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BioWorld - Tuesday, July 7, 2026
Home » Topics » Asia-Pacific » Australia

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Brain activity concept illustration
Newco news

Enveric Biosciences gears up for phase I anxiety trial with psilocin prodrug

June 27, 2023
By Tamra Sami
Enveric Biosciences Inc. is gearing up to begin clinical trials in generalized anxiety disorder with lead candidate, EB-373, a psilocin prodrug. Trials are expected to begin in the fourth quarter of 2023.
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Urinary tract with kidneys, adrenalin glands, ureter and vessels on light blue background

Telix expands urology pipeline with $35M acquisition of Lightpoint Medical

June 27, 2023
By Tamra Sami
Telix Pharmaceuticals Ltd. will acquire Lightpoint Medical Ltd. in a $35 million deal that will expand its urology pipeline and bring in house a new surgery-focused unit. Under the terms of the deal, Telix of Melbourne, Australia, will pay Lightpoint $20 million up front and a further $15 million on achievement of certain development milestones. The up-front payment will be paid in equity, and the additional milestones will be payable in cash or equity, at Telix’s election.
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Brain activity concept illustration
Newco news

Enveric Biosciences gears up for phase I anxiety trial with psilocin prodrug

June 22, 2023
By Tamra Sami
Enveric Biosciences Inc. is gearing up to begin clinical trials in generalized anxiety disorder with lead candidate, EB-373, a psilocin prodrug. Trials are expected to begin in the fourth quarter of 2023.
Read More
Urinary tract with kidneys, adrenalin glands, ureter and vessels on light blue background

Telix expands urology pipeline with $35M acquisition of Lightpoint Medical

June 22, 2023
By Tamra Sami
Telix Pharmaceuticals Ltd. will acquire Lightpoint Medical Ltd. in a $35 million deal that will expand its urology pipeline and bring in house a new surgery-focused unit. Under the terms of the deal, Telix of Melbourne, Australia, will pay Lightpoint $20 million up front and a further $15 million on achievement of certain development milestones. The up-front payment will be paid in equity, and the additional milestones will be payable in cash or equity, at Telix’s election.
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TGA eyes mutual recognition with EU for in vitro diagnostics

June 21, 2023
By Mark McCarty
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
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Avita Recell device

Avita’s Recell gains FDA greenlight for skin repigmentation in vitiligo

June 21, 2023
By Tamra Sami
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.
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Coin inserted into Australian map
Newco news

Argenica raises AU$4M to advance neuroprotective agent in ischemic stroke

June 20, 2023
By Tamra Sami
After raising AU$4 million (US$2.6 million), Argenica Therapeutics Pty. Ltd. is gearing up to begin phase II trials in ischemic stroke for ARG-007, a glutamate receptor modulator that is believed to reduce brain tissue death after stroke.
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Coin inserted into Australian map
Newco news

Argenica raises AU$4M to advance neuroprotective agent in ischemic stroke

June 19, 2023
By Tamra Sami
After raising AU$4 million (US$2.6 million), Argenica Therapeutics Pty. Ltd. is gearing up to begin phase II trials in ischemic stroke for ARG-007, a glutamate receptor modulator that is believed to reduce brain tissue death after stroke.
Read More
Tracey Duffy speaking at podium

Consumer and industry engagement guide Australia’s device reforms

June 8, 2023
By Tamra Sami
Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure patient safety, said Tracey Duffy, deputy secretary for the TGA’s Medical Devices and Product Quality Division, during the recent Ausmedtech conference in Adelaide.
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Joel Latham, CEO, Incannex Healthcare Ltd.
Newco news

Incannex is changing treatment paradigms with pipeline of psychedelics and cannabinoids

June 6, 2023
By Tamra Sami
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
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