News & Events
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September 17, 2018
Critical Path Institute and SIGNATOPE GmbH Team Up to Advance Research on Biomarkers for Drug-induced Organ Injuries
TUCSON, Ariz. and REUTLINGEN, September 17, 2018 — Critical Path Institute’s Predictive Safety Testing Consortium (PSTC) and SIGNATOPE GmbH are excited to announce a new project, joining efforts on analyzing and qualifying promising protein safety biomarkers in mouse, rat, dog, monkey, and human. The work is expected to increase understanding of drug-induced toxicities...... -
January 22, 2018
Critical Path Institute Receives Regulatory Support for Liver Injury Biomarker
Tucson, AZ — January 22, 2018 — Critical Path Institute (C-Path) announced today that the European Medicines Agency (EMA) has issued a Letter of Support for measurement of glutamate dehydrogenase (GLDH) as a biomarker of hepatocellular liver injury. The letter was awarded to C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC)...... -
October 17, 2016
IMI SAFE-T and C-Path PSTC Obtain Regulatory Support for New Liver Safety Biomarkers
Oct 17, 2016 IMI SAFE-T and C-Path PSTC Obtain Regulatory Support for New Liver Safety Biomarkers US FDA and EMA Letters of Support Pave the Way for Clinical Qualification The Innovative Medicines Initiative (IMI) SAFE-T (Safer and Faster Evidence Based Translation) Consortium and Critical Path Institute (C-Path) Predictive Safety Testing Consortium (PSTC)...... -
April 13, 2015
Critical Path Institute Secures Regulatory Support For Skeletal Muscle Safety Biomarkers
April 13, 2015 Critical Path Institute Secures Regulatory Support For Skeletal Muscle Safety Biomarkers FDA and EMA Letters of Support Suggest Valuable Research Potential TUCSON, Ariz., April 8, 2015 – The Critical Path Institute (C-Path) announced today that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued Biomarker...... -
January 12, 2015
Critical Path Institute Secures Additional Regulatory Support For Kidney Safety Biomarkers
January 12, 2015 Critical Path Institute Secures Additional Regulatory Support For Kidney Safety Biomarkers EMA Letter of Support Opens Door for Clinical Qualification TUCSON, Ariz., January 12, 2015 – The Critical Path Institute (C-Path) announced today that the European Medicines Agency (EMA) issued a first-of-its kind Biomarker Letter of Support for two essential kidney safety......