51-60 of 82 results
Assessment of biosimilars - Is Australia leading, following or going its own way?
The ongoing lack of certainty about what is required to obtain biosimilar registration in Australia extends to three key issues - Comparability is the new product sufficiently similar to permit it to rely on the reference products safety and efficacy data Extrapolation for which of the indications ...
Costs before Caution - Australia's unique approach to the interchangeability of biosimilars
Recent developments in Australia suggest that there has been a deliberate prioritisation of the cost benefits of facilitating biosimilar interchangeability over the safety and efficacy risks that can arise when biosimilars are used interchangeably ...
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. ...
Corporate culture an increasing legal and reputational risk
Significantly, the report's findings move beyond broad recommendations, identifying the key factors singled out by the law and regulators as drivers of corporate culture and naming general counsel, ...
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 ...
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 ...
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 ...
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 ...
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 ...
Special Report: Understanding the opportunities and navigating the legal frameworks of distributed ledger technology and blockchain
Authored by a multidisciplinary team from Allens Blockchain Reaction is designed to assist business stakeholders decision makers and in-house counsel across a variety of sectors to understand the technology and how it is being used as well as navigate the regulatory and legal opportunities and ...