Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
A new analysis of Actinogen Medical Ltd.’s phase II Xanadu trial showed that in biomarker-positive patients with mild Alzheimer’s disease there was a clear clinical effect with lead compound Xanamem not seen in the earlier trial.
A review of Australia’s National Medicines Policy was begun in August 2021 but was paused until after the federal election in May to allow stakeholders more time to provide feedback.
A review of Australia’s National Medicines Policy was begun in August 2021 but was paused until after the federal election in May to allow stakeholders more time to provide feedback.
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. has had its hopes of entering the U.S. market dashed yet again following a second decision from the FDA that Febridx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application.
Immuno-oncology company Imugene Ltd. announced an AU$80 million (US$53.9 million) capital raise that will allow the company to add additional studies within its immuno-oncology pipeline as well as pursue potential licensing opportunities. The funds raised will allow the company to interrogate its pipeline further in other indications or combinations, Imugene CEO Leslie Chong told BioWorld. “There’s a lot we could do with our current pipeline, and now our cashflow is greatly extended.”
Scientists from the University of Queensland have created a new antibiotic that can neutralize various gram-positive bacteria in mice, including major threats such as methicillin-resistant Staphylococcus aureus (MRSA). In a recent study, published in the Sept. 14, 2022, issue of Science Translational Medicine, the new compound outperformed the approved antibiotic vancomycin, and destroyed tough-to-eradicate bacterial biofilms while prompting a low rate of resistance.
Immuno-oncology company Imugene Ltd. announced an AU$80 million (US$53.9 million) capital raise that will allow the company to add additional studies within its immuno-oncology pipeline as well as pursue potential licensing opportunities. The funds raised will allow the company to interrogate its pipeline further in other indications or combinations, Imugene CEO Leslie Chong told BioWorld. “There’s a lot we could do with our current pipeline, and now our cashflow is greatly extended.”
Pharmaxis Ltd. has found new funding to breathe life into a drug that looked like it might sit on the shelf for a while, but now appears to be a good candidate for tackling Parkinson’s and other neurodegenerative diseases.
Melbourne-based Occurx Pty Ltd. announced a AU$16 million (US$11 million) series B round that will progress lead candidate OCX-063 to phase II trials in chronic kidney disease. The capital raise was jointly led by Brandon Biocatalyst and Uniseed and includes a AU$1.5 million grant from Australian biomedical incubator Cureator.