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.

PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.

PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.

PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. received marketing clearance from Australia’s Therapeutic Goods Administration (TGA) for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The approval validates the Celgro platform technology and clears the way for further approvals in nerve and tendon repair, Orthocell CEO Paul Anderson told BioWorld.

PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure.

PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure, revealing a number of strengths that the agency will build upon, the TGA said in its annual performance report.