PERTH, Australia – It's likely that Australia will not draft separate guidance or regulations for software applications that use artificial intelligence or machine learning (AI/ML) for drug development or medical devices.

PERTH, Australia – San Diego-based Okogen Inc. is taking its clinical trial program to Australia where it will test its lead compound OKG-0301 for acute adenoviral conjunctivitis in the phase II (RUBY) trial.

PERTH, Australia – San Diego-based Okogen Inc. is taking its clinical trial program to Australia where it will test its lead compound OKG-0301 for acute adenoviral conjunctivitis in the phase II (RUBY) trial.

PERTH, Australia – Following positive results across three different oncology clinical trial programs with its lead candidate, Veyonda, Sydney-based Noxopharm Pty Ltd. has secured a AU$26 million (US$18 million) funding facility from U.S. investors leading up to a proposed Nasdaq listing.

PERTH, Australia – Telix Pharmaceuticals Ltd. raised AU$40 million as it prepares regulatory packages and commercial strategies in Europe, the U.S. and Australia.

PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.