Discovery Labs Admits Pricing For Long-Awaited Surfaxin Will Be Tricky
Executive Summary
Surfaxin, a synthetic alternative to animal-derived products for respiratory distress syndrome, deserves a premium, say execs, but company’s main goal is to get top spot on hospital formularies in competition with low-cost rivals.
You may also be interested in...
For Discovery’s Surfaxin, Another Delay
Discovery Labs delays the commercial launch of its RDS drug Surfaxin until 2Q 2013, but continues to look for an international partner for the rest of its pipeline. The company assures investors that the delay is not indicative or safety or efficacy problems.
Settling In To The “New Normal”: Midway Through 2012, Another Banner Year For Drug Approvals Is Within Reach
The forecast for 2012 approvals looks sunny. FDA approved almost as many novel drugs in the first half of 2012 as it did in the first half of its record-breaking 2011 – and the agency has more than twice as many pending NME applications with user fee goals in the next six months as it had last year.
Will March 2012 Mark The End Of Regulatory Limbo For Discovery's Surfaxin?
FDA has set a March 6 user fee date for action on Discovery Laboratories' synthetic surfactant, which was filed with the agency in 2004 but is now in its fifth review cycle.