BioCentury
ARTICLE | Regulation

Barnyard to bedside

January 19, 2009 8:00 AM UTC

The idea of genetically engineering cows, goats, rabbits and other mammals to turn them into protein factories probably is as old as the biotech industry itself, but after more than a quarter century of R&D, there are no "pharmed" drugs approved in the U.S.

FDA's Blood Products Advisory Committee's strong endorsement of ATryn, a recombinant antithrombin that GTC Biotherapeutics Inc. produces in transgenic goats, may provide the final push that brings the technology from the barnyard to American bedsides. The company now is awaiting the next step, as its BLA for ATryn to treat hereditary antithrombin deficiency has a Feb. 7 PDUFA deadline...