MELBOURNE, Australia – Researchers at the Murdoch Children’s Research Institute in Melbourne are pushing the boundaries on creating kidney tissue from stem cells. For more than two decades, Melissa Little and her team at Murdoch have investigated the molecular and cell development basis of kidney disease and the potential for regeneration. The team has developed approaches for directing the differentiation of human pluripotent stem cells to human kidney organoids and is applying that knowledge to disease modeling, drug screening, cell therapy and tissue engineering.
PERTH, Australia – Sydney-based Kazia Therapeutics Ltd.’s shares soared nearly 82% this week on positive interim results for lead molecule GDC-0084 in a phase II glioblastoma trial.
MELBOURNE, Australia – Researchers at the Murdoch Children’s Research Institute in Melbourne are pushing the boundaries on creating kidney tissue from stem cells.
Australia's Therapeutic Goods Administration (TGA) proposed classifying active implantable medical devices (AIMDs), their accessories and active devices for controlling, monitoring or influencing the performance of an active device and software as high-risk class III devices. However, the agency has rethought the notion of up-classifying all implant device accessories after blowback from industry.
Australia's Therapeutic Goods Administration (TGA) recently posted a draft guidance for regulation of software as a medical device, but the Medical Technology Association of Australia expressed a preference for an international standard for risk classification.
Device makers were generally supportive of the Australian Therapeutic Goods Administration (TGA) proposal to up-classify active medical devices with an integrated diagnostic function that significantly determines patient management by the device (such as closed loop systems or automated external defibrillators) to class III, the highest risk designation used by TGA.
MELBOURNE, Australia – Although Australia was one of the first movers in the regenerative medicine space, until now a cohesive plan for investing in regenerative medicine was holding the sector back.
PERTH, Australia – Although medical device industry stakeholders agreed in principle with the Australian Therapeutic Goods Administration's (TGA) proposal to align its classification with the EU's for implantable spinal devices, they viewed the interpretation of the EU Medical Device Regulation (MDR) classification rule for these devices differently.
Although Australia's Therapeutic Goods Administration (TGA) approved its first CAR T therapy in 2018, the country is lacking a system to reimburse those advanced therapies, and industry is calling on government to revalue gene therapies.
PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. is poised to extend its global footprint to the U.S. and Europe following its AU$35 million (US$24 million) capital raise.
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