Latest Biosecurity News

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

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.

Island Pharmaceuticals has submitted critical responses to the FDA, advancing the development of its antiviral Galidesivir under the Animal Rule pathway. The company awaits FDA feedback expected by early January 2026, setting the stage for upcoming Marburg virus studies.

Island Pharmaceuticals has secured over $1 million through option exercises by directors and major shareholders, bolstering its cash reserves to advance the clinical and regulatory development of its broad-spectrum antiviral, Galidesivir.

Island Pharmaceuticals has secured membership in the Medical Countermeasures Coalition, positioning its antiviral Galidesivir for critical US government stockpiling and regulatory milestones.

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.

Island Pharmaceuticals will host a webinar to discuss the FDA's feedback on the clinical development and regulatory approval of its antiviral drug Galidesivir, including key considerations under the FDA's Animal Rule and Priority Review Voucher eligibility.

Farm Pride Foods reported a solid $3.58 million net operating cash inflow for the September quarter, despite ongoing pricing pressures. The company is investing in operational upgrades and has commenced construction of a large new hen rearing farm in Victoria.

Island Pharmaceuticals has submitted a detailed briefing to the FDA aiming to accelerate approval of its antiviral Galidesivir for Marburg virus under the Animal Rule, with feedback expected by November.

Murray Cod Australia Ltd reports a landmark FY25 profit turnaround driven by record biomass growth and infrastructure expansion, setting the stage for a commercial inflection in FY26.

Island Pharmaceuticals has won a crucial FDA Type C meeting to discuss fast-tracking its antiviral Galidesivir for Marburg virus treatment, with written feedback expected by November.

Select Harvests has confirmed the presence of varroa mite in its South Australian orchard but reports no immediate impact on the 2026 almond crop. The company is working closely with authorities to contain the issue and is adjusting its bee sourcing strategy for future seasons.