Sigma Tau Aims For First FDA Approval Of Live Biotherapeutic
This article was originally published in The Pink Sheet Daily
Executive Summary
Subsidiary of Italian specialty firm is seeking to develop a biologic containing live microorganisms to prevent necrotizing enterocolitis, the most common GI complication in very low birth weight premature infants. Sigma-Tau had to write an IND without any existing FDA guidance and faces numerous complications both due to the pioneering nature of its work and the high-risk status of its trial subjects.
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