On August 2015, TiGenix received the FDA endorsement of a Special Protocol Assessment for a pivotal Phase III study for Biologics License Application in the U.S. Since the granting of the SPA, further confirmatory positive results have been obtained from the European Phase III study of Cx601 , the largest randomized study performed so far in Crohn’s disease patients with complex perianal fistulas. Subsequently, TiGenix submitted a Marketing Authorization Application to the European Medicines Agency in March 2016.
Category: Crohn’s Disease
Want to Be More Productive? Start By Scrapping Your To-Do List.
That is the question that Ari Meisel faced after being diagnosed with Crohn’s disease, a chronic condition that affects the digestive tract and causes severe pain and fatigue. Because of his illness, Meisel would sometimes be limited to one hour of work per day.
Teaching Computers to Recognize Sick Guts: Machine-Learning and the Microbiome
A new proof-of-concept study by researchers from the University of California San Diego succeeded in training computers to “learn” what a healthy versus an unhealthy gut microbiome looks like based on its genetic makeup. Since this can be done by genetically sequencing fecal samples, the research suggests there is great promise for new diagnostic tools that are, unlike blood draws, non-invasive.