FDA asks NicOx for new naproxcinod trial

The FDA has issued a complete response letter asking NicOx to conduct another clinical trial of naproxcinod, a treatment for osteoarthritis. Earlier, an expert panel had voted 16 to 1 against the drug, saying that the French biotech had not offered solid evidence to prove that its painkiller did not raise blood pressure. Concerned about cardiovascular and gastrointestinal side effects of the drug, the agency has recommended that NicOx conduct one or more long-term controlled...

FDA rejects AstraZeneca’s Axanum

The FDA has declined to approve AstraZeneca's (NYSE: AZN) Axanum, a combination of aspirin and esomeprazole, the main ingredient in the blockbuster drug Nexium. The drug is an experimental treatment for the prevention of ulcers. Additionally, the FDA issued a complete response letter for Nexium for reducing the risk of low-dose aspirin-associated peptic ulcers. It's a setback for AstraZeneca, which is attempting to extend Nexium's usage before the $5 billion-a-year drug...