PERTH, Australia – Although medical device industry stakeholders agreed in principle with the Australian Therapeutic Goods Administration's (TGA) proposal to align its classification with the EU's for implantable spinal devices, they viewed the interpretation of the EU Medical Device Regulation (MDR) classification rule for these devices differently.
Although Australia's Therapeutic Goods Administration (TGA) approved its first CAR T therapy in 2018, the country is lacking a system to reimburse those advanced therapies, and industry is calling on government to revalue gene therapies.
PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. is poised to extend its global footprint to the U.S. and Europe following its AU$35 million (US$24 million) capital raise.
HONG KONG – South Korean biopharma Virocure Inc., based in Seoul, recently founded a local corporation in Brisbane, Australia. The new company, Virocure Australia Pty Ltd., will facilitate a phase I trial of the experimental cancer drug RC-402 in Australia.
Australian scientists have discovered promising new candidate analgesic molecules derived from a Penicillium fungus, which represents a promising resource for the development of safer new analgesics, they reported in the Oct. 14, 2019, edition of Proceedings of the National Academy of Sciences.
Australian scientists have discovered promising new candidate analgesic molecules derived from a Penicillium fungus, which represents a promising resource for the development of safer new analgesics, they reported in the Oct. 14, 2019, edition of Proceedings of the National Academy of Sciences (PNAS).
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is taking regulatory action in relation to all un-implanted breast implants and tissue expanders sold in that country. Those actions include suspension and recall of products, removal from the market and additional requirements for supply of products.
PERTH, Australia – Following stunning interim clinical results for its Celgro nerve regeneration treatment in quadriplegic patients, regenerative medicine company Orthocell Ltd. will focus all its efforts on gaining early FDA approval based on the early results.
Australian digital medication management company Medadvisor Ltd. raised AU$17 million (US$11.4 million) via an oversubscribed placement in which U.S. health care solution provider HMS Holdings Corp. was a cornerstone investor, putting up $11 million and becoming the firm's largest shareholder with a 13% stake in the digital health company.