Carbavance regulatory update

The Medicines Co. said FDA granted Qualified Infectious Disease Product (QIDP) designation for Carbavance in 6 indications, including complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP) and febrile neutropenia. The Medicines Co. plans to start Phase III testing this year for cUTIs and serious Gram-negative infections, with data expected in 2016. ...