PERTH, Australia – Micro-X Ltd. completed an AU$30.5 million (US$23.27 million) placement to expand its U.S. footprint for its lightweight digital mobile X-ray systems. The funds raised will drive market expansion of Adelaide, Australia-based Micro-X’s Rover digital mobile X-ray system that is designed for deployed military medical facilities, and to scale up its Carestream DRX Revolution Nano, a mobile lightweight digital X-ray system for hospitals.
PERTH, Australia –Digital diagnostics company Ellume Ltd. announced a US$231.8 million agreement with the U.S. Department of Defense (DoD), in coordination with the Department of Health and Human Services (HHS), to accelerate domestic U.S. production of its COVID-19 home tests. The agreement includes funding to support the establishment of Ellume’s U.S.-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests that will be distributed across the U.S.
PERTH, Australia – Sydney-based Immutep Ltd. announced that Glaxosmithkline plc is discontinuing a phase II ulcerative colitis trial of its anti-lymphocyte activation gene-3 cell-depleting monoclonal antibody, derived from Immutep’s IMP-731 antibody that GSK licensed in 2010.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia.
PERTH, Australia – Sydney-based Cyclopharm Ltd. raised AU$30 million (US$23.19 million) in a private placement that will enable the company to launch its Technegas combination product in the U.S.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia.
PERTH, Australia – Following consultation with medical device stakeholders in 2019 and 2020, the Therapeutic Goods (Medical Devices) Regulations 2002 were amended to clarify some existing requirements and to introduce new requirements for software-based medical devices. The new rules that go into effect on Feb. 25, 2021, clarify the boundary of regulated software products, introduce new classification rules, and provide updates to the essential principles for software-based medical devices.
PERTH, Australia – Sydney-based Immutep Ltd. announced that partner Glaxosmithkline plc is discontinuing a phase II ulcerative colitis trial of its anti-lymphocyte activation gene-3 (LAG-3) cell-depleting monoclonal antibody, derived from Immutep’s IMP-731 antibody that GSK licensed in 2010.
PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey.
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. saw its shares rise 27% on the heels of its first U.S. approval for its collagen medical device for dental guided bone and soft tissue regeneration applications. “It’s an important milestone for us, and one that came quicker than I was expecting it to come,” Orthocell CEO Paul Anderson told BioWorld. The company submitted its 510(k) application to the FDA in May, and he was expecting approval by the middle of 2021.
