Sigma Tau Aims For First FDA Approval Of Live Biotherapeutic
This article was originally published in Pharmaceutical Approvals Monthly
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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