Latest Contract Research Organisations News

BlinkLab has enrolled its first participant in the pivotal FDA 510(k) validation study for its autism diagnostic aid, BlinkLab Dx1, aiming for regulatory submission by the end of 2026.

BlinkLab has completed onboarding its tenth and final clinical site for its pivotal FDA 510(k) trial of an AI-powered autism diagnostic aid, setting the stage for patient enrolment to begin this month.

Racura Oncology has secured governance approval to launch its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib in EGFR-mutated non-small cell lung cancer patients. This milestone sets the stage for a potentially pivotal new approach to overcoming resistance in lung cancer treatment.

Patrys has initiated manufacturing and regulatory steps for RLS-2201, its injectable Quetiapine formulation targeting delirium, aiming for Phase 0 trials in the second half of 2026.

Patrys Limited has appointed Dr Samantha South as its new CEO, aiming to leverage her biotech expertise to fast-track clinical development and commercialisation of its therapeutic antibody pipeline.

OncoSil Medical Ltd has launched an $8 million equity raising to fund the commercial expansion and clinical development of its targeted radiotherapy device for pancreatic cancer, aiming to capitalise on growing European market adoption and upcoming trial catalysts.

Cambium Bio has strengthened its financial footing with a $0.6 million R&D tax refund and a $2.4 million strategic placement, setting the stage for pivotal Phase 3 clinical trials of its lead ophthalmology candidate.

Nyrada Inc. has secured ethics approval to launch a Phase IIa clinical trial for its heart attack drug Xolatryp®, with patient recruitment set for March 2026. The company maintains a solid cash position of AU$7.12 million as it expands its research into oncology.

Arovella Therapeutics has filed an IND application for its lead CAR-iNKT therapy ALA-101, selected a CRO for its upcoming phase 1 trial, and secured $19.4 million in cash to fund clinical progress and pipeline expansion.

Racura Oncology has appointed Beyond Drug Development to oversee its HARNESS-1 Phase 1a/b trial combining RC220 with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward clinical advancement.

Paradigm Biopharmaceuticals has drawn down US$5 million under its convertible note facility to fund the accelerated expansion of its global Phase 3 trial for knee osteoarthritis treatment.

Pathkey.AI reports strong validation of its TrialKey AI platform’s predictive accuracy and announces key leadership changes as it advances toward commercial scale.