The US Food and Drug Administration has approved Brilinta (ticagrelor), an oral antiplatelet medicine, to reduce the rate of cardiovascular death and heart attack in adult patients with acute coronary syndrome. The developer is AstraZeneca Plc.
A panel of the US Food and Drug and Administration voted narrowly not to recommend the approval of a first-in-class therapy developed by Bristol-Myers Squibb Company and Astra-Zeneca Plc for diabetes.
Pfizer Ltd has withdrawn an application from the European Medicines Agency to extend the indication of its eye medicine, Macugen (pegaptanib sodium) to include the treatment of visual impairment due to diabetic macular oedema, the EMA said.
The US Food and Drug Administration has approved a new indication for the ulcerative colitis drug, Lialda (mesalamine), for the maintenance of remission in patients with the disease, according to the drug’s sponsor, Shire Plc.
The US Food and Drug Administration has issued a draft guidance for companies that are developing diagnostic tests intended to be used with targeted drug therapies. The document gives the agency’s approach towards the review of these products.
The European Medicines Agency said it is reviewing the cardiovascular risk of the anti-arrhythmic medicine, Multaq (dronedarone) from Sanofi SA, following the company’s announcement on 7 July that it was halting a Phase 3b trial of the drug.
The US Food and Drug Administration has approved the Boostrix vaccine, currently available for adolescents and adults, for use in people 65 years and older for the prevention of tetanus, diphtheria and pertussis.
In separate announcements, Novartis AG said that its bronchodilator for chronic obstructive pulmonary disease, indacaterol, has been approved by regulatory authorities in the US and Japan. The drug is a long-acting beta2-agonist.
The US Food and Drug Administration has approved a new anticoagulant for the prevention of deep vein thrombosis in patients undergoing knee or hip replacement surgery, according to the drug’s manufacturer, Janssen Pharmaceuticals Inc.
The Japanese regulator has approved a rotavirus vaccine developed by GlaxoSmithKline Plc to prevent gastroenteritis caused by rotavirus in infants. The vaccine contains a live, attenuated form of the human rotavirus, RIX4414 strain.