Alterity Therapeutics Ltd. reported positive top-line phase II results for lead candidate ATH-434 for treating multiple system atrophy, a rare neurological disorder similar to Parkinson's disease.

George Medicines, a new spinout from Australia’s George Institute for Global Health, could offer patients better control of their blood pressure as well as fewer side effects thanks to an ultra-low-dose triple combination.

Aussie radiopharma company Advancell Co. Ltd. closed an oversubscribed $112 million series C round that will accelerate clinical development of its pipeline of radionuclide therapies and allow it to expand its manufacturing capacity.

Vaxxas Pty. Ltd. and the Coalition for Epidemic Preparedness Innovations are progressing heat-stable, dried-formulation mRNA vaccines using Vaxxas’ needle-free high-density microarray patch.

South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.

The Chinese government blacklisted several American companies, including gene sequencing-focused biotechnology firm Illumina Inc. and fashion brand PVH Corp., citing threats to China’s “national sovereignty, security and development interests.”

To realize the promise of cell therapy for neurodegenerative disorders, S.Biomedics Co. Ltd. is looking to expand clinical trials of TED-A9, its stem cell therapy for Parkinson’s disease (PD), to the U.S., having reaped positive results from a domestic phase I/IIa trial in November 2024.

Japan’s drug pricing scheme has gotten more complicated, and pharma companies should brace themselves for annual price cuts. Industry has been pushing back against the annual price reductions to no avail, Ray Fujii, managing director of LEK’s San Francisco office told BioWorld. Although 2025 is a mid-year revision in Japan, and not a formal price revision year, the system for considering drug prices has gotten more confusing with a new formula for determining price cuts.

President Donald Trump’s penchant for tariffs as a negotiating tool was on full display when he slapped a 25% tariff on products coming from Mexico and Canada – which may already been suspended in the case of Mexico. The actual impact of the tariffs on med tech is nonetheless tough to gauge due in no small part to the prospect that manufacturers will simply pass on at least part of the tariff to its customers in the U.S.

Harmonized regulations for laboratory-developed tests (LDTs) across Asia Pacific are sorely needed at a time when LDTs continue to play a critical role in addressing unmet needs in the region, according to a recent whitepaper developed by APACMed.