PREVU cholesterol test trial
This article was originally published in The Tan Sheet
A clinical trial evaluating the PREVU Point of Care skin sterol test will measure the relationship between skin sterol values and already-established coronary artery disease markers such as ankle/brachial blood pressure index and vascular compliance, International Medical Innovations announces. The study will follow 100 patients at high risk for cardiovascular disease and not taking cholesterol-lowering medication. The product measures cholesterol levels that accumulate in skin tissue. McNeil Consumer & Specialty Pharmaceuticals reached a licensing agreement with IMI in June. The firms are developing PREVU predictive tests for medical, laboratory and home use (1"The Tan Sheet" June 7, 2004, p. 10)...
You may also be interested in...
McNeil Consumer Health is seeking to leverage the potential Rx-to-OTC switch of J&J/Merck's Mevacor (lovastatin) with an agreement to license International Medical Innovations' predictive tests for coronary artery disease (CAD)
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.