The European Medicine Agency has announced a review of ibuprofen medicines taken at high doses because of the risk of cardiovascular disease. The review covers medicines taken orally, but not topical treatments such as creams and gels.
The European Medicines Agency has selected the first two of what may be several medicines to be reviewed under its ‘adaptive licensing’ pilot project. The agents, which haven’t been identified, will be examined by stakeholders, including HTA bodies, to determine their suitability for future marketing.
The US Food and Drug Administration has approved a new recombinant product for the treatment of Haemophilia A, an inherited, sex-linked blood clotting disorder that is caused by defects in the Factor VIII gene.
The European Medicines Agency is recommending conditional approval of a new treatment for Duchenne muscular dystrophy (DMD), a genetic disease that can lead to loss of muscle function. The drug, Translarna (ataluren), acts by stimulating dystrophin production.
The US Food and Drug Administration has approved the first gene-based test to identify certain antigens in red blood cells that could prevent the successful transfusion of blood from a donor to a patient. By using the test, physicians can determine the compatibility of donor and patient cell types.
Merck & Co Inc said that is suspending a Phase 3 study of the experimental treatment vintafolide for platinum-resistant ovarian cancer on advice from the trial’s data safety monitoring board because the product didn’t show efficacy for progression-free survival.
The US Food and Drug Administration has approved a new first-line indication for Arzerra (ofatumumab), a CD20-directed monoclonal antibody. This is for use in combination with chlorambucil for chronic lymphocytic leukaemia (CLL) in patients who can’t receive fludarabine.
The US Food and Drug Administration has approved a third tablet therapy to treat a respiratory allergy in less than a month – Ragwitek developed by ALK-Abelló A/S of Denmark and partnered with Merck & Co Inc.
The US Food and Drug Administration has approved the second tablet therapy to treat hay fever in less than a month – this time an immunotherapy developed by ALK-Abelló A/S of Denmark, in partnership with Merck & Co Inc.
The US Food and Drug Administration has approved Tanzeum (albiglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist from GlaxoSmithKline Plc for Type 2 diabetes. The approval comes with a requirement for post-marketing studies.