51-60 of 77 results
What's in a (biosimilar) name?
Because biosimilars and their reference biologic medicine are not identical whether compared to each other or even between biosimilars it is important to know which product has been used ...
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 ...
What you need to know about mandatory data breach notification
In response to the rising number of cyberattacks, new legislation has been introduced that proposes a mandatory notification regime that will take effect from February next year. ...
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 ...
High Court unanimously finds isolated genetic material not patentable
In the culmination of a hard-fought patent dispute the High Court of Australia has unanimously ruled that Myriad Genetics patent claims to isolated nucleic acid coding for the mutant or polymorphic BRCA1 polypeptide are not valid ...
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 ...
Protecting innovation without patents - data exclusivity and market exclusivity
Developments in patent law and the consequential limitations on patentability for biologic medicines mean that data exclusivity and market exclusivity can be the primary protection afforded to originator biologic medicines This is most stark in the US where patent protection for biologic medicines ...
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 advises Healthscope on sale of medical centres business
Allens has advised Healthscope Limited, one of Australia's leading private healthcare operators, on the sale of its Australian medical centres business to Fullerton Health, a leading provider of ...
Allens advises on Australian-first dementia village
Allens has provided pro bono advice to Social Ventures Australia on the financing of the ground-breaking Korongee dementia care village. The first of its kind in Australia, the village is designed ...