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 rapid point-of-care tests being rolled out, and consider the initiatives by governments and medical device regulators to fast-track the availability of SARS-CoV-2 diagnostic tests.   Diagnostic

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 in some way from a living organism.  In this sense, a biosimilar differs to some extent from a traditional small molecule “generic” medicine, which is commonly

Federal Court brings generic manufacturers a step closer to a large damages payment re Escitalopram

The Federal Court of Australia has dismissed an appeal by Alphapharm and others against the Commissioner of Patents’ decision to allow a patent term extension on Lundbeck’s patent covering the antidepressant drug Escitalopram (LEXAPRO) (the Escitalopram Patent) – Alphapharm Pty Ltd v H Lundbeck A/S [2014] FCA 1185. This decision immediately followed the High Court’s