Investigators looking to develop new therapies for children with Gaucher disease may use either multi-company, multi-arm clinical trials or data extrapolation techniques, according the FDA and European Medicines Agency. Read More

UK drug giant GlaxoSmithKline said Tuesday that its investigational coronary drug darapladib failed to reduce cardiovascular events in patients experiencing symptoms of obstructed blood flow to the heart, marking another setback for the once promising therapy. Read More

A new Citizen Petition contends the FDA should revoke Ranbaxy’s first-to-file market exclusivity status on several lucrative generic drugs due to a clear history of manufacturing problems and intentional false statements made by the Indian generics company. Read More

The UK’s Medicines and Healthcare products Regulatory Agency is now accepting applications for its Early Access to Medicines Scheme, which allows drugs for life-threatening diseases to be approved on an interim basis and made available to patients sooner. Read More

European regulators are urging manufacturers of biosimilar insulin-containing products to demonstrate similar pharmacokinetic and pharmacodynamic (PD) profiles as the gold standard in proving efficacy similarity to the reference products. Read More

The FDA’s top drug official slammed the current clinical trial system as a major barrier to rapid drug development and urged the drug industry to adopt clinical trial networks as a better way to evaluate new products. Read More