PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is asking for industry feedback on whether Australia should change its naming mechanisms for biosimilars and biologics and if it should adopt practices of other international regulators.
PERTH, Australia – Melbourne-based biotech Starpharma Ltd. expects to file its rolling NDA with the FDA in the next month following positive phase III results for Vivagel BV for preventing recurrent bacterial vaginosis.
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is asking for industry feedback on whether Australia should change its naming mechanisms for biosimilars and biologics and if it should adopt practices of other international regulators.
PERTH, Australia – Patients in Australia will now be able to get unapproved drugs through their doctors more quickly since Australia amended its drug and device regulations earlier this year.
PERTH, Australia – Patients in Australia will now be able to get unapproved drugs through their doctors more quickly since Australia amended its drug and device regulations earlier this year.
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.
