Pharmaxis seeks re-examination of negative CHMP opinion for cystic fibrosis drug
This article was originally published in Scrip
Executive Summary
Pharmaxis is to file a re-examination request to challenge the European Medicines Agency's (EMA) recent refusal to grant a marketing authorisation for its cystic fibrosis therapy Bronchitol (inhaled mannitol), which is expected to result in the next EU decision on the orphan product around November.