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BioWorld - Monday, July 13, 2026
Home » Topics » Regulatory » TGA

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Illustration of Bellaseno's scaffold placed in the breast

Bellaseno speeds breast scaffold trial as J&J deal clears path to market

July 7, 2026
By Tamra Sami
No Comments
Regenerative medicine company Bellaseno GmbH is accelerating development of its absorbable breast scaffold, with a pivotal Australian trial recruiting faster than expected and a newly announced licensing deal with Johnson & Johnson subsidiary Mentor Worldwide LLC positioning the technology for global commercialization.
Read More
Illustration of Bellaseno's scaffold placed in the breast

Bellaseno speeds breast scaffold trial as J&J deal clears path to market

July 2, 2026
By Tamra Sami
No Comments
Regenerative medicine company Bellaseno GmbH is accelerating development of its absorbable breast scaffold, with a pivotal Australian trial recruiting faster than expected and a newly announced licensing deal with Johnson & Johnson subsidiary Mentor Worldwide LLC positioning the technology for global commercialization.
Read More
Ausbiotech panel - Tracy-Duffy (far left)

AI, remote care drive new models for Australian medtech

May 26, 2026
By Tamra Sami
No Comments
Artificial intelligence, remote monitoring and need-based innovation are beginning to reshape Australia’s medtech sector’s devices, as well as the way health care itself is delivered, according to speakers at the 2026 Ausmedtech conference in Perth May 19-20.
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3D illustration showing presence of tumor inside prostate gland
Immuno-oncology

Henlius gains Australian trial clearance for HLX-3902

May 22, 2026
No Comments
Shanghai Henlius Biotech Inc.’s HLX-3902, a trispecific antibody targeting STEAP1xCD3xCD28, has received approval from the Human Research Ethics Committee (HREC) in Australia and has been filed with the Therapeutic Goods Administration (TGA). The T-cell engager is intended for the treatment of metastatic castration-resistant prostate cancer and other advanced solid tumors.
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Cardiovascular

Scribe’s STX-1150 for hypercholesterolemia cleared for clinic

May 22, 2026
No Comments
Scribe Therapeutics Inc. has obtained clearance from Australia’s Therapeutic Goods Administration (TGA) to initiate a first-in-human study of STX-1150 for the treatment of hypercholesterolemia, a major driver of atherosclerotic cardiovascular disease (ASCVD). The phase I study will enroll adults with elevated LDL-C at increased cardiovascular risk at sites in Australia and New Zealand.
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Ausbiotech panel - Tracy-Duffy (far left)

AI, remote care drive new models for Australian medtech

May 21, 2026
By Tamra Sami
No Comments
Artificial intelligence, remote monitoring and need-based innovation are beginning to reshape Australia’s medtech sector’s devices, as well as the way health care itself is delivered, according to speakers at the 2026 Ausmedtech conference in Perth May 19-20.
Read More
3D illustration of tumor
Immuno-oncology

Henlius’ HLX-48 for solid tumors cleared for clinic in Australia

May 14, 2026
No Comments
Shanghai Henlius Biotech Inc.’s HLX-48 for injection has received approval from the Human Research Ethics Committee (HREC) in Australia and been acknowledged by the Therapeutic Goods Administration (TGA). The first-in-human phase I study in Australia will evaluate HLX-48 in patients with advanced or metastatic solid tumors.
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White tablet imprinted with dollar sign

Pricing standoff leaves Australian patients in limbo

April 21, 2026
By Tamra Sami
No Comments
A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit.
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White tablet imprinted with dollar sign

Pricing standoff leaves Australian patients in limbo

April 15, 2026
By Tamra Sami
No Comments
A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit.
Read More
Tape measure, apple on scale
Endocrine/metabolic

Ibio’s IBIO-600 cleared to enter clinic in Australia for obesity

April 9, 2026
No Comments
Ibio Inc. has received clinical trial notification (CTN) acknowledgement from Australia’s Therapeutic Goods Administration (TGA), as well as Human Research Ethics Committee approval, for IBIO-600, enabling the initiation of a first-in-human trial in Australia.
Read More
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