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BioWorld - Saturday, June 13, 2026
Home » Topics » Asia-Pacific » Australia

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Regulatory front

TGA hits pause on two consultations

Nov. 18, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HQO recommends home UVB therapy; Health Canada announces testing advisory panel.
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Australian flag on laptop screen with health professional
Australia’s National Digital Health Initiative

Australia’s distance not a disadvantage when it comes to digital health technologies

Nov. 13, 2020
By Tamra Sami
PERTH, Australia – The COVID-19 pandemic has highlighted the importance of digital health technology, and the Australian government quickly enabled programs in telehealth and e-prescriptions. It now is embracing opportunities to build on this momentum to accelerate the country’s economic digital transformation. Not only will this transformation contribute to Australia’s recovery, but also to its long-term prosperity, said Sue MacLeman, chair of Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre (MTPConnect), during a recent ANDHealth teleconference.
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Coronavirus cash

Gbs looking to raise $20M in Nasdaq IPO to develop noninvasive SARS-CoV-2 diagnostic

Nov. 10, 2020
By Tamra Sami
PERTH, Australia – Gbs Inc. reported filing an initial public offering on the Nasdaq for $20 million, as the company looks to launch the first noninvasive SARS-Cov-2 test. A subsidiary of Sydney-based The Iq Group Ltd. (NSX:IQG), Delaware-based Gbs has developed a biosensor platform that enables real-time diagnostic point-of-care (POC) tests, and the funds raised will enable the company to launch its SARS- CoV-2 test and a saliva glucose test.
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Clinuvel stroke illustration

Clinuvel announces new indications for Scenesse

Nov. 3, 2020
By Tamra Sami
PERTH, Australia – Clinuvel Pharmaceuticals Ltd. announced two new pharmaceutical indications for its lead product, Scenesse (afamelanotide). “The company has until now focused on one drug and has slowly gathered evidence and is now in a position to add other products to its pipeline,” Clinuvel CEO Philippe Wolgen told BioWorld.
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Nasdaq building

Australia’s Opthea lists on Nasdaq in $128M IPO, gears up for phase III wet AMD trials

Nov. 3, 2020
By Tamra Sami
PERTH, Australia – Opthea Ltd. completed a $128.2 million IPO on the U.S. Nasdaq market, which will fund two phase III trials in wet age-related macular degeneration (AMD) and bring the company’s lead candidate, OPT-302, to market if successful.
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Clinuvel stroke illustration

Clinuvel announces new indications for Scenesse

Oct. 30, 2020
By Tamra Sami
PERTH, Australia – Clinuvel Pharmaceuticals Ltd. announced two new pharmaceutical indications for its lead product, Scenesse (afamelanotide). “The company has until now focused on one drug and has slowly gathered evidence and is now in a position to add other products to its pipeline,” Clinuvel CEO Philippe Wolgen told BioWorld.
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Nasdaq building

Australia’s Opthea lists on Nasdaq in $128M IPO, gears up for phase III wet AMD trials

Oct. 28, 2020
By Tamra Sami
PERTH, Australia – Opthea Ltd. completed a $128.2 million IPO on the U.S. Nasdaq market, which will fund two phase III trials in wet age-related macular degeneration (AMD) and bring the company’s lead candidate, OPT-302, to market if successful.
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Close-up of eye

Azura Ophthalmics raises $20M series C for registration study in Meibomian gland dysfunction

Oct. 27, 2020
By Tamra Sami
PERTH, Australia – Azura Ophthalmics Ltd. raised a $20 million series C round with existing investors, including Brandon Capital’s Medical Research Commercialization Fund (MRCF), Orbimed, TPG Biotech and Ganot Capital.
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Australia’s Actinogen advances lead compound Xanamem in Alzheimer’s disease, fragile X syndrome

Oct. 27, 2020
By Tamra Sami
PERTH, Australia – Sydney-based Actinogen Medical Ltd. will advance its lead compound, Xanamem, into two proof-of-concept phase II studies in Alzheimer’s disease and fragile X syndrome.
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Brain with puzzle piece removed

Cogstate sells global rights for cognitive function tests to Eisai for $45M

Oct. 27, 2020
By Tamra Sami
PERTH, Australia – Neuroscience technology company Cogstate Ltd. and Japanese pharmaceutical company Eisai Co. Ltd. signed a deal under which Eisai will have global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate, including the Cogstate Brief Battery (CBB) for use in health care and other markets.
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