Re-examination of regulatory opinions in Europe: possible contribution for the approval of the first gene therapy product Glybera

The first commercially approved human gene therapy in the Western world is Glybera (alipogene tiparvovec), which is an adenoassociated viral vector encoding the lipoprotein lipase gene. Glybera was recommended for marketing authorization by the European Medicines Agency in 2012. The European Medicin...

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Detalles Bibliográficos
Autores principales: Watanabe, Natsumi, Yano, Kazuo, Tsuyuki, Kenichiro, Okano, Teruo, Yamato, Masayuki
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2015
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4449026/
https://www.ncbi.nlm.nih.gov/pubmed/26052534
http://dx.doi.org/10.1038/mtm.2014.66

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4449026/
https://www.ncbi.nlm.nih.gov/pubmed/26052534
http://dx.doi.org/10.1038/mtm.2014.66

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