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BioWorld - Tuesday, December 16, 2025
Home » Topics » Regulatory » TGA

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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.
Read More
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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Neurology/Psychiatric

Xgene gains Australian clearance for phase I study of XG-2002

March 14, 2024
Xgene Pharmaceutical Pty Ltd., a subsidiary of Xgene Pharmaceutical Co. Ltd., has received approval in Australia to initiate a phase I trial of the selective TRPM8 blocker XG-2002 (RQ-00434739).
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Art concept for gene therapy research
Neurology/Psychiatric

Encoded Therapeutics’ gene therapy for SCN1A+ Dravet syndrome gets clinical green light in US and Australia

Feb. 6, 2024
Encoded Therapeutics Inc. is advancing its lead gene therapy candidate, ETX-101, for the treatment of SCN1A+ Dravet syndrome into the clinic.
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Futuristic medicine research illustration with petri dishes and pipette
Infection

Asieris Pharmaceuticals obtains approval to conduct phase I study of antibacterial drug

Dec. 27, 2023
Asieris Pharmaceuticals Co. Ltd. announced that it has received approval to commence phase I clinical trials in Australia of its novel antibacterial drug, APL-2301 (ASN-1733, MET-102), under development for the treatment of Acinetobacter baumannii infections.
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Endocrine/Metabolic

Iecure’s ECUR-506 cleared to enter clinic in Australia for OTC deficiency

Dec. 14, 2023
Iecure Inc. has received clearance from the Australian Therapeutic Goods Administration (TGA) of the company’s clinical trial notification (CTN) for ECUR-506 (formerly GTP-506), an investigational therapy in development for the treatment of ornithine transcarbamylase (OTC) deficiency in pediatric (or neonatal) patients.
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Ausbiotech 2023: Big pharma sees promise in building mRNA platform in Australia to serve APAC

Nov. 7, 2023
By Tamra Sami
Multinational pharma companies like Moderna Inc. and Sanofi SA are setting up mRNA R&D centers in Australia and are banking on the country’s decades of mRNA expertise to bring new therapeutics to the clinic and to serve as regional hubs in Asia Pacific, speakers said during the Ausbiotech 2023 conference held Nov 1-3 in Brisbane, Australia.
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Ausbiotech 2023: Big pharma sees promise in building mRNA platform in Australia to serve APAC

Nov. 6, 2023
By Tamra Sami
Multinational pharma companies like Moderna Inc. and Sanofi SA are setting up mRNA R&D centers in Australia and are banking on the country’s decades of mRNA expertise to bring new therapeutics to the clinic and to serve as regional hubs in Asia Pacific, speakers said during the Ausbiotech 2023 conference held Nov 1-3 in Brisbane, Australia.
Read More
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