Dupilumab Gets Breakthrough Therapy Status for Eosinophilic Esophagitis
The designation was based on results from Part A of a double-blind, placebo-controlled, pivotal phase 3 trial.
Miscellaneous Gastrohepatic Disorders
FDA Fast Tracks SSAO Inhibitor for Nonalcoholic Steatohepatitis
TERN-201 is a highly-selective semicarbazide-sensitive amino oxidase inhibitor.
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.
FDA Approves Gimoti Nasal Spray for Diabetic Gastroparesis
The FDA has approved Gimoti™ (metoclopramide; Evoke Pharma) nasal spray for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Human Placental Extract Gets Orphan Drug, Rare Pediatric Disease Status for Necrotizing Enterocolitis
Protego-PD is an oral acellular biotherapeutic derived from post-delivery placentas.
Intravenous Choline Chloride Fast-Tracked for Intestinal Failure-Associated Liver Disease
The FDA has granted Fast Track designation to intravenous choline chloride (Protara Therapeutics), an investigational phospholipid substrate replacement therapy for the treatment of intestinal failure-associated liver disease.
Clinical, Anatomic Improvements With Dupilumab in Eosinophilic Esophagitis Study
Dupilumab was associated with clinical and anatomic improvements in patients with eosinophilic esophagitis, according to results from a pivotal phase 3 study.
Elafibranor Effect Not Significantly Different From Placebo in NASH Study
GENFIT announced that the phase 3 RESOLVE-IT trial of elafibranor in patients with nonalcoholic steatohepatitis (NASH) and fibrosis did not meet its primary and secondary end points.
QOL Similar After Surgery, Antibiotics for Uncomplicated Appendicitis
No difference seen in satisfaction for patients after successful antibiotic treatment versus appendectomy
Mediterranean Diet May Modulate Gut Bacteria in Seniors
Diet tied to increased abundance of specific taxa linked to markers of lower frailty, improved cognition.
