The US Food and Drug Administration has approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with atrial fibrillation. The product has been developed by Boehringer Ingelheim GmbH.
Eli Lilly and Co, Amylin Pharmaceuticals Inc and Alkermes Inc have received a ‘complete response letter’ from the US Food and Drug Administration for Bydureon which is intended to improve glycemic control for adults with Type 2 diabetes.
Genmab A/S said that, based on discussions with regulators, it has sufficient data to file a marketing authorisation application in Europe for zalutumumab for the second-line treatment of patients with head and neck cancer.
The US Food and Drug Administration has approved the use of Botox (onabotulinumtoxinA) to prevent headaches in adults with chronic migraine. This is the newest indication for a product that was first approved for eye muscle disorders.
The European Medicines Agency has adopted new conflict-of-interest rules for the experts that advise its scientific committees. In future, declarations from the agency’s experts will be published on the EMA website.
The US Food and Drug Administration has issued a warning about the possible risk of atypical thigh bone fracture in patients who take bisphosphonates which are used to prevent and treat osteoporosis. Manufactures are being asked to alter their labels.
Merck Serono has announced plans to appeal against the European Medicines Agency’s decision not to recommend approval of its candidate multiple sclerosis drug, Movectro (cladribine). The negative opinion was issue on 23 September 2010.
At the request of the US Food and Drug Administration, Abbott Laboratories Inc has agreed to withdraw its obesity drug, Meridia (sibutramine), from the US market because of clinical trial data indicating an increased cardiovascular risk.
Boehringer Ingelheim has decided to discontinue development of flibanserin, its compound for hypoactive sexual desire disorder in pre-menopausal women, following its rejection by the US Food and Drug Administration.
The US Food and Drug Administration has awarded $2.9 million to support six research projects aimed at helping with the diagnosis, treatment and prevention of tuberculosis. The awards were issued under the agency’s Critical Path Initiative.