Latest Biopharmaceuticals News

Neurotech International has reported positive long-term safety results for its lead drug candidate NTI164, bolstering its path towards regulatory approval and chronic use in paediatric neurological disorders.

Argent BioPharma has completed its largest commercial shipment of CannEpil® to Ireland, marking a key milestone in its European expansion with a delivery valued at approximately AUD 783,000. The product is fully reimbursed under Ireland’s National Health Insurance scheme, enhancing patient access for refractory epilepsy treatment.

Telix Pharmaceuticals has lodged a European marketing authorization application for TLX101-Px, a novel PET imaging agent targeting glioma brain cancer, aiming to enhance diagnostic precision and patient access across major European markets.

Paradigm Biopharmaceuticals has published a pivotal study in PLOS ONE showing sustained pain relief and joint repair in dogs treated with pentosan polysulfate sodium, reinforcing its potential for human osteoarthritis therapy.

Racura Oncology has developed a pioneering blood test that promises to fast-track key data on its cardioprotective drug RC220, potentially shaving two years off the clinical trial timeline. This innovation also enhances patient safety and recruitment prospects in the ongoing RAC-010 CPACS trial.

Island Pharmaceuticals has raised $9 million to advance its antiviral drug Galidesivir through the FDA’s Animal Rule pathway, targeting inclusion in the US Strategic National Stockpile for biodefense viruses.

Neurotech International has secured ethics approval to launch its Beyond Harmony Phase 3 clinical trial of NTI164 for autism spectrum disorder, marking a key step toward regulatory submissions in Australia and the US.

Neurotech International has secured a Rare Pediatric Disease Designation from the FDA for its lead drug NTI164 targeting Rett syndrome, alongside publishing promising clinical data and raising $8.7 million to fuel further development.

NeuroScientific Biopharmaceuticals has reported promising initial clinical responses from its StemSmart™ Special Access Program treating Fistulising Crohn’s Disease, while preparing for a pivotal Phase 2 trial in 2026.

Argent BioPharma has restructured its acquisition of AusCann assets to sharpen its clinical focus and secured a substantial A$11 million financing facility, positioning itself for growth in 2026.

Paradigm Biopharmaceuticals has secured independent validation of its Phase 2 iPPS biomarker study, published in a leading rheumatology journal, reinforcing the scientific basis for its Phase 3 osteoarthritis trial.

Radiopharm Theranostics has reported promising interim results from its Phase 2b trial of RAD 101, showing high concordance with MRI in brain metastases patients, while progressing multiple other clinical programs and securing a strong cash position to fund operations into 2027.