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BioWorld - Friday, December 19, 2025
Home » Topics » Asia-Pacific » Australia

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Australia unveils new companion diagnostics regulatory framework

Dec. 24, 2019
By Tamra Sami
Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February. Until now, Australia did not have a framework for CDx.
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Liver disease

Boehringer Ingelheim quits development of Pharmaxis drug for NASH indication

Dec. 24, 2019
By Tamra Sami
PERTH, Australia – Boehringer Ingelheim GmbH is discontinuing development of BI-1467335 for the treatment of nonalcoholic steatohepatitis (NASH) that it acquired from Sydney-based Pharmaxis Ltd. in 2015.
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Australia unveils new companion diagnostics regulatory framework

Dec. 23, 2019
By Tamra Sami
Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February. Until now, Australia did not have a framework for CDx.
Read More
Globe showing Australia

Australia unveils new companion diagnostics regulatory framework

Dec. 23, 2019
By Tamra Sami
Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February.
Read More

Boehringer Ingelheim quits development of Pharmaxis drug for NASH indication

Dec. 18, 2019
By Tamra Sami
PERTH, Australia – Boehringer Ingelheim GmbH is discontinuing development of BI-1467335 for the treatment of nonalcoholic steatohepatitis (NASH) that it acquired from Sydney-based Pharmaxis Ltd. in 2015.
Read More

Chinese investors launch new AU$45M fund to develop South Australian biotech

Dec. 17, 2019
By Tamra Sami
PERTH, Australia – Private Chinese investors have launched a new AU$45 million (US$31.17 million) investment fund to accelerate the development and commercialization of new biotechnology from South Australia for the global market.
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Chinese investors launch new AU$45M fund to develop South Australian biotech

Dec. 16, 2019
By Tamra Sami
PERTH, Australia – Private Chinese investors have launched a new AU$45 million (US$31.17 million) investment fund to accelerate the development and commercialization of new biotechnology from South Australia for the global market. The Adelaide China Biotech Investment Fund is backed by a group of private investors based in Nanjing, China, underwritten by the Bank of Nanjing.
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Australia’s R&D tax incentive threatened yet again

Dec. 10, 2019
By Tamra Sami
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.
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Australia’s R&D tax incentive threatened yet again

Dec. 10, 2019
By Tamra Sami
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. 
Read More

TGA goes back to the drawing board again with guidance on custom-made and 3D-printed devices

Dec. 6, 2019
By Tamra Sami
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.
Read More
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