51-60 of 79 results
TGA confirms its approach to disclosure of commercially confidential information
The Therapeutic Goods Administration has released the final version of a document outlining its approach to the disclosure of commercially confidential information including information provided by medicine sponsors This follows the release of a draft version in June 2013 and a period of public and ...
Allens insights: Implementation of Australia's PCEHR system reviewed
At the end of 2013 the Federal Minister for Health announced a panel review into Australias Personally Controlled Electronic Health Record PCEHR system to consider implementation and uptake issues The subsequent report made public in May 2014 puts forward 38 recommendations to address the issues ...
Isolated genetic material confirmed as patentable
In a unanimous decision the Full Federal Court has confirmed that genetic materials in their isolated form remain patentable in Australia The decision related to an appeal from an earlier Federal Court decision in which it was found isolated nucleic acids to be a manner of manufacture as required by ...
Audio: D'Arcy v Myriad: The High Court rules on gene patenting
Allens Partner Dr Trevor Davies discusses why the High Court overturned the decision and what it means for the biotech industry ...
Discussion Paper: Biologic medicines and biosimilars in the Australian landscape - The challenges and the opportunities
Allens is engaging with stakeholders on the challenges and opportunities presented by biosimilars As part of this engagement we highlight a number of key issues for discussion and comment ...
Allens advises EBOS Group on acquisition of HPS
Allens has advised EBOS Group Limited on the proposed purchase of HPS, Australia's largest provider of outsourced pharmacy services. The acquisition of HPS - from Blue Sky Private Equity and a numb ...
Ambush marketing: traders beware!
Everyone knows the famous adage that 'the enemy of my enemy is my friend'. But can the friend of my friend be my enemy? In the context of ambush marketing, the answer can be yes. ...
Directors' duties and cyber resilience
The Target data breach brought the liability of boards and directors in relation to cyber resilience into focus. Target's shareholders brought litigation against all of its directors, the chief financial officer and the chief information officer due to what was perceived as recklessness and disregar ...
Unexpected risks of the IoT revolution: Cyber security in medical devices
In late August 2017 the US Food and Drug Administration recalled 465000 Abbott Laboratories pacemakers due to cyber security vulnerabilities Although this was the first time that the FDA had recalled a medical device because of cyber concerns they have been alive to the significant risk that a cyber ...
Allens advises Clearskincare on $127.4m acquisition
Allens has advised the founders of Clearskincare on the sale of the brand's clinic and products businesses to Australian Pharmaceutical Industries (API) for $127.4 million. Under the deal, API will ...