Pharmabcine Inc. has received approval from the human research ethics committee (HREC) in Australia for a phase Ia/b trial of PMC-309, a monoclonal antibody against the human V-domain Ig suppressor of T-cell activation (VISTA) ligand.
A fluorescent imaging agent developed by Vergent Bioscience Inc. enables visualization of elusive and previously undetected tumors, a phase II study presented last week at the 2023 World Conference on Lung Cancer (WCL23) demonstrated. The ability of the tumor-targeting agent, Vgt-309, to illuminate tumors could help surgeons more precisely locate tumors, better ensure clean margins and guide care decisions. In 10% of cases, the agent revealed unknown tumors in lymph nodes, which could affect which nodes are biopsied as well as when or whether a systemic therapy is recommended.
Australia’s Therapeutic Goods Administration (TGA) posted a Sept. 6 hazard alert for the Scandinavian Total Ankle Replacement (STAR) device by DJO Global, a subsidiary of Wilmington, Del.-based Enovis Corp. TGA said the polyethylene insert used to eliminate friction between the device’s moving parts has demonstrated a higher-than-expected fracture rate, and that the device has been delisted from the Australian Register of Therapeutic Goods (ARTg).
Gain Therapeutics Inc. has received human research ethics committee (HREC) approval in Australia to initiate a phase I study of its lead drug candidate GT-02287 in development for GBA1-Parkinson’s disease. The study is expected to begin in the near term.
Wearoptimo Pty. Ltd. saw the publication of a patent application for its method and system for analyzing measurements from a wearable patch with sensors connected to microstructures that when applied to the skin penetrate the stratum corneum and enter the viable epidermis.
People who can’t verbalize their pain often end up being under medicated, and Painchek Ltd. uses artificial intelligence (AI) to identify the presence of pain even when it may not be obvious. This gives a voice to those who cannot verbalize pain, while also driving objectivity and consistency in pain assessments.
A woman in Nambour, Australia, is the first patient to receive a minimally invasive implantable neuromodulation device for severe migraine and cluster headache in a first-in-human study conducted by Salvia Bioelectronics BV.
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.
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.
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.
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