Australia’s Therapeutic Goods Administration (TGA) has approved CSL Ltd.’s Andembry (garadacimab) for preventing recurrent hereditary angioedema attacks, marking the first global approval for the drug that was discovered and developed in Australia by CSL scientists.
George Medicines, a new spinout from Australia’s George Institute for Global Health, could offer patients better control of their blood pressure as well as fewer side effects thanks to an ultra-low-dose triple combination.
Aussie radiopharma company Advancell Co. Ltd. closed an oversubscribed $112 million series C round that will accelerate clinical development of its pipeline of radionuclide therapies and allow it to expand its manufacturing capacity.
After raising AU$16.75 million (US$10.4 million) in a series A round, Celosia Therapeutics Pty Ltd. is heading toward the clinic with its novel gene therapy that targets TDP-43, a protein directly linked to amyotrophic lateral sclerosis (ALS) pathology.
Dimerix Ltd. and Fuso Pharmaceutical Industries Ltd. signed a license agreement for the development and commercialization of Dimerix’s phase III candidate, DMX-200, for the treatment of focal segmental glomerulosclerosis in Japan for ¥10.5 billion (US$66.5 million) plus royalties.
Certa Therapeutics Pty Ltd. has acquired Occurx Pty Ltd. in a move to strengthen its pipeline to target multiple fibrotic diseases as both companies share a focus on targeting GPR68, a defined G protein-coupled receptor (GPCR) receptor that mediates signaling pathways associated with inflammation and fibrosis and is thought to be a master switch of fibrosis.
At Bio Japan 2024, policymakers and industry leaders pledged to make Japan a land of drug discovery to attract native and foreign drug developers. Like many Asian countries, Japan is harnessing and prioritizing the bio sector to drive economic growth, throwing its weight behind its 10-year Bioeconomy initiative to create bioclusters and increase investment.
SK Bioscience Co. Ltd. gained approval from the Human Research Ethics Committee in Australia to start phase I/II trials of GBP-560, its mRNA-based vaccine candidate for mosquito-borne Japanese encephalitis virus, with funding from Coalition for Epidemic Preparedness Innovations.
Recce Pharmaceuticals Ltd. is progressing synthetic antibiotic Recce-327 to pivotal phase III trials in Indonesia for the treatment of diabetic foot infections. The trial, which is assessing Recce-327 as a topical gel (R327G), is expected to begin in the first quarter of 2025, Recce CEO James Graham told BioWorld.
Paradigm Biopharmaceuticals Ltd. raised AU$16 million (US$10.31 million) in a placement that will allow the company to start a global phase III trial with its lead product, Zilosul (injectable pentosan polysulfate/iPPS), to treat osteoarthritis.