Lumasiran Granted Priority Review for Primary Hyperoxaluria Type 1
The FDA has accepted for Priority Review the New Drug Application for lumasiran for the treatment of primary hyperoxaluria type 1.
Gastrohepatic Disorders
Updated Guidelines Issued for Management of Diverticulitis
CT scan is most appropriate initial imaging modality; lifestyle interventions can reduce risk.
Filgotinib Associated With Clinical Remission in Ulcerative Colitis Study
At week 10, filgotinib 200mg met the primary end point with a significantly higher proportion of patients achieving clinical remission compared with placebo.
Corticosteroids for IBD May Up Risk for Severe COVID-19
TNF antagonists not associated with severe COVID-19 in patients with inflammatory bowel disease.
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.
Microbiome-Based Therapy Looks Promising for Recurrent C difficile Infection
“These positive preliminary findings represent a major step forward towards bringing an innovative, non-antibiotic option to patients that may help restore their gut microbiome,” said Per Falk, Ferring’s President and Chief Science Officer.
Guidelines Issued for Managing Eosinophilic Esophagitis
Topical glucocorticosteroids recommended over no treatment.
GI Manifestations Seen for Nearly 1 in 3 With SARS-CoV-2
Significant portion have diarrhea, nausea, vomiting, and/or abdominal discomfort before respiratory symptoms
New Drug Product: Talicia
This slideshow shows drug information for Talicia. Click here for the complete Talicia monograph. For a downloadable version of this slideshow, click here.
Amneal’s Nizatidine Oral Solution Recalled Due to NDMA Concerns
The Food and Drug Administration (FDA) is alerting healthcare professionals and consumers of a voluntary recall of 3 lots of Amneal’s Nizatidine Oral Solution (15mg/mL) due to potential contamination with N-Nitrosodimethylamine (NDMA), a probable human carcinogen.
