Regulatory evaluation of Glybera in Europe — two committees, one mission-Reference-Cited by-同舟云学术

Regulatory evaluation of Glybera in Europe — two committees, one mission

Published:2013-08-19 Issue:9 Volume:12 Page:719-719
ISSN:1474-1776
Container-title:Nature Reviews Drug Discovery
language:en
Short-container-title:Nat Rev Drug Discov

Author:

Melchiorri Daniela,Pani Luca,Gasparini Paolo,Cossu Giulio,Ancans Janis,Borg John Joseph,Drai Catherine,Fiedor Piotr,Flory Egbert,Hudson Ian,Leufkens Hubert G.,Müller-Berghaus Jan,Narayanan Gopalan,Neugebauer Brigitte,Pokrotnieks Juris,Robert Jean-Louis,Salmonson Tomas,Schneider Christian K.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology,General Medicine

Link

http://www.nature.com/articles/nrd3835-c1.pdf

Reference18 articles.

1. Flemming, A. Regulatory watch: pioneering gene therapy on brink of approval. Nature Rev. Drug Discov. 11, 664 (2012).

2. European Medicines Agency. European public assessment report (EPAR) for Glybera (alipogene tiparvovec). European Medicines Agency [online] , (2012).

3. European Medicines Agency. European Medicines Agency recommends first gene therapy for approval. European Medicines Agency [online] , (2012).

4. European Medicines Agency. Questions and answers: positive opinion on the marketing authorisation of Glybera (alipogene tiparvovec). European Medicines Agency [online] , (2012).

5. European Medicines Agency. Monthly report: Committee for Advanced Therapies October 2011 meeting. European Medicines Agency [online] , (2011).

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