1-10 of 57 results
PE Horizons 2025: the year to get creative
Key PE trends from 2024 and what these mean for the Australian and global markets in 2025. ...
Patent term extensions under siege: a new era of challenges for pharmaceutical patentees
A recent Federal Court decision has struck down a patent term extension granted to Novartis for its blockbuster heart failure drug Entresto. The decision in Novartis AG v Pharmacor Pty Limited follows a recent trend of successful challenges by generic pharmaceutical companies. ...
Healthcare property - an emerging trend for investors
While investing in healthcare-related property is generally similar to investing in other classes of property, in this Insight we explain some key differences and risks that investors need to be aware of. ...
From Sleeping Giant to Awakening Giant – ANDHealth Report on the Australian Digital Health Sector
ANDHealth recently launched its detailed report on the state of the Australian digital health sector, The Awakening Giant: The Rise of Australia's Evidence-Based Digital Health Sector. In this Insight we summarise some of the key takeaways from the report, including key trends and challenges for the Australian market. ...
Aged care reform: back on the agenda
In this Insight, we focus in on the key regulatory enforcement and provider governance reforms to be implemented under the Royal Commission Response Bill and the implications for approved providers. ...
Software-based medical devices: key regulatory requirements, IP considerations and data privacy implications
Software is increasingly being used as a medical device and in medical devices. It is crucial that businesses understand the regulations that can apply to software-based medical devices, the IP considerations if they wish to protect such devices and the privacy-related risks associated with the collection and use of data from such devices. This Insight explores each of these issues in turn. ...
Antibody patent protection in Australia
Many of the top selling drugs in Australia are antibodies, all part of a global market estimated to reach US$140 billion this year. Recently, the US FDA (Food and Drug Administration) approved the fir ...
Expansion in scope of transactions subject to FIRB approval rules
In this Insight, we look at the changes and comment on what they mean for transactions. The changes to the SOCI Act also have operational implications for many businesses – which we will separately publish on. ...
3D printing – new rules for personalised medical devices
Australia's new regulations governing personalised medical devices, including 3D-printed devices, will have significant effects. They narrow the definition of custom-made medical devices, which will continue to be given regulatory exemptions but be subject to more regulatory requirements. ...
Repurposing existing medicines – industry to have its say in reshaping Australia's regulatory future
The Therapeutics Goods Administration (the TGA) is consulting with the public and industry to potentially reform regulatory and reimbursement frameworks, to incentivise the repurposing of existing medicines. Off-label use (where a medicine is used for a disease or medical condition for which it does ...