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BioWorld - Sunday, July 3, 2022
Home » Topics » Asia-Pacific » Australia

Australia
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Gastric cancer

Imugene reports positive final overall survival data in phase II HER-Vaxx gastric cancer trial

June 29, 2022
By Tamra Sami
No Comments
Immuno-oncology company Imugene Ltd. reported median overall survival for patients receiving HER-Vaxx plus chemotherapy was 13.9 months compared to 8.3 months in patients treated with chemotherapy alone in its phase II study in HER2/neu overexpressing advanced gastric cancer.
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Against the tide, Australia allows advertising COVID-19 antiviral drugs

June 28, 2022
By Tamra Sami
No Comments
In a rare move, Australia’s Therapeutic Goods Administration is allowing two prescription-only COVID-19 treatments to be advertised to the public.
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FDA Not Approved stamp

FDA rejects Artrya’s 510(k) for its AI-enabled Salix coronary anatomy software

June 24, 2022
By Tamra Sami
No Comments
The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
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Against the tide, Australia allows advertising COVID-19 antiviral drugs

June 23, 2022
By Tamra Sami
No Comments
In a rare move, Australia’s Therapeutic Goods Administration is allowing two prescription-only COVID-19 treatments to be advertised to the public.
Read More
Heart and kidneys
Newco news

Vectus shows lead candidate reverses heart, kidney fibrosis

June 16, 2022
By Tamra Sami
No Comments
From 20 years of research on metabolic change as a result of salt intake, Karen Duggan discovered in 2003 that a naturally occurring molecule in the human body, native vasoactive intestinal peptide (VIP), was capable of reversing fibrosis caused by hypertension and other chronic diseases such as diabetes. From that discovery, Vectus Biosystems Ltd. was founded, and the company has developed a new class of mimetic drug candidates and a drug library based on VIP.
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Orthocell reports final data on Remplir nerve reconstruction study

June 8, 2022
By Tamra Sami
No Comments
Regenerative medicine company Orthocell Ltd. reported final data from its nerve reconstruction study that showed patients continued to improve between 12- and 24-months post-treatment with regenerative nerve repair device Remplir.
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Microchip robotic manufacturing concept
ANDHealth Digital Health Summit:

Big pharma sees digital medicine as core to its strategy, but clarity needed on data use, consent

May 31, 2022
By Tamra Sami
No Comments
Pharma companies agree that data is king, since after all, their drugs get approved based on the quality of their data.
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Ausmedtech 2022

Australia plans more consumer-focused device reforms

May 26, 2022
By Tamra Sami
No Comments
Australia’s Therapeutic Goods Administration (TGA) has made a range of changes to its medical device regulations in recent years that have largely been driven by the need to keep pace with changing technologies, TGA head John Skerritt said during the Ausmedtech 2022 annual conference in Melbourne, Australia.
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ANDHealth Digital Health Summit:

Big pharma sees digital medicine as core to its strategy, but clarity needed on data use, consent

May 25, 2022
By Tamra Sami
No Comments
Pharma companies agree that data is king, since after all, their drugs get approved based on the quality of their data.
Read More
Map of Australia as blue circuit board, digital network

Australia to begin routine GCP inspections for clinical trial sites

May 3, 2022
By Tamra Sami
No Comments
Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections.
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