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The US Food and Drug Administration has issued a draft guidance for companies that are developing diagnostic tests intended to be used with targeted drug therapies.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.
Amsterdam Molecular Therapeutics Holding NV is to appeal against a negative opinion issued by the European Medicines Agency for its gene therapy to treat a protein deficiency linked to pancreatitis. The opinion was issued on 23 June 2011.
Nexium (esomeprazole magnesium), a treatment for acid-related conditions of the stomach, has received its first regulatory approval in Japan, according to AstraZeneca Plc, the drug’s developer. The approval is for use in adult patients.
An advisory panel to the US Food and Drug Administration has endorsed the agency’s decision in late 2010 to remove the breast cancer indication for Avastin (bevacizumab) despite strenuous objections from the drug’s manufacturer, Roche.