Notizie Newsletter
Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
Olanzapine 10 mg added to standard antiemetic therapy including aprepitant, palonosetron, and dexamethasone has been recommended for the prevention of chemotherapy-induced nausea and vomiting. Guidelines suggest that a dose reduction to 5 mg should be considered to prevent ...Leggi tutto
FDA Approves Generic Everolimus Tablets
December 10, 2019 - The FDA has approved 2 abbreviated new drug applications (ANDAs) for everolimus tablets for the treatment of patients with advanced hormone receptor–positive, HER2-negative breast cancer in postmenopausal women; advanced renal cell carcinoma; progressive ...Leggi tutto
FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug
December 11, 2019 - The U.S. Food and Drug Administration today posted a warning letter to Alkermes, Inc. of Massachusetts, for misbranding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated ...Leggi tutto
How will pharmacovigilance look in 2030?
December 10, 2019 - Smarter collection and reporting of safety reports of suspected adverse reactions, measurement of on-market performance of medicines, and improved engagement between regulators, patients and healthcare professionals will be key elements of pharmacovigilance ...Leggi tutto
Six-year review shows success of the EU signal management system in improving safe use of medicines
December 11, 2019 - In the first six years since the implementation of the 2012 EU pharmacovigilance legislation, the EU network has demonstrated its ability to reliably detect, assess and manage safety signals for medicines, opening a new era for patient protection and ...Leggi tutto
Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study
Treatment for renal cell carcinoma has been revolutionised by inhibitors of VEGF receptor. Previous studies have suggested that treatment with a VEGF receptor (VEGFR) tyrosine kinase inhibitor might be effective in patients who had previous checkpoint inhibitor therapy. ...Leggi tutto