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.
The US Food and Drug Administration has given the Novartis vaccine Bexsero, which is designed to protect against infection from meningococcal disease caused by serogroup B, a designation as a ‘breakthrough therapy’. This means it will receive an expedited review.
The US Food and Drug Administration has approved the first sublingual allergen extract for the treatment of hay fever which is induced by certain grass pollens. The product, Oralair, was developed by Stallergenes SA of France.
The US Food and Drug Administration has approved a new medicine for haemophilia B – the first treatment for the disorder to require less frequent injections. The drug, Alprolix, was developed by Biogen Idec Inc and Swedish Orphan Biovitrum AB.