PERTH, Australia – An independent review of recent reforms to Australia’s Therapeutic Goods Administration (TGA) advertising framework confirmed that the changes to the new advertising code resulted in improvement, with the new code being clearer and easier to understand. The advertising reforms are part of larger regulatory reforms implemented to increase the pathways for marketing approval for drugs and devices while reducing regulatory red tape and redundancies.

PERTH, Australia – As Victoria suffers through a second COVID-19 wave, bringing the death toll to 430 for Australia, Prime Minister Scott Morrison said that Australians could be among the first in the world to receive a COVID-19 vaccine through an agreement with Astrazeneca plc. Under the deal, every Australian would be able to receive AZD-1222, which is being developed with the University of Oxford.

PERTH, Australia – With 1 in 3 patients with type 2 diabetes likely to develop diabetic kidney disease (DKD), Perth-based Proteomics International Laboratories Ltd. has developed a blood-based diagnostic test that can predict the onset of DKD, enabling patients to get treatment sooner to prevent the onset of the disease.

PERTH, Australia – Patients with relapsed or refractory acute myeloid leukemia (r/r AML) who have received three or more lines of therapy are often too sick to get much-needed bone marrow transplants and often run out of options.

PERTH, Australia – Australian regenerative medicine company Mesoblast Ltd. saw its stock tumble more than 30% following the release of briefing documents from the FDA ahead of an Aug. 13 advisory committee meeting to review the company’s BLA for Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease (SR-aGVHD) in children.

PERTH, Australia – As the state of Victoria in Australia records its deadliest day since the COVID-19 pandemic began, reporting 17 deaths and 394 new cases, Atomo Diagnostics Ltd.’s new COVID-19 antibody test could ease pressure on health care systems.

PERTH, Australia – A review by Australia’s Therapeutic Goods Administration (TGA) revealed that medical device recall databases may significantly under-represent software errors, causing harm to patients. These under-reported events are due to patients being unaware how to report problems, inadequate information being reported, effects of software errors being too subtle or difficult to detect, or root cause analyses that may not identify software as the source of error when it causes other components to fail.

PERTH, Australia – Patients with relapsed or refractory acute myeloid leukemia (r/r AML) who have received three or more lines of therapy are often too sick to get much-needed bone marrow transplants and often run out of options. Melbourne-based Race Oncology Ltd. hopes to change those outcomes with a new take on an old drug that slipped through the cracks in the 1980s.