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.
AstraZeneca Plc said its candidate drug for thyroid cancer, vandetanib, has been given priority review status by the US Food and Drug Administration which means a decision on marketing should be taken in six months instead of the usual ten.
The US Food and Drug Administration has approved Gilenya (fingolimod), Novartis’s oral, first-line treatment for relapsing multiple sclerosis. It is the first oral therapy for relapsing forms of MS to be approved in the US, the company said.
An advisory committee of the US Food and Drug Administration has voted to recommend approval of Boehringer Ingelheim’s drug for the prevention of stroke in patients with atrial fibrillation. The vote to recommend was nine to zero.