11-20 of 79 results
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. ...
Allens recognised for Deal of the Year and PPP of the Year at global awards
Lead partner for both projects David Donnelly acknowledged the teams behind the deals and commended their outstanding work during the uncertainty of the pandemic: 'We're delighted to be recognised ...
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. ...
Allens advises Healthe Care on sale of surgical business to PEP
Healthe Care's surgical hospitals portfolio comprises 12 hospitals and 7 day surgery centres in Australia and New Zealand, which together provide a diverse offering of healthcare services across ...
Allens advises Livingbridge on its acquisition of Everlight Radiology
Everlight provides teleradiology services for providers across the globe from its critical care hubs in the UK, Ireland, Australia and New Zealand. Everlight works with hospitals and clinics to ...
Allens advises Burnet Institute and management shareholders on the sale of 360biolabs
360biolabs is a Melbourne-based contract service organisation providing specialist expertise and laboratory services for the development of new therapeutics, vaccines and diagnostics. BioAgilytix ...
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 ...