The FDA has given a complete response letter to Israel-based Protalix Biotherapeutics for the company’s application for marketing approval of an protein therapy for Gaucher’s disease, the firm announced this morning. Cambridge, MA-based Genzyme currently has the best selling treatment for Gaucher’s disease, which is a rare genetic disorder that causes a fatty substance to build up in cells and organs. Protalix, which partnered with Pfizer in November 2009 to develop its Gaucher’s treatment, taliglucerase alfa, said that the FDA could not approve its drug at this time because of the agency’s questions about clinical matters, chemistry, manufacturing, and controls related to the product.
Author: Ryan McBride
Ryan is an award-winning business journalist who contributes to our life sciences and technology coverage. He was previously a staff writer for Mass High Tech, a Boston business and technology newspaper, where he and his colleagues won a national business journalism award from the Society of American Business Editors and Writers in 2008. In recent years, he has made regular TV appearances on New England Cable News.
Prior to MHT, Ryan covered the life sciences, technology, and energy sectors for Providence Business News. He graduated with honors from the University of Rhode Island in 2001 with a bachelor’s degree in communications. When he’s not chasing down news, Ryan enjoys mountain biking and skiing in his home state of Vermont.
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