AUSTRALASIA
TGA transparency reforms (part 2): Early publication of major innovator prescription medicine applications
In Part 1 of this series (available here), we examined the impact of the proposal by Australia’s Therapeutic Goods Administration (TGA) to provide early confidential notification to innovators of applications under evaluation...
In Part 1 of this series (available here), we examined the impact of the proposal by Australia’s Therapeutic Goods Administration (TGA) to...
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AUSTRALASIA
TGA transparency reforms (part 1): Notification of generic and biosimilar medicines to impact pharmaceutical patent disputes in Australia
Regulatory changes recently approved by the Australian Government are likely to impact the way in which pharmaceutical patent litigation is conducted in Australia. The Therapeutic Goods Administration (TGA) is...
Regulatory changes recently approved by the Australian Government are likely to impact the way in which pharmaceutical patent litigation...
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AUSTRALASIA
Diagnostic Testing for SARS-CoV-2: How governments, regulators and the laboratory-diagnostics industry are responding to the challenge
In this article we examine how standard polymerase chain reaction (PCR) based testing for the novel coronavirus (SARS-CoV-2) works, explore the new CRISPR-based tests under development and the new...
In this article we examine how standard polymerase chain reaction (PCR) based testing for the novel coronavirus (SARS-CoV-2) works,...
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AUSTRALASIA
COVID-19: mRNA vaccines – a promising approach to vaccine development
The urgent need to develop an effective vaccine to provide individuals and populations worldwide with immunity against the COVID-19 disease caused by the novel coronavirus, SARS-CoV-2, has led several...
The urgent need to develop an effective vaccine to provide individuals and populations worldwide with immunity against the COVID-19...
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AUSTRALASIA
Biosimilars in Australia
A ‘biosimilar medicine’ or ‘biosimilar’ is a highly similar, but not identical, version of an original biological medicine (‘reference medicine’) – a medicine comprised of large complex molecules derived...
A ‘biosimilar medicine’ or ‘biosimilar’ is a highly similar, but not identical, version of an original biological medicine (‘reference...
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AUSTRALASIA
“Promising” development for ESCO Corporation
ESCO Corporation v Ronneby Road Pty Ltd FCAFC 46 We previously reported the Federal Court decision in Ronneby Road Pty Ltd v ESCO Corporation  FCA 588  in which all claims...
ESCO Corporation v Ronneby Road Pty Ltd FCAFC 46 We previously reported the Federal Court decision in Ronneby Road Pty...
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AUSTRALASIA
Pfizer succeeds in Full Federal Court appeal and will now receive preliminary discovery regarding possible infringement of biological medicine process patents
We previously reported on the 21 March 2017 decision of Burley J of the Federal Court of Australia in Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd  FCA 285, in which...
We previously reported on the 21 March 2017 decision of Burley J of the Federal Court of Australia in Pfizer Ireland Pharmaceuticals...
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