PUBLICATIONS

Clinical Research Focus. 44th Edition NIH Scientists Advance Gene-Editing Approach for Late-Onset Tay-Sachs NIH researchers have successfully used gene-editing to boost enzyme activity and ease symptoms of late-onset Tay-Sachs in human cells and mice. This breakthrough could pave the way for future therapies targeting Tay-Sachs and other lysosomal storage disorders. Learn more Milestone Achieved: Cromos Pharma Earns ISO 9001:2015 Certification Read more

Rare Disease CRO Services: Precision in the Face of Unique Challenges Rare diseases, despite their individual scarcity, impact millions of lives worldwide and demand a specialized approach to drug development. With over 10,000 distinct rare diseases affecting around 400 million people globally, any single condition may involve only a handful of patients. This creates exceptional complexity for clinical trials, requiring operational agility, scientific innovation, and strong Read more

From Tariff-Free to Targeted: How the EU–US Trade Deal Puts Pharma in the Crosshairs The July 2025 EU–US trade agreement brought relief to many industries by averting a 30% U.S. duty on European goods. But for pharmaceuticals, the deal marked the end of a long-standing safe harbor. A new ceiling of 15% tariffs on EU exports, including branded medicines, has upended decades of tariff-free transatlantic trade and thrust the Read more

Global Oncology Trials, Local Relevance: Why the FDA Just Raised the Bar The FDA’s recent Complete Response Letter to Genentech’s BLA for Columvi (glofitamab) + GemOx in second‑line diffuse large B-cell lymphoma (DLBCL) has sent a crystal-clear signal: global trial data must be demonstrably relevant to U.S. patients. What Went Wrong? The phase III STARGLO trial enrolled 274 patients across 62 sites in 13 countries, but only 9% Read more