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BioWorld - Sunday, May 22, 2022
Home » Topics » Asia-Pacific » Australia

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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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Australia to begin routine GCP inspections for clinical trial sites

April 29, 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.
Read More
Fallopian tubes, ovaries and uterus

Inoviq expands collaboration with UQ to develop exosome-based ovarian cancer screening test

April 22, 2022
By Tamra Sami
No Comments
Inoviq Ltd. and The University of Queensland (UQ) are expanding a collaboration to develop an exosome-based ovarian cancer screening test. Researchers from UQ identified and validated exosomal protein and micro-RNA (miRNA) biomarkers that when combined in its OCRF-7 algorithm showed more than 90% accuracy to detect stages I and II ovarian cancer in an independent 500-sample retrospective case-control study, Inoviq CEO Leearne Hinch told BioWorld.
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Flag of Australia, sky background

Australia’s TGA meets legislated time frames for device, IVD reviews

April 18, 2022
By Tamra Sami
No Comments
In its first report on device application processing times since it completed most of its medical device reforms, Australia’s Therapeutic Goods Administration (TGA) met all the legislated time frames for processing medical device applications during the six-month period from July 31 to December 2021.
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Map of Australia as blue circuit board, digital network

Pfizer in bid to acquire digital health company Resapp for AU$100M

April 12, 2022
By Tamra Sami
No Comments
Pfizer Australia Holdings Pty Ltd. has made an offer to acquire digital health company Resapp Health Ltd. in all cash offer worth AU$100 million (US$74.25 million). The two companies have entered into a binding scheme that is contingent upon shareholder agreement and regulatory clearances in Australia. Shareholders will vote on the proposed acquisition in June, and directors have unanimously recommended that shareholders vote in favor of the acquisition.
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Map of Australia, vaccine vial and syringe

Australia to allow imports of overseas medicines to mitigate drug shortages

April 12, 2022
By Tamra Sami
No Comments
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods.
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Cancer research illustration

Telix in-licenses Lilly’s failed olaratumab in deal worth up to $225M

April 12, 2022
By Tamra Sami
No Comments
Telix Pharmaceuticals Ltd. has in-licensed Eli Lilly and Co.’s olaratumab antibody, agreeing to pay $5 million up front for exclusive worldwide rights to develop and commercialize radiolabeled forms of the antibody for the diagnosis and treatment of human cancers.
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Australia to allow imports of overseas medicines to mitigate drug shortages

April 6, 2022
By Tamra Sami
No Comments
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods.
Read More
Woman coughing

Resapp reports positive results for cough-based COVID-19 screening test for smartphones

March 22, 2022
By Tamra Sami
No Comments
Resapp Health Ltd. saw its stock shoot up 35% on the heels of positive clinical results for its new smartphone-based COVID-19 screening test. In a pilot clinical trial of 741 patients recruited in the U.S. and India, digital health company Resapp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, correctly detected COVID-19 in 92% of people with the infection.
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Paul Anderson

TGA clears Orthocell’s regenerative nerve repair device

March 21, 2022
By Tamra Sami
No Comments
Australia’s Therapeutics Goods Administration (TGA) cleared Orthocell Ltd.’s regenerative nerve repair device, Remplir, a biological scaffold that mimics the outer layer of the peripheral nerve to facilitate nerve repair.
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