PUBLICATIONS

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

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

Sarepta Pauses Elevidys Shipments After Three Patient Deaths Linked to Gene Therapy On July 22, Sarepta Therapeutics announced it would pause all shipments of Elevidys in the US, its gene therapy for Duchenne muscular dystrophy (DMD). The decision follows an official FDA request and the reported deaths of three patients, two of whom were treated with Elevidys, and one who received a similar investigational therapy in a Read more