PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre.
PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre.
PERTH, Australia – Australia’s largest life science investment fund is pressing the government for an urgent COVID-19 response package to support the country’s AU$170 billion (US$117 billion) life sciences sector that is struggling to survive in a post-COVID-19 ecosystem.
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 – Roughly 40% of Australia’s biotech companies are seeking capital as they feel the pinch from international travel bans that seriously hamper capital raising, according to a recent Ausbiotech survey.
PERTH, Australia – Roughly 40% of Australia’s biotech companies are seeking capital as they feel the pinch from international travel bans that seriously hamper capital raising, according to a recent Ausbiotech survey.
PERTH, Australia – Despite a Senate inquiry recommendation to hold off on introducing cuts to Australia’s Research and Development Tax Incentive (RDTI), a bill that recommends cuts was introduced in Parliament, sending shudders through the biotech industry. “Ausbiotech is deeply concerned that the RDTI Bill has been reintroduced, despite the Senate Committee’s recommendations to defer consideration of the bill until further examination and analysis of the impact is undertaken,” said Ausbiotech CEO Lorraine Chiroiu.
PERTH, Australia – Industry was supportive of most of the changes proposed by Australia’s Therapeutic Goods Administration (TGA) for custom-made and 3D-printed devices. However, the comments also indicated that the current regulatory requirements for custom-made devices are not well understood. The agency stressed that increasing use of 3D printing for medical applications is raising questions about the adequacy of the current medical device regulatory framework to mitigate risks to patients.
Device makers were generally supportive of the Australian Therapeutic Goods Administration (TGA) proposal to up-classify active medical devices with an integrated diagnostic function that significantly determines patient management by the device (such as closed loop systems or automated external defibrillators) to class III, the highest risk designation used by TGA.
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.
