FDA to review Pharming's Ruconest for HAE

Pharming Group N.V. (Euronext:PHARM) and partner Santarus Inc. (NASDAQ:SNTS) said FDA accepted for review a resubmitted BLA for Ruconest conestat alfa to treat acute attacks of hereditary angioedema (HAE). The PDUFA date is April 16, 2014. The partners said FDA plans to hold a meeting of its Blood Products Advisory Committee to discuss Ruconest, but the meeting hasn't been scheduled. FDA refused to file a BLA for the product in 2011 (see BioCentury Extra, April 17). ...