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BioWorld - Saturday, December 27, 2025
Home » Topics » Asia-Pacific » Australia

Australia
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Avita Recell device

FDA grants breakthrough device designations to Avita’s Recell device for soft tissue repair, vitiligo

Nov. 9, 2022
By Tamra Sami
Avita Medical Ltd.’s Recell system won FDA breakthrough device designations in soft tissue repair and vitiligo. Melbourne-headquartered Avita, a regenerative medicine company developed the Recell system, a technology platform that enables point-of-care autologous skin restoration.
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Ausbiotech 2022: Japan offers model for building sustainable regenerative sector

Nov. 8, 2022
By Tamra Sami
“We look at Japan with some envy with what they’ve been able to achieve and their approach to regenerative medicine, which has been supported significantly by their federal government,” said Silvio Tiziano, CEO of the Center for the Commercialization of Regenerative Medicine Australia, during the recent Ausbiotech conference in Perth.
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Kidneys

Telix’s imaging agent meets primary, secondary endpoints in phase III kidney cancer trial

Nov. 8, 2022
By Tamra Sami
Radiopharmaceutical company Telix Pharmaceuticals Ltd’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data.
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Telix’s imaging agent meets primary, secondary endpoints in phase III kidney cancer trial

Nov. 7, 2022
By Tamra Sami
Radiopharmaceutical company Telix Pharmaceuticals Ltd’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data.
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Psychedelic drug illustration

Ausbiotech 2022: Psychedelics coming to clinics in Australia

Nov. 1, 2022
By Tamra Sami
The potential for psychedelics to deliver long-lasting benefits for people with anxiety, depression, post-traumatic stress disorder and addiction is being put to the test in Australia, where new research and discovery centers are adding to a global enterprise of nearly 100 clinical trials underway in the space.
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Ausbiotech 2022: Psychedelics coming to clinics in Australia

Oct. 28, 2022
By Tamra Sami
The potential for psychedelics to deliver long-lasting benefits for people with anxiety, depression, post-traumatic stress disorder and addiction is being put to the test in Australia, where new research and discovery centers are adding to a global enterprise of nearly 100 clinical trials underway in the space.
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Flag of Australia, sky background

TGA clarifies regulatory pathways for drug-device combination products

Oct. 18, 2022
By Tamra Sami
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
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Colorful illustration of the heart

Rainmed wins Australian approval for coronary artery diseases diagnostic

Oct. 18, 2022
By David Ho
Rainmed Medical Ltd.'s coronary angiography-derived fractional flow reserve system (caFFR system) was approved by Australia’s TGA for precision diagnosis of coronary artery diseases.
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Cancer

University of Queensland researchers receive funding for research in mRNA and cancer vaccines

Oct. 17, 2022
Researchers at the University of Queensland have been awarded funding to advance work across mRNA research, cancer vaccines and single-cell genomic technologies.
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Flag of Australia, sky background

TGA clarifies regulatory pathways for drug-device combination products

Oct. 12, 2022
By Tamra Sami
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
Read More
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