NetworkNewsBreaks – Aeterna Zentaris, Inc. (NASDAQ: AEZS) Receives EMA Pediatric Committee Agreement on PIP for Macrilen™
Shares of Aeterna Zentaris (NASDAQ: AEZS) are 6% higher in morning trade after the company said the European Medicines Agency’s (EMA) Pediatric Committee (PDCO) has agreed to the company’s Pediatric Investigation Plan (PIP) for Macrilen™. PDCO also agreed that Aeterna may defer conducting the PIP until after it files a Marketing Authorization Application (MAA) for the use of Macrilen™ for the evaluation of adult growth hormone deficiency. “PDCO’s agreement that we may defer conducting our PIP, allowing us to go forward with an MAA in adults prior to initiating of the pediatric development program, is an important step forward in…