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Daily Dose Newsletter

Wednesday
Mar212012

Surfactants in the News Again, FDA grants orphan status to Chiesi Pharma in the wake of Discovery Lab's Approval - $DSCO

According to the FDA's Orphan Drug product website, Chiesi Pharmaceuticals (an Italian-private pharma company) has been granted Orphan drug designation for 'Synthetic Surfactant Comprised Of Dppc, Popg Na, Synthetic Sp-C Analogue And Synthetic Sp-B Analogue' for the treatment of preterm neonatal respiratory distress syndrome (RDS). Recall that the FDA recently approved Discover Labs ($DSCO) synthetic surfactant too (aka: Surfaxin).

Chiesi currently has an approved animal-sourced product for neonatal RDS, Curosurf; this new orphan designation is specifically for a synthetic drug candidate.  The companies previously approved products include Curosurf  (all are animal-sourced products).  In the US, Cornerstone Therapeutics ($CRTX) has  marketing rights.

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