New TGA guidance on the regulation of AI-based software medical devices
17 February 2026
Opportunities for the application of AI in health and life sciences continue to grow.
Read on
Healthcare & pharmaceuticals
Australia reformulates its position on patent term extensions
15 December 2025
The Full Federal Court of Australia has determined that pharmaceutical formulations are not eligible for patent term extension in Australia.
Read on
A new code for care: decoding the impact of Genomics Australia
19 August 2025
The Australian health sector is entering a transformative phase with the official launch of Genomics Australia on 1 July 2025 and a new Australian Health Genomics Commissioner.
Read on
It’s alive — and growing! Updates from the TGA’s 2025 AI review
5 August 2025
The rapid evolution of artificial intelligence and the expansion of the use of software in the delivery of healthcare is transforming the medtech landscape, offering unprecedented opportunities for innovation in patient care.
Read on
Branched meanings: Lexicography of ‘branched alkyl’ decides Moderna’s COVID-19 vaccine patent dispute
1 July 2025
The United States Court of Appeals for the Federal Circuit (CAFC) recently decided that Moderna’s mRNA-based COVID-19 vaccine, SPIKEVAX®, did not infringe Alnylam’s patents because the cationic lipid used in the vaccine, SM-102, was not a cationic lipid with a ‘branched alkyl’ group.[1] The case turned on the proper construction of ‘branched alkyl’.
Read on
The digital doctor will see you now: AI large language models expanding telehealth offerings
26 June 2025
In a country as geographically vast as Australia, providing high quality health care can be difficult to provide cost effectively.
Read on
Gene-ius at stake: who really cracked CRISPR in plants and animals?
3 June 2025
Many of our readers will have first heard of CRISPR-Cas9 a number of years ago.
Read on
Regulatory spotlight on telehealth
3 June 2025
Health Minister Mark Butler has requested that the Therapeutic Goods Administration consider ‘options to improve standards of telehealth’ in online prescribing.
Read on
A new prescription for prescribing? AHPRA’s prescription framework gets a health check
3 April 2025
The Australian Health Practitioner Regulation Agency (AHPRA) is currently undertaking a comprehensive review of the second edition of the Prescribing Competencies Framework — Embedding quality use of medicines into practice (the Framework) that outlines the competencies and expectations for safe and effective prescribing.
Read on