Regulatory harmonization and reliance are the orders of the day at this year’s meeting of the International Medical Device Regulators Forum (IMDRF), but that does not mean individual regulators are waiting for IMDRF to act on their own imperatives.

A new spinout from Monash University in Melbourne, Australia, is tackling biology to better understand immune cell function and to find targets that were thought to be undruggable. Onko-innate co-founders Jai Rautela and Nicholas Huntington first worked together at Huntington’s lab at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Melbourne where they studied the role of natural killer (NK) cells in tumor immunology and discovered some interesting regulatory pathways for cytokine responses.

Eilean Therapeutics LLC has announced clearance by the Human Research Ethics Committee in Australia for a first-in-human phase I trial of balamenib (ZE63-0302), an oral small-molecule inhibitor of the menin-KMT2A interaction.

Pharmaust Ltd.’s monepantel met its primary safety endpoints and showed positive signals of potential efficacy in a phase I trial in patients with motor neuron disease (MND)/amyotrophic lateral sclerosis (ALS). With these results, the company will now progress to a pivotal phase II/III trial by midyear, Pharmaust CEO Michael Thurn told BioWorld.

A new spinout from Monash University in Melbourne, Australia, is tackling biology to better understand immune cell function and to find targets that were thought to be undruggable.

In a move to build up its dominance in the radiopharma market, Telix Pharmaceuticals Ltd. said it plans to acquire radioisotope production technology firm Artms Inc. and its advanced cyclotron-based isotope production platform, manufacturing plant and stockpile of ultra-pure rare metals.

A new spinout from Monash University in Melbourne, Australia, is tackling biology to better understand immune cell function and to find targets that were thought to be undruggable.

Pharmaust Ltd.’s monepantel met its primary safety endpoints and showed positive signals of potential efficacy in a phase I trial in patients with motor neuron disease (MND)/amyotrophic lateral sclerosis (ALS). With these results, the company will now progress to a pivotal phase II/III trial by midyear, Pharmaust CEO Michael Thurn told BioWorld.

To understand the focus of startup Insamo Inc., one need look no further than its name, which co-founder and CEO Timothy Craven described as “portmanteau of ‘internally satisfied molecules,’” highlighting its efforts to create orally administered and membrane-permeable cyclic peptides across a range of disease areas.

With the number of people with dementia in Australia expected to nearly double by 2054, the federal government is funding a new AU$50 million (US$32.76 million) biomedical and med-tech incubator program to develop new therapies, medical devices and digital health technologies to address dementia and cognitive decline.