A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit.
Ibio Inc. has received clinical trial notification (CTN) acknowledgement from Australia’s Therapeutic Goods Administration (TGA), as well as Human Research Ethics Committee approval, for IBIO-600, enabling the initiation of a first-in-human trial in Australia.
Alltrna has obtained approval in Australia to initiate a phase I trial of AP-003 in healthy volunteers under Australia’s TGA clinical trial notification scheme. AP-003 is a chemically modified, engineered transfer RNA (tRNA) oligonucleotide encapsulated in a clinically validated, liver-directed lipid nanoparticle.
