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 antimicrobial innovation.

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The European Health Data Space (EHDS): A Game Changer for Clinical Research and Pharma?

The EHDS is poised to revolutionize how health data is accessed and shared across the EU, offering a wealth of opportunities for CROs and biopharma companies. From accelerating real-world evidence generation to boosting cross-border trial execution and patient recruitment, the EHDS could reshape the future of digital health and clinical research.

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Diversity in Clinical Trials: The Path Forward Amid Uncertainty

Diversity in clinical research is essential—not optional. Yet despite new FDA mandates requiring Diversity Action Plans, recent policy shifts have introduced uncertainty. Underrepresentation of racial and ethnic minorities, older adults, and underserved groups continues to impact equity and efficacy in clinical outcomes.

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EMA Endorses Groundbreaking AI Tool to Improve MASH Diagnosis in Clinical Trials

The European Medicines Agency (EMA) has issued its first-ever qualification opinion for an AI-based method. The AIM-NASH tool assists pathologists in evaluating liver biopsy samples to determine the severity of MASH, enhancing accuracy and consistency in clinical trials and paving the way for faster development of new treatments.

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World Kidney Day: 5 Breakthroughs Changing the Game

Kidney disease often goes undiagnosed until it’s advanced. But emerging innovations—from lab-grown kidneys to next-gen diagnostics—are reshaping the outlook. In honor of World Kidney Day 2025, here are five breakthroughs transforming kidney care around the world.

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HHS to Cut 10,000 Jobs and Restructure Amid $1.8B Cost-Saving Plan

The U.S. Department of Health and Human Services will eliminate 10,000 jobs and consolidate 28 agencies into 15 under a $1.8B cost-saving initiative. The FDA will see the largest impact, with 3,500 positions cut. This sweeping move is part of RFK Jr.’s “Make America Healthy Again” plan to focus more sharply on chronic disease prevention.

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Visby Medical Gets FDA Nod for First Fully At-Home STI Test for Women

Visby Medical has received FDA clearance for the first over-the-counter, fully at-home sexual health test for women. The single-use, PCR-based kit screens for chlamydia, gonorrhea, and trichomoniasis, delivering results to a smartphone in just 30 minutes. With accuracy comparable to lab-based testing, this approval marks a major step forward in expanding private, accessible diagnostics for common STIs.

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Omalizumab Outperforms Oral Immunotherapy for Multi-Food Allergies

An NIH-funded study found that 36% of patients treated with omalizumab could tolerate at least 2 grams of peanut and two other food allergens, compared to only 19% in the oral immunotherapy group. Omalizumab also led to fewer allergic reactions, making it a safer and more effective option for people with multiple food allergies.

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Merck Inks $200M Deal with Hengrui for Promising Midstage Heart Drug

Merck & Co. is investing $200 million upfront for the ex-China rights to HRS-5346, a phase 2 oral drug candidate targeting elevated lipoprotein(a), a key cardiovascular risk factor affecting 1.4 billion people globally. The deal with China’s Hengrui Pharma could reach $1.77 billion in milestones, boosting Merck’s cardio-metabolic pipeline as it joins the race with Eli Lilly and AstraZeneca in the Lp(a) inhibitor space.

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