Taliglucerase alfa regulatory update

Protalix submitted a reply to a February complete response letter from FDA for Gaucher's disease candidate taliglucerase alfa. The company expects to receive a new PDUFA date within weeks. The response includes additional data from a switchover trial and a long-term extension study, as well as CMC information (see BioCentury, Feb. 28). Pfizer has exclusive, worldwide rights to the plant cell-expressed recombinant form of human glucocerebrosidase (GCase) outside of Israel. ...