SK Bioscience Co. Ltd. and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid.
Opthea Ltd. plans to raise AU$80 million (US$51.2 million) via a AU$10 million private placement and a AU$70 million entitlement offer to continue its pivotal phase III trials in wet age-related macular degeneration (wet AMD) for lead candidate OPT-302.
Curvebeam AI Ltd. made its debut on the Australian Securities Exchange (ASX:CVB) after raising AU$25 million (US$16.175 million) in an initial public offering that will allow the company to market its flagship Hirise weight-bearing CT scan solution globally.
Imagion Biosystems Ltd. signed a flurry of deals recently to expand its pioneering molecular magnetic resonance imaging platform Magsense beyond Australia and into additional indications to detect cancer earlier.
Incannex Healthcare Ltd. is gearing up to begin a pivotal phase II/III trial in the U.S. for its lead asset, IHL-42X (dronabinol/acetazolamide), a synthetic cannabinoid combination drug for sleep apnea.
Imagion Biosystems Ltd. signed a flurry of deals recently to expand its pioneering molecular magnetic resonance imaging platform Magsense beyond Australia and into additional indications to detect cancer earlier.
Adalta Ltd. is gearing up to begin phase II trials of its lead i-body candidate, AD-214, in idiopathic pulmonary fibrosis (IPF), but it is hoping to find a pharma partner to fund the trials.
Australia’s Therapeutic Goods Administration (TGA) has issued a regulatory proposal regarding the agency’s approach to audits for devices, a proposal that might reduce the number of these audits. TGA said it may limit audits to the highest-risk devices and may eliminate them for devices that have been granted market access in other regulatory jurisdictions.
The HIV journey is a roller coaster of highs and lows for the patients living with HIV and their families and loved ones but also for the community of researchers and clinicians who pour their hearts and souls into the work they do, said speakers at the International AIDS Society (IAS) 2023 conference in Brisbane, Australia.
Australia’s Therapeutic Goods Administration (TGA) is reconsidering its approach to regulating devices that bear materials of animal, microbial or recombinant origin, a broad class of products that includes transcatheter aortic valve replacement (TAVR) devices.