PUBLICATIONS

Clinical Research Focus. 39th Edition Gepotidacin Receives FDA Approval for UTI Treatment The FDA has approved GSK’s gepotidacin (Blujepa) for treating uncomplicated urinary tract infections (uUTIs) in females aged 12 and up. Backed by strong results from the EAGLE-2 and EAGLE-3 Phase 3 trials, this is the first new oral antibiotic for uUTIs in over two decades—a significant milestone in Read more

The European Health Data Space (EHDS): A Game Changer for Clinical Research and Pharma? The European Health Data Space (EHDS) is an initiative introduced by the European Commission to enhance the sharing and use of health data across the EU. It aims to facilitate primary and secondary use of electronic health data while ensuring patient rights and data privacy. Primary use (for patients and healthcare providers) focuses on improving Read more

World Kidney Day: Top 5 Breakthroughs in Kidney Disease Treatment Chronic kidney disease (CKD) is an escalating global health challenge, impacting over 35 million individuals in the United States and an estimated 100 million across Europe. Despite its widespread prevalence, CKD remains underdiagnosed until its advanced stages, leading to severe complications, including kidney failure, cardiovascular disease, and increased mortality. However, recent scientific and medical advancements are transforming the Read more

Diversity in Clinical Trials: The Path Forward Amid Uncertainty Ensuring diversity in clinical trials is more than a regulatory requirement—it is essential for developing safe and effective therapies that benefit all patients. Historically, clinical research has failed to adequately represent racial and ethnic minorities, older adults, and other underrepresented groups, leading to knowledge gaps in drug efficacy and safety across different populations. The consequences Read more