PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Astrazeneca Pty Ltd. for its COVID-19 vaccine, a recombinant adenovirus vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia, following the Jan. 26 provisional approval for Pfizer Australia Pty Ltd.’s COVID-19 vaccine, branded Comirnaty.
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.
PERTH, Australia – After hitting a few setbacks in recent months, regenerative medicine company Mesoblast Ltd. believes it finally has a path to market with its allogeneic mesenchymal precursor cell therapy, rexlemestrocel-L, in chronic low back pain.
PERTH, Australia – Synthetic cannabinoid company Botanix Pharmaceuticals Ltd. announced top-line data from a phase IIa study showing that two different formulations of BTX-1801, a synthetic cannabidiol (CBD), eradicated Staphylococcus aureus (staph) in the nose, meeting study endpoints for safety and efficacy.
PERTH, Australia – Wellington, New Zealand-headquartered Volpara Health Technologies Ltd. has acquired Boston-based CRA Health LLC for $18 million up front and an additional $4 million to be paid over the next 18 months in earnouts. Volpara’s digital health solutions use imaging and artificial intelligence (AI) for early detection of breast cancer. The company’s clinical functions for screening clinics provide feedback on breast density, compression, dose, and quality, while its enterprise-wide practice software management helps with productivity, compliance, reimbursement and patient tracking.
PERTH, Australia – Synthetic cannabinoid company Botanix Pharmaceuticals Ltd. announced top-line data from a phase IIa study showing that two different formulations of BTX-1801, a synthetic cannabidiol, eradicated Staphylococcus aureus (staph) in the nose, meeting study endpoints for safety and efficacy.
PERTH, Australia – Micro-X Ltd. completed an AU$30.5 million (US$23.27 million) placement to expand its U.S. footprint for its lightweight digital mobile X-ray systems. The funds raised will drive market expansion of Adelaide, Australia-based Micro-X’s Rover digital mobile X-ray system that is designed for deployed military medical facilities, and to scale up its Carestream DRX Revolution Nano, a mobile lightweight digital X-ray system for hospitals.
PERTH, Australia –Digital diagnostics company Ellume Ltd. announced a US$231.8 million agreement with the U.S. Department of Defense (DoD), in coordination with the Department of Health and Human Services (HHS), to accelerate domestic U.S. production of its COVID-19 home tests. The agreement includes funding to support the establishment of Ellume’s U.S.-based manufacturing facility and the delivery of 8.5 million COVID-19 home tests that will be distributed across the U.S.
PERTH, Australia – Sydney-based Immutep Ltd. announced that Glaxosmithkline plc is discontinuing a phase II ulcerative colitis trial of its anti-lymphocyte activation gene-3 cell-depleting monoclonal antibody, derived from Immutep’s IMP-731 antibody that GSK licensed in 2010.
