The US Food and Drug Administration has approved the tumour necrosis factor blocker, Remicade (infliximab), for the treatment of ulcerative colitis in children older than six years who have had inadequate response to conventional therapy.
The US Food and Drug Administration has issued a ‘complete response letter’ to GlaxoSmithKline Plc, effectively rejecting its application to market a new combination vaccine for children against three types of bacteria.
Seven new medicines, including a new diabetes treatment, an antibiotic for C. difficile, two drugs for HIV, and combination treatments for hypertension, have received positive opinions from the European Medicines Agency.
The US Food and Drug Administration has approved the monoclonal antibody, Soliris (eculizumab), for a rare paediatric blood disorder called atypical hemolytic uremic syndrome while the EMA has recommended approval of the same indication.
The European Medicines Agency is recommending approval of a new macrocyclic antibiotic for Clostridium difficile, Dificlir (fidaxomicin). Developed by Optimer Pharmaceuticals Inc, the antibiotic was approved by the FDA in May 2011.
The European Medicines Agency has recommended restrictions on the use of Multaq (dronedarone), an anti-arrhythmic medicine marketed by Sanofi SA, due to an increased risk of liver, lung and cardiovascular adverse events.
The European Medicines Agency has started a review of orlistat-containing medicines, which are used to treat obesity, to determine whether very rare cases of liver injury affect the medicines’ overall benefit-risk profile.
A supplemental new drug application for the AIDS medicine, maraviroc (Celsentri/Selzentry), has been withdrawn by its developers pending further studies of the drug’s efficacy as a once-daily treatment.
The US Food and Drug Administration has approved two new indications for the osteoporosis drug, Prolia (denosumab), enabling it to be used for cancer treatment-induced bone loss, according to Amgen Inc, the developer.
The US Food and Drug Administration has reorganised the office that deals with oncology drug products in order to take a more disease-specific approach to the evaluation of these medicines. Richard Pazdur will continue as director.