After raising AU$29 million (US$19.44 million) in a series A round, Rage Biotech Pty Ltd. is beginning phase I trials of its lead candidate, RB-042, an inhaled splice-switching oligonucleotide for treating chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases.
After raising AU$29 million (US$19.44 million) in a series A round, Rage Biotech Pty Ltd. is beginning phase I trials of its lead candidate, RB-042, an inhaled splice-switching oligonucleotide for treating chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases.
After raising AU$29 million (US$19.44 million) in a series A round, Rage Biotech Pty Ltd. is beginning phase I trials of its lead candidate, RB-042, an inhaled splice-switching oligonucleotide for treating chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases.
The COVID-19 pandemic amplified concerns over medical device shortages, prompting the U.S. FDA to develop guidance on the topic in November 2023. Australia’s Therapeutic Goods Administration is eyeing a guidance to address the very same problem, although the agency seems wary of whether to formally develop a guidance on device shortages.
The U.S. FDA has cleared Tessera Therapeutics Inc.’s IND application for TSRA-196, its lead in vivo gene editing therapy for α-1 antitrypsin deficiency (AATD). The Australian Human Research Ethics Committee (HREC) has also granted approval for the company to begin the phase I/II clinical study.
Australia’s Therapeutic Goods Administration posted a proposed rework of the agency’s conformity assessment procedures that would align with EU regulations, but the agency stated clearly that it is aware of some of the hazards of further alignment with the troubled European regulations.
Payers had their hands full in 2025 dealing with the raft of medical technologies that came through the globe’s regulatory review processes, although the nature of many of those challenges were conventional. On the other hand, payers struggled to keep pace with both the volume of conventional devices and the novelty of AI-driven devices in 2025, a problem that will carry over into the coming year.
The Trump administration has made known that it intends to foster rapid adoption of AI, starting with a repeal of an executive order (EO) issued by the Biden administration. Now, the White House has issued an EO that would override state AI law, a move that addresses a task that Congress to date has failed to complete.
Rona Therapeutics Co. Ltd. has announced the submission of RN-5681 to the Australian Human Research Ethics Committee (HREC), and anticipates dosing to begin in a phase I trial in the first quarter of next year.
Kazia Therapeutics Ltd. raised AU$50 million (US$33.15 million) in a private placement of equity securities to advance lead candidate paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor in clinical trials for brain cancer and advanced breast cancer.
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