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BioWorld - Saturday, December 13, 2025
Home » Topics » Regulatory » TGA

TGA
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Wegovy available in Australia; hefty price likely to deter use

Aug. 15, 2024
By Tamra Sami
In the wake of shortages for Novo Nordisk A/S’ Ozempic (semaglutide), Australia’s Therapeutic Goods Administration has announced that Wegovy, which has the same active ingredient, is now available in Australia and is advising prescribers to stop prescribing Ozempic off-label for weight loss.
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Eye and DNA illustration
Ocular

Rznomics gains Australian clearance to advance RZ-004 into clinic for retinitis pigmentosa

July 15, 2024
Rznomics Inc. has received clinical trial notification (CTN) from Australia’s Therapeutic Goods Administration (TGA) for the initiation of a phase I/IIa trial evaluating RZ-004, a gene therapeutic candidate for autosomal dominant retinitis pigmentosa with rhodopsin mutation.
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Spectral AI Deepview system

Spectral AI collaborates with Polynovo to test wound healing device

July 12, 2024
By Tamra Sami
AI-focused medical diagnostics company Spectral AI Inc. is collaborating with burn wound therapy company Polynovo Ltd. to test limited deployment of Spectral’s Deepview system for predicting burn healing in Australia.
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Pill in immersive interface
Neurology/psychiatric

Satellos files in Australia to begin clinical testing of SAT-3247 for Duchenne muscular dystrophy

July 12, 2024
Satellos Bioscience Inc. has submitted a clinical research proposal to a Human Research Ethics Committee (HREC) in Australia seeking regulatory authorization under the Therapeutic Goods Administration (TGA)’s clinical trial notification scheme to conduct a first-in-human phase I trial of SAT-3247.
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DNA in drug capsules
Immuno-oncology

Interius’ INT-2104 receives Australian clearances for clinical trial in B-cell malignancies

July 9, 2024
Interius Biotherapeutics Inc. has been granted Human Research Ethics Committee (HREC) approval and clinical trial notification clearance by Australia’s Therapeutic Goods Administration (TGA) to begin a first-in-human trial of INT-2104, its lead in vivo CAR candidate for treatment of B-cell malignancies.
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Flag of Australia, sky background

Australia poised to harness the power of radiopharmaceuticals

May 7, 2024
By Tamra Sami
Australia is poised to play a leading role in the rise of the global radiopharmaceutical industry, as advanced therapies drive significant investment and rapid expansion, according to a new discussion paper from industry accelerator Mtpconnect.
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Coin inserted into Australian map

Australia investing AU$1.89B for new research, clinical trials

May 7, 2024
By Tamra Sami
The Australian government is investing AU$1.89 billion (US$1.25 billion) in what it is calling a “once-in-a generation transformation” of health and medical research in Australia with $1.4 billion tagged for new research for the Medical Research Future Fund.
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Regulatory icons

Mexico’s COFEPRIS adds SaMD to definitions in revised labeling rule

May 7, 2024
By Mark McCarty
Mexico’s Federal Commission for Protection Against Sanitary Risk (COFEPRIS) has released a draft proposal that would overhaul the 2008 version of the rule for device labeling, a document that includes several key proposed reforms.
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Coin inserted into Australian map

Australia investing AU$1.89B for new research, clinical trials

May 6, 2024
By Tamra Sami
The Australian government is investing AU$1.89 billion (US$1.25 billion) in what it is calling a “once-in-a generation transformation” of health and medical research in Australia with $1.4 billion tagged for new research for the Medical Research Future Fund.
Read More
Flag of Australia, sky background

Australia poised to harness the power of radiopharmaceuticals

May 3, 2024
By Tamra Sami
Australia is poised to play a leading role in the rise of the global radiopharmaceutical industry, as advanced therapies drive significant investment and rapid expansion, according to a new discussion paper from industry accelerator Mtpconnect.
Read More
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