The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.

From 20 years of research on metabolic change as a result of salt intake, Karen Duggan discovered in 2003 that a naturally occurring molecule in the human body, native vasoactive intestinal peptide (VIP), was capable of reversing fibrosis caused by hypertension and other chronic diseases such as diabetes. From that discovery, Vectus Biosystems Ltd. was founded, and the company has developed a new class of mimetic drug candidates and a drug library based on VIP.

Pharma companies agree that data is king, since after all, their drugs get approved based on the quality of their data.

Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections.

Inoviq Ltd. and The University of Queensland (UQ) are expanding a collaboration to develop an exosome-based ovarian cancer screening test. Researchers from UQ identified and validated exosomal protein and micro-RNA (miRNA) biomarkers that when combined in its OCRF-7 algorithm showed more than 90% accuracy to detect stages I and II ovarian cancer in an independent 500-sample retrospective case-control study, Inoviq CEO Leearne Hinch told BioWorld.