Blue glowing pill splitting with electric crack, symbolizing disruption in pharma – Cromos Clinical Intelligence Report 50th Edition.
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
Cromos Pharma achieves ISO 9001:2015 certification, showcasing excellence in clinical research quality management
MILESTONE ACHIEVED: Cromos Pharma Earns ISO 9001:2015 Certification When compliance becomes a competitive advantage We are proud to announce that Cromos Pharma has achieved ISO 9001:2015 certification from TMS International Certification Body — a testament to our unwavering commitment to operational excellence in clinical research. Why This Matters In clinical research, ICH GCP compliance is the baseline. ISO 9001:2015 takes us further — it proves we operate within a Read more
Clinical Research Focus. 43rd Edition Sarepta Reverses Course on Elevidys Suspension After FDA Review Earlier this month, Sarepta paused all U.S. shipments of its gene therapy Elevidys following three patient deaths, triggering a rare standoff with the FDA. However, in a swift regulatory turnaround, the agency has now cleared the therapy for continued use in ambulatory DMD patients, citing no Read more

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