PERTH, Australia – Melbourne-based Medicines Development for Global Health (MDGH) became the first not for profit company to register a drug through the FDA's tropical disease priority review program.
PERTH, Australia – Sydney-based Immutep Ltd. unveiled new data for its phase I immunotherapy study that showed a long-lasting and durable response and an overall response rate of 61 percent in a melanoma study combining its lead immunotherapy with Merck's anti-PD-1 therapy Keytruda (pembrolizumab).
PERTH, Australia – Sydney-based Immutep Ltd. unveiled new data for its phase I immunotherapy study that showed a long-lasting and durable response and an overall response rate of 61 percent in a melanoma study combining its lead immunotherapy with Merck's anti-PD-1 therapy Keytruda (pembrolizumab).
PERTH, Australia – In response to industry comments, Australia's Therapeutic Goods Administration (TGA) is getting ready to implement a new fee structure for drug GMP inspections.
PERTH, Australia – Sydney-based Minomic International Ltd.'s Micheck prostate cancer diagnostic was more than twice as specific in screening for prostate cancer than the standard of care prostate specific antigen (PSA) screening technology, a recent clinical trial showed. The Micheck diagnostic met both primary endpoints in a U.S. multicenter trial in 384 patients. The trial was a prospective, non-randomized case-control study, with a primary endpoint of detecting prostate cancer versus no cancer, and a secondary endpoint of differentiating between aggressive and non-aggressive cancer.
