PERTH, Australia – Dimerix Ltd. reported positive phase IIa data with its lead program, DMX-200, in chronic kidney disease. The dose-escalation trial met the primary endpoints of safety and tolerability, and it met secondary efficacy endpoints with 25 percent of patients achieving a greater than 50 percent reduction in proteinuria, which is over and above the standard of care, CEO Kathy Harrison told investors during a conference call last Thursday.
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) will start accepting priority review applications, and it has expanded its orphan drug designation criteria, thanks to new legislation passed last month that overhauls the country's drug regulations.
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) will start accepting priority review applications, and it has expanded its orphan drug designation criteria, thanks to new legislation passed earlier this month that overhauls the country's drug regulations.