Drug Trials News for January 2018

Drug Trials News Archive

Drug trial protocol redactions by industry sponsors exposed Drug trial protocol redactions by industry sponsors exposed

Trial protocols are needed for a proper assessment of the veracity of drug trial reports. The researchers, from the Nordic Cochrane Centre in Copenhagen, found widespread redactions in the protocols for commercially sponsored trials they received from research ethics committees in Denmark. The study is believed to be the first systematic assessment of which information in trial protocols pharmaceutical companies do not wish to disclose to independent researchers.

ZINPLAVA®? (bezlotoxumab) - a new therapy for the prevention of recurrence of Clostridium difficile infection - launched in the UK ZINPLAVA®? (bezlotoxumab) - a new therapy for the prevention of recurrence of Clostridium difficile infection - launched in the UK

Bezlotoxumab is the first EC licensed non-antibiotic option indicated to prevent Clostridium difficile infection (CDI) recurrence in high-risk adults

Nintedanib awarded Promising Innovative Medicine designation for malignant pleural mesothelioma with phase II trial showing progression-free survival benefit when added to first-line chemotherapy Nintedanib awarded Promising Innovative Medicine designation for malignant pleural mesothelioma with phase II trial showing progression-free survival benefit when added to first-line chemotherapy

Nintedanib has been designated a Promising Innovative Medicine for the treatment of malignant pleural mesothelioma (MPM) by the UK Medicine and Healthcare Products Regulatory Agency (MHRA). This is an early indication that the MHRA considers nintedanib a promising candidate for the Early Access to Medicines Scheme, which aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need