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.
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.
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.
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.
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.
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.
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.
Given the challenges in repurposing medicines, Australia’s Therapeutics Goods Administration (TGA) opened a second consultation on the subject March 10.
Singular Health Group Ltd. entered a 50-50 joint venture in Macau that will explore the potential of Singular’s Scan to Surgery software for the East Asian market, which the company has long seen as a key opportunity for its 3D software and medical 3D printing ambitions.
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