Ceftobiprole regulatory update

Basilea said it plans to submit an MAA to EMA next half for ceftobiprole to treat severe pneumonia in the hospital setting. The announcement follows an audit of 2 Phase III trials of the antibiotic to treat severe community-acquired and hospital-acquired pneumonia that did not identify compliance issues that "would compromise overall reliability" or "significantly impact primary outcomes." Following MAA submission, Basilea plans to hold a pre-NDA meeting with FDA to determine if an additional trial would be needed to support approval. ...