Results Mixed for Etrolizumab in Ulcerative Colitis
Etrolizumab is an investigational humanized monoclonal anti-ß7 antibody designed to selectively inhibit α4β7 and αEβ7 integrins.
Gastroenterology
Reduced CDI Recurrence Observed With Investigational Microbiome Therapy
SER-109 contains purified bacterial spores of multiple Firmicute species obtained from the stool of healthy human donors.
Ortikos Now Available for Mild to Moderate Crohn Disease
Ortikos, an anti-inflammatory corticosteroid, is approved as a once-daily treatment for mild to moderate active Crohn disease and for maintenance of clinical remission.
Zenocutuzumab Gets Orphan Drug Designation for Pancreatic Cancer
Zenocutuzumab is a first-in-class bispecific antibody that binds to HER2 and HER3 receptors, thereby blocking the interaction of HER3 with its ligand neuregulin 1 (NRG1) or NRG1-fusion proteins.
Clinical Hold Lifted on Seladelpar for Chronic Liver Diseases
The FDA has lifted the clinical hold on 3 Investigational New Drug applications evaluating seladelpar (CymaBay Therapeutics) for the treatment of non-alcoholic steatohepatitis, primary biliary cholangitis and primary sclerosing cholangitis.
Efficacy of Cannabinoids in Treating IBD Examined
Significant improvements in both clinical symptoms (ie, abdominal pain, general well-being, nausea, diarrhea, and decreased appetite) as well as QoL scores were observed with cannabinoids.
GI Bleeding Rates With P2Y12 Platelet Inhibitors Compared
Ticagrelor and prasugrel, the newer generation of P2Y12-inhibiting antiplatelet agents, were found to be associated with fewer gastrointestinal bleeding events the first year after percutaneous coronary intervention compared with clopidogrel.
FDA Committee Narrowly Votes in Favor of Terlipressin for Hepatorenal Syndrome Type 1
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8 to 7 in favor of the approval of terlipressin for the treatment of adults with hepatorenal syndrome type 1
Risk for COVID-19 Increased for Adults Taking PPIs
Dose-response relationship observed; risk up 3.67-fold for those using PPIs up to twice daily.
Biosimilar Hulio Gets FDA Approval
The Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp; Mylan), a biosimilar to Humira® (adalimumab; AbbVie).
