RHB-101 regulatory update

RedHill said it plans to submit an NDA to FDA and an MAA to EMA no earlier than 2H14 for RHB-101 to treat congestive heart failure and hypertension after it met with FDA to discuss the compound's regulatory path. The company plans to conduct additional CMC work before submitting the applications. As part of the NDA submission, the company will conduct a dose linearity study and a trial to compare the pharmacokinetics of RHB-101, a once-daily, controlled-release formulation of carvedilol, to Coreg CR carvedilol. No additional studies are required for the MAA, according to the company. ...