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.
The European Medicines Agency is considering revisions to its guideline on the evaluation of new anti-cancer agents in response to a growing number of new therapies, including vaccines and immunotherapies, that have entered clinical trials.
The US Food and Drug Administration has issued a final rule that clarifies what safety information must be reported by the developers of new investigational drugs and biologics during the clinical trials of these products.
The US Food and Drug Administration has approved a new combination oral contraceptive from Bayer Schering Pharma AG that contains a folate (levomefolate calcium), in order to protect against neural tube defects during a pregnancy.
The European Medicines Agency has recommended approval of Novartis’s vaccine for adults at risk of infection from H5N1, the subtype of the influenza A virus known as bird flu.
The European Medicines Agency has refused to grant a marketing authorisation for Merck Serono’s new small molecule drug for relapsing-remitting multiple sclerosis, Movectro (cladribine), citing concerns about the medicine’s safety.
A study of life-science start-ups in Britain over the five years to 2009 shows that investment per start-up in some regions is too small to ensure that the companies can be sustainable.
The US and Europe took divergent paths on Thursday in managing the risk of Avandia (rosiglitazone) even as drug regulators in both countries agreed that the cardiovascular risks associated with the medicine outweigh its benefits for patients with Type 2 diabetes.