PERTH, Australia – Melbourne, Australia-based Opthea Ltd. announced positive phase IIb results demonstrating that OPT-302 combination therapy met the primary endpoint of superiority in mean visual acuity gain at 24 weeks compared to Lucentis (ranibizumab, Roche Holding AG/Novartis AG) monotherapy in treatment-naïve patients with wet age-related macular degeneration (AMD).
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.
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 – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.
PERTH, Australia – Australian immuno-oncology company Imugene Ltd. signed a deal to in-license an oncolytic virus known as CF33 from the City of Hope Comprehensive Cancer Center in Los Angeles, in a move to bolster its pipeline and open up a new area of growth for the company, said CEO Leslie Chong.
