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
Elevidys Gene Therapy Suspended After Patient Deaths – Sarepta News Banner
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
Clinical Trial Rescue: How to Spot Trouble and Act Fast Even the most carefully designed clinical trials can falter. Whether due to operational breakdowns, poor enrollment, or misaligned CRO performance, a promising study can suddenly veer off course. That’s when a clinical trial rescue becomes not just an option — but a necessity.  In this article, we explore what a clinical trial rescue entails, how Read more
Clinical Research Focus 42nd edition | Cromos Pharma | EMA Recommends Conditional Approval of Zemcelpro for Blood Cancer Patients Lacking Donors
Clinical Research Focus. 42nd Edition EMA Recommends Conditional Approval of Zemcelpro for Blood Cancer Patients Lacking Donors The EMA has recommended conditional marketing authorisation for Zemcelpro, a novel stem cell therapy developed to support patients with blood cancers who require a stem cell transplant but lack a suitable donor. By expanding umbilical cord blood cells, Zemcelpro aims to improve engraftment Read more

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