461-470 of 554 results
ASIC announces fintech licensing exemptions
As part of its implementation of the regulatory sandbox for fintech companies ASIC is providing relief for certain fintech businesses from the obligation to hold an Australian financial services or Australian credit licence Relief may be available for up to 12 months and may be useful to businesses ...
Predictive coding gets green light from an Australian court
The Victorian Supreme Court recently handed down the first decision of an Australian court to specifically consider and approve the use of predictive coding technology in a large-scale discovery exercise Partner Nick Rudge Managing Associate Kate Austin and Applied Legal Technology Manager Lisa ...
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 ...
Worth the wait? Release of draft mandatory data breach notification laws
Following a period of industry consultation the Federal Government has introduced updated legislation that will introduce a mandatory data breach notification scheme The new Bill will amend the Privacy Act 1988 Cth when it comes into force and will apply to all Australian companies currently subject ...
E-signature - a case study, but not a test case
A recent New South Wales Court of Appeal decision concerned a guarantee purportedly signed by e-signature without the guarantors knowledge It is an interesting case-study though the decision is really about ostensible authority and ratification Senior Finance Counsel Diccon Loxton considers its ...
Protecting investment in biologic medicines - biological medicines, biosimilars and the challenges they pose
This series of articles is directed towards the part of biotech that is pharmaceutical rather than diagnostic or bioengineering technologies and in particular towards biologic medicines ...
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 ...
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. ...
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 ...