Latest Pharmaceuticals News

Pharmaceutical manufacturer ANO has been hit with a US FDA Import Alert, joining several Australian peers amid wider regulatory tensions. The company is mobilising expert consultants and preparing a petition to lift the alert within weeks.

Island Pharmaceuticals has been granted a key US patent for Galidesivir, extending intellectual property protection through 2031 for treating filoviridae viruses including Marburg and Ebola. This milestone aligns with the company’s clinical development strategy and recent FDA regulatory progress.

Island Pharmaceuticals reports ongoing FDA review of its antiviral Galidesivir, with no adverse feedback received as the regulator takes extra time to finalise guidance.

Mayne Pharma reports mixed early FY26 results with strong prescription growth in Women’s Health and improved Dermatology margins, while strategic reviews and litigation loom.

Avecho Biotechnology is close to completing recruitment for the interim analysis cohort of its pivotal Phase III trial testing a CBD capsule for insomnia, with results expected in the first half of 2026.

Anatara Lifesciences reports encouraging pre-clinical results for its anti-obesity candidate AOC, demonstrating significant reductions in weight regain and visceral fat in mice. However, a delay in mechanism of action studies pushes full data release to January 2026.

Island Pharmaceuticals has inked a Master Service Agreement with Texas Biomedical Research Institute, enhancing its strategic position to advance Galidesivir through the FDA Animal Rule pathway. This partnership aligns with US government priorities on viral threats and sets the stage for a planned clinical program in early 2026.

Recce Pharmaceuticals has won a significant Australian Government R&D tax incentive, unlocking up to A$85 million for its synthetic anti-infective programs worldwide, including a pivotal Phase 3 clinical trial.

Neuren Pharmaceuticals’ partner Acadia secures FDA approval for DAYBUE STIX, a new powder formulation of trofinetide offering greater flexibility for Rett syndrome patients. This milestone expands treatment options and sets the stage for increased royalty revenue in 2026.

Acrux Limited has sold the US registration and distribution rights for its Prilocaine 2.5% and Lidocaine 2.5% cream for US$550,000, redirecting resources towards its growing Hormone Replacement Therapy portfolio.

Algorae Pharmaceuticals has unveiled breakthrough synergy predictions from its AI platform AlgoraeOS v2, spotlighting 90 high-potential CBD-drug combinations and surpassing models from Google DeepMind.

Bioxyne Limited has secured a pioneering manufacturing and supply agreement to enter the emerging medicinal cannabis markets of Costa Rica and Panama, positioning itself as a first mover with promising revenue potential.