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.
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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
