News & Events

• January 14, 2021
  

  C-Path Announces SHIP-MD 2021 Virtual Workshop

    Multi-stakeholder event will focus on national innovation ecosystem for pediatric medical device development TUCSON, Ariz., January 14, 2021 — The Critical Path Institute (C-Path) in collaboration with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) AdvaMed, the American Academy of Pediatrics (AAP) and multiple pediatric health system leaders,...
• January 7, 2021
  

  Diary for Irritable Bowel Syndrome Symptoms-Constipation is the First Patient-Reported Outcome Consortium Measure Used to Support an FDA-approved Label Claim

  TUCSON, Ariz., January 7, 2021 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces that clinical study results using the Consortium’s Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) were recently included in the expanded label for the drug LINZESS^® (linaclotide). The DIBSS-C was developed by the PRO Consortium’s Irritable Bowel Syndrome (IBS) Working Group to support the evaluation of both primary and key secondary endpoints related to improvements in IBS-C signs and symptoms within the context of clinical trials and is currently in FDA’s Clinical Outcome Assessment Qualification Program. Although the DIBSS-C was not specifically mentioned, results from its abdominal symptom scale were included in the updated label for LINZESS^®. This is the first time a PRO Consortium measure has been used to support a label claim.

• December 16, 2020
  

  C-Path and Diamyd Medical Announce Data Sharing Collaboration to Develop Advanced Drug Development Tools in Type 1 Diabetes

  TUCSON, Ariz., and STOCKHOLM, Sweden. December 16, 2020 — The Critical Path Institute (C-Path) and Diamyd Medical (DMYD B; Nasdaq First North Growth Market) are proud to announce their collaboration to significantly improve the scientific community’s insight into type 1 diabetes (T1D) through Diamyd Medical’s contribution of fully anonymized data from a European Phase III trial to the Trial Outcome Markers Initiative (TOMI) T1D integrated database. The Phase III trial evaluated the use of the diabetes vaccine Diamyd^®, an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. The Data Contribution Agreement (DCA) between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project.

• December 3, 2020
  

  C-Path Selects Aridhia to Support Rare Disease Cures Accelerator-Data and Analytics Platform

    TUCSON, Ariz., December 3, 2020 — The Critical Path Institute (C-Path) today announced it has selected Aridhia to support its Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP). The RDCA-DAP initiative, launched in September 2019 as a collaborative project between C-Path and the National Organization for Rare Disorders® (NORD), will provide a centralized and...
• December 3, 2020
  

  C-Path, Ltd. Announces New Contract with Innovative Medicines Initiative

    DUBLIN, Ireland, December 3, 2020 — Critical Path Institute, Ltd. (C-Path, Ltd.) announced today a new contract with the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU). The new project will leverage C-Path’s global expertise in developing novel product development tools. “The mission of IMI, to improve health by speeding up the development of,...