FDA to fast-track review of firm's protein
September 4, 2007 04:04 PM
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GTC Biotherapeutics Inc. has won fast-track designation from federal regulators for ATryn, a protein produced in the milk of goats that has anticoagulant and anti-inflammatory properties.
The Framingham company is engaged in developing and producing human therapeutic proteins through transgenic technology.
According to GTC, fast-track designation by the Food and Drug Administration allows for an accelerated review process of ATryn as a treatment for patients with hereditary antithrombin deficiency who are at risk of developing deep vein thrombosis or thromboembolism while undergoing surgery or giving birth.
(By Chris Reidy, Globe staff)







