PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.
PERTH, Australia – Australian immuno-oncology company Imugene Ltd. signed a deal to in-license an oncolytic virus known as CF33 from the City of Hope Comprehensive Cancer Center in Los Angeles, in a move to bolster its pipeline and open up a new area of growth for the company, said CEO Leslie Chong.
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) received mixed comments from stakeholders on whether it was necessary to implement a formal good clinical practices inspections program in Australia. Many comments questioned how inspectional findings from a proposed pilot program would be released, but most agreed that a formal inspections program would raise compliance and enhance international competitiveness.
PERTH, Australia – Australian immuno-oncology company Imugene Ltd. signed a deal to in-license an oncolytic virus known as CF33 from the City of Hope Comprehensive Cancer Center in Los Angeles, in a move to bolster its pipeline and open up a new area of growth for the company, said CEO Leslie Chong.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said.
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) received mixed comments from stakeholders on whether it was necessary to implement a formal good clinical practices inspections program in Australia. Many comments questioned how inspectional findings from a proposed pilot program would be released, but most agreed that a formal inspections program would raise compliance and enhance international competitiveness.
PERTH, Australia – Adelaide, Australia-based Bionomics Inc. reported another trial failure with its lead compound, BNC-210, in elderly patients with agitation, but it is still clinging on to hopes that the compound will show a clinical benefit for post-traumatic stress disorder (PTSD).
PERTH, Australia – Adelaide, Australia-based Bionomics Inc. reported another trial failure with its lead compound, BNC-210, in elderly patients with agitation, but it is still clinging on to hopes that the compound will show a clinical benefit for post-traumatic stress disorder (PTSD).
