty Ltd. is poised to develop next-generation CAR T therapies after signing a deal with the University of Pennsylvania for a universal immune receptor technology platform.
PERTH, Australia – Melbourne-based Prescient Therapeutics Pty Ltd. is poised to develop next-generation CAR T therapies after signing an exclusive global licensing deal with the University of Pennsylvania for a universal immune receptor technology platform.
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. has submitted a 510(k) application to the U.S. FDA for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The submission follows positive results from an FDA-guided bone regeneration study, which is a key component toward the goal of gaining U.S. marketing approval.
