PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure.
PERTH, Australia – Although Australians pay less for their drugs than patients in many other countries, Australia is falling behind when it comes to reimbursement for newer, targeted therapies, according to a report launched by Medicines Australia that assessed the timelines for registration and reimbursement of new medicines in Australia compared to 10 other Organisation for Economic Co-operation and Development (OECD) countries.
PERTH, Australia – Chimeric Therapeutics Ltd. closed an IPO on the Australian Securities Exchange (ASX:CHM), raising AU$35 million (US$26.5 million) to fund its CAR T trial in glioblastoma.
PERTH, Australia – The University of Queensland (UQ) and CSL Ltd. are abandoning their trials of an Australian COVID-19 vaccine after recipients generated HIV antibodies during phase I trials. The response means the antibodies produced by the vaccine can interfere with HIV diagnostic tests. However, there was no possibility the vaccine caused infection, and routine follow-up tests confirmed no HIV virus was present, the partners said.
PERTH, Australia – As the idea of going to Mars starts to look less far-fetched, scientists are beginning to ask practical questions about how space affects the stability of drugs.
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
PERTH, Australia – Sydney-based Imugene Ltd.’s stock shot up 15% on news that an interim analysis of phase II data in its B-cell peptide vaccine, HER-Vaxx, in advanced gastric cancer showed positive survival data, and the data monitoring committee said it could lower the number of patients required for study completion.
PERTH, Australia – Immutep Ltd. completed a AU$29.6 million (US$21.72 million) placement that will allow the immunotherapy company to accelerate and broaden clinical development of its immuno-oncology and autoimmune programs.
PERTH, Australia – Clinuvel Pharmaceuticals Ltd. announced two new pharmaceutical indications for its lead product, Scenesse (afamelanotide). “The company has until now focused on one drug and has slowly gathered evidence and is now in a position to add other products to its pipeline,” Clinuvel CEO Philippe Wolgen told BioWorld.
PERTH, Australia – Opthea Ltd. completed a $128.2 million IPO on the U.S. Nasdaq market, which will fund two phase III trials in wet age-related macular degeneration (AMD) and bring the company’s lead candidate, OPT-302, to market if successful.