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BioWorld - Tuesday, June 16, 2026
Home » Topics » Regulatory » TGA

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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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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
Illustration of brain with electrical activity background

Brain Trust Bio’s drug delivery method to be tested in Australia

April 23, 2024
By Tamra Sami
Brain Trust Bio Inc. (BTB) will soon begin phase I trials in Australia of its IT-Riluzole delivered to the brain via a continuous intrathecal drug delivery method in people with amyotrophic lateral sclerosis. The company’s concept is to take known drugs that work and make them better by delivering them exclusively to where patients need them most, BTB co-founder and CEO Chen Benkler told BioWorld.
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Brain Trust Bio’s drug delivery method to be tested in Australia

April 23, 2024
By Tamra Sami
Brain Trust Bio Inc. (BTB) will soon begin phase I trials in Australia of its IT-Riluzole delivered to the brain via a continuous intrathecal drug delivery method in people with amyotrophic lateral sclerosis. The company’s concept is to take known drugs that work and make them better by delivering them exclusively to where patients need them most, BTB co-founder and CEO Chen Benkler told BioWorld.
Read More
Illustration of brain with electrical activity background

Brain Trust Bio’s drug delivery method to be tested in Australia

April 22, 2024
By Tamra Sami
Brain Trust Bio Inc. (BTB) will soon begin phase I trials in Australia of its IT-Riluzole delivered to the brain via a continuous intrathecal drug delivery method in people with amyotrophic lateral sclerosis. The company’s concept is to take known drugs that work and make them better by delivering them exclusively to where patients need them most, BTB co-founder and CEO Chen Benkler told BioWorld.
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Child drawing with pencil

Neurotech’s NTI-164 meets endpoints in pediatric autism trial

April 17, 2024
By Tamra Sami
Neurotech International Ltd.’s cannabinoid NTI-164 met the primary and secondary endpoints in a phase II/III trial in children with autism spectrum disorder. The company also reported positive top-line data for Rett syndrome in a phase I/II trial.
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