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The Albanese Government’s Economic Reform Roundtable has generated a cascade of proposals from across departments and agencies about how to lift productivity and improve regulatory efficiency.

The US FDA has unveiled a significant regulatory advance with the introduction of its Rare Disease Evidence Principles, the latest example of a growing global momentum to accelerate the development and approval of therapies targeting rare diseases.

Mayne Pharma has moved to reassure staff and investors after media reports suggested its Salisbury manufacturing site in South Australia could be at risk of closure if its proposed merger with US company Cosette Pharmaceuticals goes ahead.

Alterity Therapeutics (ASX:ATH) has secured $20 million in new funding to accelerate the development of its lead drug candidate ATH434, a potential disease-modifying therapy for multiple system atrophy (MSA), a rare and devastating neurodegenerative disorder.

Regenerative medicine company Orthocell (ASX:OCC) has reported promising interim results from its ongoing Remplir Real-World Evidence study, reinforcing the performance of its collagen nerve wrap in routine clinical practice and laying the groundwork for international expansion.

Proteomics International Laboratories (ASX:PIQ) has unveiled new clinical results that could transform the early detection landscape for esophageal adenocarcinoma (EAC), a deadly cancer that has long eluded timely diagnosis.

The documents produced by the HTA Review over nearly three years suggest refined language on comparator selection to clarify the status quo and a reduced discount rate for only some gene therapies and vaccines.

Health department Secretary Blair Comley PSM has argued that digitalisation and AI will be pivotal in reshaping how Australians access medicines, treatments, and health services.

Professor Edward Holmes, National Health and Medical Research Council Leadership Fellow and Professor of Virology at the University of Sydney, has been awarded the 2025 GSK Award for Research Excellence.

If AI can genuinely improve HTA processes, then the government should be able to quantify that as a goal, in terms of days. If the TGA can deliver a 70-day improvement, surely HTA advisory committees can promise at least the same?

AVITA Medical (ASX:AVH) has reinforced the economic case for its RECELL System after new real-world data showed the technology can cut hospital stays for burn patients by more than a third, potentially unlocking significant savings for US healthcare providers.

Botanix Pharmaceuticals (ASX:BOT) has welcomed news that its partner Dongwha Pharm has secured regulatory approval for ECCLOCK gel, 5% (sofpironium bromide) in South Korea, paving the way for the product’s commercial launch in the first quarter of 2026.