The FDA has approved a new ready-to-dilute liquid formulation of Akynzeo® injection (fosnetupitant/palonosetron; Helsinn) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, in combination with dexamethasone in adults.
Positive topline results were announced from the phase 3 True North trial evaluating the efficacy of ozanimod as an induction and maintenance therapy for adults with moderate to severe ulcerative colitis.
The FDA has approved Tecentriq® in combination with Avastin® for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
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.
Dupilumab was associated with clinical and anatomic improvements in patients with eosinophilic esophagitis, according to results from a pivotal phase 3 study.
At week 10, filgotinib 200mg met the primary end point with a significantly higher proportion of patients achieving clinical remission compared with placebo.
The FDA has approved Qinlock™ (ripretinib; Deciphera) for the treatment of adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
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.
“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.
GlaxoSmithKline (GSK) Consumer Healthcare is voluntarily recalling 5 lots of Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder due possible plastic contamination. According to the Company, it is possible that the products may contain green plastic pieces or shavings from the bottle cap.
