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5 stories you may have missed in July
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Healio Gastroenterology and Liver Disease has compiled a list of some of the top stories we reported in July.
Our readers were most interested in an FDA Boxed Warning, as well as an FDA new drug application for Helicobacter pylori.
Surgery fellows performing more endoscopies
The number of endoscopies performed by surgery fellows has increased during the last 10 years, and that trend is likely to continue, according to data presented at Digestive Disease Week.
David Morrell, MD, a general surgery resident at Penn State Health Milton S. Hershey Medical Center, said in his presentation that endoscopy has become a common part of surgical practice, but little information is available on the volume of endoscopic surgery. READ MORE.
FDA accepts NDA for H. pylori therapy
RedHill Biopharma announced that the FDA has accepted a new drug application for its Helicobacter pylori infection therapy, Talicia.
Additionally, the NDA for Talicia (RHB-105) has been granted priority review by the FDA and was assigned a Prescription Drug User Act action date of sometime in November, according to a company press release. READ MORE.
FDA approves boxed warning for Xeljanz in UC
The FDA recently issued a safety alert and approved new Boxed Warning for the 10-mg, twice-daily dosage of tofacitinib in patients with ulcerative colitis; the warning comes after increased blood clot and death risks were seen in a rheumatoid arthritis trial.
Additionally, the FDA alert states that the approved use of tofacitinib (Xeljanz, Pfizer) for UC should be limited to specific patients who are not treated effectively or who experience severe side effects with certain other medicines. READ MORE.
Gastric cancer rates higher among patients treated for H. pylori
Patients who receive antibiotic treatment for Helicobacter pylori infection experience gastric cancer at rates higher than the general population, and several risk factors can increase that risk even further, according to data presented at Digestive Disease Week.
Elizabeth Dong, MD, of the department of gastroenterology at Kaiser Permanente Los Angeles, said H. Pylori is a known risk factor for gastric cancer, but there are no clear guidelines on how it should impact surveillance. READ MORE.
Serum-based biomarker test yields positive diagnostic accuracy for Crohn’s disease
The Mucosal Healing Index, a serum-based biomarker assay, demonstrated efficacy in identifying mucosal inflammation and similar accuracy to fecal calprotectin in patients with Crohn’s disease, according to a study presented at Digestive Disease Week.
“Biomarker-based management has been shown to improve outcomes [in Crohn’s disease],” Robert Battat, MD, told Healio Gastroenterology and Liver Disease. READ MORE.