PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
PERTH, Australia – As the idea of going to Mars starts to look less far-fetched, scientists are beginning to ask practical questions about how space affects the stability of drugs.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HQO recommends home UVB therapy; Health Canada announces testing advisory panel.
PERTH, Australia – The COVID-19 pandemic has highlighted the importance of digital health technology, and the Australian government quickly enabled programs in telehealth and e-prescriptions. It now is embracing opportunities to build on this momentum to accelerate the country’s economic digital transformation. Not only will this transformation contribute to Australia’s recovery, but also to its long-term prosperity, said Sue MacLeman, chair of Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre (MTPConnect), during a recent ANDHealth teleconference.
PERTH, Australia – Gbs Inc. reported filing an initial public offering on the Nasdaq for $20 million, as the company looks to launch the first noninvasive SARS-Cov-2 test. A subsidiary of Sydney-based The Iq Group Ltd. (NSX:IQG), Delaware-based Gbs has developed a biosensor platform that enables real-time diagnostic point-of-care (POC) tests, and the funds raised will enable the company to launch its SARS- CoV-2 test and a saliva glucose test.
PERTH, Australia – Clinuvel Pharmaceuticals Ltd. announced two new pharmaceutical indications for its lead product, Scenesse (afamelanotide). “The company has until now focused on one drug and has slowly gathered evidence and is now in a position to add other products to its pipeline,” Clinuvel CEO Philippe Wolgen told BioWorld.
PERTH, Australia – Opthea Ltd. completed a $128.2 million IPO on the U.S. Nasdaq market, which will fund two phase III trials in wet age-related macular degeneration (AMD) and bring the company’s lead candidate, OPT-302, to market if successful.
PERTH, Australia – Clinuvel Pharmaceuticals Ltd. announced two new pharmaceutical indications for its lead product, Scenesse (afamelanotide). “The company has until now focused on one drug and has slowly gathered evidence and is now in a position to add other products to its pipeline,” Clinuvel CEO Philippe Wolgen told BioWorld.
PERTH, Australia – Opthea Ltd. completed a $128.2 million IPO on the U.S. Nasdaq market, which will fund two phase III trials in wet age-related macular degeneration (AMD) and bring the company’s lead candidate, OPT-302, to market if successful.
PERTH, Australia – Azura Ophthalmics Ltd. raised a $20 million series C round with existing investors, including Brandon Capital’s Medical Research Commercialization Fund (MRCF), Orbimed, TPG Biotech and Ganot Capital.