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.
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 – Sydney-based Imugene Ltd.’s stock shot up 15% on news that an interim analysis of phase II data in its B-cell peptide vaccine, HER-Vaxx, in advanced gastric cancer showed positive survival data, and the data monitoring committee said it could lower the number of patients required for study completion.
PERTH, Australia – Immutep Ltd. completed a AU$29.6 million (US$21.72 million) placement that will allow the immunotherapy company to accelerate and broaden clinical development of its immuno-oncology and autoimmune programs.
PERTH, Australia – Sydney-based Imugene Ltd.’s stock shot up 15% on news that an interim analysis of phase II data in its B-cell peptide vaccine, HER-Vaxx, in advanced gastric cancer showed positive survival data.
PERTH, Australia – It was already going to be a busy year for Australia’s Therapeutic Goods Administration (TGA) as it planned to implement the final wave of device reforms in 2020 before the COVID-19 pandemic hit. The delay to the EU Medical Device Regulation (MDR) as a result of the pandemic will mean that Australia will also push back many of its device reforms for another year, said John Skerritt, the TGA’s deputy secretary of the Health Products Regulation Group.
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.