Australia’s Therapeutic Goods Administration (TGA) is proposing that devices be subject to good clinical practices (GCP) inspections, and it is proposing two approaches to achieve that goal.
The University of Sydney is investing AU$478 million (US$326.5 million) to build a leading biomedical precinct to fast-track research and shorten the time between discovery and development of transformative therapies.
Australian radiopharmaceutical company Advancell Co. Ltd. closed an AU$18 million (US$12.4 million) series B round that will take its lead targeted alpha-emitting radiotherapy, ADVC-001, for metastatic prostate cancer to the clinic by the end of 2022.
Women with endometriosis may soon be able to take a simple blood test to determine if they have the condition thanks to a new test being developed by Proteomics International Pty Ltd. that detects up to 78% of women with endometriosis.
Western Australia’s private investment group Tattarang has launched a new AU$250 million (US$173.6 million) investment fund called Tenmile that will invest in early stage Australian biotech and med-tech companies. One of Australia’s largest private investment groups, Tattarang is owned by the Forrest family and has five business divisions made up of real estate, agriculture, energy, mining and hospitality.
Regenerative medicine company Avita Medical Ltd. reported that topline results were mixed for its pivotal trial evaluating the safety and effectiveness of its Recell system combined with meshed autograft for reducing donor skin harvesting in soft tissue reconstructions.
Western Australia’s private investment group Tattarang has launched a new AU$250 million (US$173.6 million) investment fund called Tenmile that will invest in early stage Australian biotech and med-tech companies. One of Australia’s largest private investment groups, Tattarang is owned by the Forrest family and has five business divisions made up of real estate, agriculture, energy, mining and hospitality.
Paradigm Biopharmaceuticals Ltd. announced a AU$66 million (US$46.39 million) capital raise to fund its phase III pivotal trial for injectable Zilosul (pentosan polysulfate) to treat osteoarthritis of the knee.
The FDA granted Adherium Ltd. 510(k) clearance for its next-generation Hailie sensor that connects with Glaxosmithkline plc’s Ellipta inhaler to enable monitoring of medication use for asthma and chronic obstructive pulmonary disorder (COPD).
Stem cell therapy company Mesoblast Ltd. said that for patients with chronic heart failure with reduced ejection fraction, treatment with rexlemestrocel-L, its allogeneic product candidate, resulted in greater improvement in a prespecified analysis of left ventricular ejection fraction at 12 months relative to controls in the phase III DREAM-HF trial.
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