IDDI Reports Successful Partnership with TiGenix for Approval of ChondroCelect®
Louvain-la-Neuve – IDDI (International Drug Development Institute), a corporation based in Belgium, reports that its collaboration with TiGenix resulted in the approval by European Medicines Agency for the Evaluation of Medicinal Products (EMEA) of ChondroCelect® for the treatment of full thickness cartilage defects in the knee. IDDI has partnered with TiGenix for their clinical development program, including a phase III clinical trial comparing ChondroCelect® to the present standard-of-care surgical intervention called micro-fracture. The results of this pivotal clinical trial have also been published in the February 2008 issue of the American Journal of Sports Medicine and awarded the Hughston Award, given for the most outstanding paper that appeared in the AJSM the year prior to the award.
IDDI's trial design and statitistics were instrumental in providing strong statistical results while IDDI's data management capabilities were key in accelerating the preparation and validation of efficacy and safety data for the analyses reviewed by the agency.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
