Back to School: How biopharma can reboot drug development. Access exclusive analysis here

Baby's breath

Developing compounds for pediatric indications usually entails additional safety and efficacy hurdles, which is why pediatric indications are seldom the basis for a compound's first approval. However, Discovery Laboratories Inc. and Stressgen Biotechnologies Inc., driven by the incentives of Orphan Designation, each plan to file for initial regulatory approval of their lead compounds in pediatric indications.

For DSCO, which is pursuing respiratory distress syndrome (RDS) in premature infants, the approval of three animal-derived surfactants over the last decade provides a clear regulatory path, yet leaves an unmet need based on supply and safety issues. For SSB, prodding by FDA to test its HspE7 in children and the resulting positive

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