21-30 of 40 results

Directors' duties and cyber resilience
Insight 05 Sep 2017

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 ...

OAIC concludes investigation of Australian Red Cross data breach
Insight 05 Sep 2017

A one-off human error by a third party provider's employee led to a massive data breach that hit the Australian Red Cross Blood Service late last year. Nearly a year after the breach, the Australian Information and Privacy Commissioner, Timothy Pilgrim, has concluded his investigation.  ...

ACCC's Enforcement and Compliance priorities for 2017
Insight 27 Feb 2017

Criminal cartels unfair contract terms consumer guarantees and the health construction and agriculture sectors are some of the ACCCs key enforcement and compliance priorities for 2017 ACCC Chairman Rod Sims released the ACCCs 2017 Compliance and Enforcement Policy on Friday 24 February 2017 ...

Assessment of biosimilars - Is Australia leading, following or going its own way?
Insight 26 Oct 2016

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 ...

Protecting investment in biologic medicines - biological medicines, biosimilars and the challenges they pose
Insight 15 Sep 2016

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?
Insight 08 Sep 2016

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
Insight 17 Aug 2016

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 ...

Discussion Paper: Biologic medicines and biosimilars in the Australian landscape - The challenges and the opportunities
Insight 01 Aug 2016

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 ...

Protecting innovation without patents - data exclusivity and market exclusivity
Insight 19 Jul 2016

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 ...

Special Report: Understanding the opportunities and navigating the legal frameworks of distributed ledger technology and blockchain
Insight 17 Jun 2016

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 ...