Therapeutics/Diagnostics News

The FDA has approved Pfizer’s 2 mg once-daily Velsipity, an oral, selective sphingosine-1-phosphate receptor modulator, to treat adult patients with moderately to severely active ulcerative colitis, according to a company press release.

Topline findings from the phase 3 VIVID-1 trial showed Eli Lilly’s mirikizumab, an interleukin-23p19 antagonist, demonstrated clinical remission and endoscopic response through 52 weeks in adults with moderate to severe Crohn’s disease.

High levels of serum anti-tissue transglutaminase IgA predicted duodenal villous atrophy and could be a reliable measure to avoid biopsy in the diagnosis of adult patients with suspected celiac disease, according to researchers.

Use of glucagon-like peptide 1 agonists for weight loss compared with bupropion-naltrexone was associated with an increased risk for pancreatitis, gastroparesis and bowel obstruction but not biliary disease, researchers reported in JAMA.

The FDA has granted de novo clearance to ProciseDx Inc. for its therapeutic drug monitoring tests for Humira and Remicade, as well as their biosimilars, in patients with inflammatory bowel disease, according to a company release.

The FDA has issued a safety alert warning patients and health care providers of a “risk of invasive, potentially fatal disease” linked to probiotic use among preterm infants in hospital settings.

The FDA has approved subcutaneous administration of Takeda Pharmaceuticals’ Entyvio for maintenance therapy in adult patients with moderate-to-severe ulcerative colitis following induction therapy via IV administration of the biologic.

Adolescents and young adults with ulcerative colitis are at risk for poor adherence to maintenance treatment with 5-aminosalicylic acid in the first year, highlighting the importance of physician follow-up, data showed.

Patients with inflammatory bowel disease who reinitiated infliximab treatment after using a biosimilar had a threefold increased risk for discontinuation over time due to unwanted response, according to research.

Alcohol use at initiation of direct-acting antiviral treatment was not associated with reduced odds for achieving sustained virologic response among veterans with chronic hepatitis C virus infection, according to data in JAMA Network Open.