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.

PERTH, Australia – Australian cell therapy developer Mesoblast Ltd. has completed a AU$75 million (US$50.32 million) capital raising via an oversubscribed placement to existing and new Australian and global institutional investors.

PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is seeking comments from stakeholders on whether certain self-testing in vitro diagnostics (IVDs) should be prohibited from being sold to consumers.

PERTH, Australia – Australia is at risk of falling behind the U.S. and Europe in preventing recurrence of melanoma, the Melanoma Institute Australia warns. It is urging the Australian government to undertake a timely review of immunotherapy treatments effective in preventing the spread of melanoma and to fast track listings on the government-subsidized Pharmaceutical Benefits Scheme (PBS).

PERTH, Australia – Melbourne-based regenerative medicine company Cynata Therapeutics Ltd. is enjoying a bit of hot pursuit as Fujifilm Corp. exercised its license option to develop and commercialize Cynata's lead Cymerus mesenchymal stem cell (MSC) product, CYP-001, for graft-vs.-host disease (GVHD) at the same time that Cynata is an acquisition target by Dainippon Sumitomo.

Melbourne, Australia-based regenerative medicine company Avita Medical Ltd. has received good news from the FDA. The company, which also has a presence in Valencia, Calif., said the agency gave its thumbs up to an investigational device exemption application for a pivotal trial (NCT04091672) evaluating the safety and effectiveness of the Recell autologous cell harvesting device in combination with meshed autografting for the treatment of acute full-thickness skin defects, such as degloving, crush wounds, abrasions, lacerations and surgical wounds.

PERTH, Australia – The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal that to change Australia's medical device essential principles for safety and performance to more closely mirror the new EU Medical Device Regulation (EU MDR).