Novartis Revises U.S. Regulatory Strategy For Key Respiratory Drug

The Swiss drug maker says it has agreed with FDA on a Phase III trial design for the combination respiratory drug QVA149 and expects to file in late 2014; plan now calls for testing a twice-daily dose in addition to once-daily.

An important drug in Novartis AG’s respiratory pipeline has been sidelined in the U.S. by FDA’s crackdown on the safety of long-acting beta2-adrenergic agonists, but during a first quarter sales and earnings conference call April 24, management said it has made progress on the regulatory strategy for QVA149.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

More from R&D