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BioWorld - Sunday, December 7, 2025
Home » Topics » Asia-Pacific » Australia

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Immutep raises AU$29M to broaden immuno-oncology clinical programs

Nov. 24, 2020
By Tamra Sami
PERTH, Australia – Immutep Ltd. completed a AU$29.6 million (US$21.72 million) placement that will allow the immunotherapy company to accelerate and broaden clinical development of its immuno-oncology and autoimmune programs.
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Australia’s Imugene shows positive overall survival in ongoing phase II gastric cancer trial

Nov. 23, 2020
By Tamra Sami
PERTH, Australia – Sydney-based Imugene Ltd.’s stock shot up 15% on news that an interim analysis of phase II data in its B-cell peptide vaccine, HER-Vaxx, in advanced gastric cancer showed positive survival data.
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Flag of Australia, sky background

TGA pushes back some device reforms but moves ahead with SaMD and UDI updates

Nov. 20, 2020
By Tamra Sami
PERTH, Australia – It was already going to be a busy year for Australia’s Therapeutic Goods Administration (TGA) as it planned to implement the final wave of device reforms in 2020 before the COVID-19 pandemic hit. The delay to the EU Medical Device Regulation (MDR) as a result of the pandemic will mean that Australia will also push back many of its device reforms for another year, said John Skerritt, the TGA’s deputy secretary of the Health Products Regulation Group.
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Respiratory infection

Mesoblast licenses remestemcel-L to Novartis in deal worth up to $1.3B

Nov. 20, 2020
By Tamra Sami
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
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Drugs-in-space-CubeLab-pic-11-19

University of Adelaide begins space odyssey into pharmaceutical stability

Nov. 19, 2020
By Tamra Sami
PERTH, Australia – As the idea of going to Mars starts to look less far-fetched, scientists are beginning to ask practical questions about how space affects the stability of drugs.
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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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