Monday, October 1, 2012

Endgame: Glybera Finally Recommended for Approval as the First Gene Therapy Drug in the European Union

Endgame: Glybera Finally Recommended for Approval as the First Gene Therapy Drug in the European Union; Seppo Ylä-Herttuala. Molecular Therapy (2012); 20 10, 1831–1832. doi:10.1038/mt.2012.194

Editorial-full text

Despite these problems and difficulties, the final opinion in favor of Glybera is encouraging news for the gene and cell therapy communities, and hopefully evaluation of the twists and turns of the plot of this saga will help to streamline the regulatory processes of other gene and cell therapy products so that this new area of medicine can eventually fulfill its promise in human medicine