The 2022-2026 Workplan of the Accelerate Clinical Trials in the EU (ACT EU) initiative has been published by the European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA). The ACT EU, launched on January 2022, seeks to...
The webinar is organized by the European CRO Federation (EUCROF) and it will be held online on October 5th from 10:00 to 11:30 am (CEST). People-centered clinical trials are a growing concept in Clinical Trials, so it is crucial to foresee and develop initiatives...
The US Food and Drug Administration (FDA) has approved Bluebird Bio’s one-time beta-thalassaemia treatment Zynteglo, also known as betibeglogene autotemcel (beti-cel), as the first cell-based gene therapy for the treatment of patients with beta-thalassaemia who...
The Heads of Medicines Agencies - European Medicines Agency (HMA - EMA) Big Data Steering Group is organizing the 3rd EU Big Data Stakeholders Forum on Thursday, 1 December 2022. The objectives of the meeting are: Inform stakeholders on the delivery of data...
In clinical practice, patients are often prescribed more than one drug which can result in a drug-drug interaction (DDI). The European Medicines Agency (EMA) has published the “Draft International Council for Harmonisation (ICH) Guideline M12 on drug interaction...
The Heads of Medicines Agencies - European Medicines Agency (HMA - EMA) Big Data Steering Group is organizing the 3rd EU Big Data Stakeholders Forum on Thursday, 1 December 2022. The objectives of the meeting are: Inform stakeholders on the delivery of data...
The European Medicines Agency (EMA) has launched a pilot project to i) assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as...
The U.S. Food and Drug Administration (FDA) has recently published a guidance on neonatal clinical pharmacology studies. This guidance is intended to assist sponsors of investigational new drug applications (INDs) as well as applicants of new drug applications...
Good paediatric biomarkers are critical for the decision-making process in child healthcare. However, reference intervals used in pediatric care today remain highly inconsistent across a broad range of common clinical biomarkers. This review paper assessed...
The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) for the treatment of severe haemophilia A in adults who do not have factor VIII inhibitors and no...