481-490 of 665 results
The High Court has its say on penalties
The high court handed down its decision in Paciocco v Australia and New Zealand banking group limited. ...
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 ...
ATO rules on Bitcoin - not enough purchase to be money
The Australian Tax Office has released draft rulings stating their view that the digital currency Bitcoin is property and not money Partner Gavin Smith Associate David Rountree and Associate Tom Tian consider the potential consequences for Australian businesses using Bitcoin ...
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 ...
Fact sheet: Starting-up smart: How to get the most out of your lawyer, for less
If youre focused on testing your idea developing your product and scraping together enough funds to talk to foundation customers engaging a lawyer could be the last thing on your mind ...
APRA information paper targets shared computing arrangements
In response to its concerns about the potential risks associated with shared computing services including cloud computing APRA has issued an information paper that sets out prudential considerations and key principles for APRA-regulated entities using such services Partner Michael Morris Senior ...
Fact sheet: The term sheet decoded
The term sheet is the key document that determines the basis on which VCs and other investors will invest in your startup This means that its crucial to get the basics right from the outset ...
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 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 ...