Literature DB >> 22378026

The need for increased clarity and transparency in the regulatory pathway for gene medicines in the European Union.

Seppo Ylä-Herttuala.   

Abstract

Mesh:

Year:  2012        PMID: 22378026      PMCID: PMC3293610          DOI: 10.1038/mt.2012.14

Source DB:  PubMed          Journal:  Mol Ther        ISSN: 1525-0016            Impact factor:   11.454


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  5 in total

1.  Regulatory evaluation of Glybera in Europe - two committees, one mission.

Authors:  Daniela Melchiorri; Luca Pani; Paolo Gasparini; Giulio Cossu; Janis Ancans; John Joseph Borg; Catherine Drai; Piotr Fiedor; Egbert Flory; Ian Hudson; Hubert G Leufkens; Jan Müller-Berghaus; Gopalan Narayanan; Brigitte Neugebauer; Juris Pokrotnieks; Jean-Louis Robert; Tomas Salmonson; Christian K Schneider
Journal:  Nat Rev Drug Discov       Date:  2013-08-19       Impact factor: 84.694

2.  Propelling Healthcare with Advanced Therapy Medicinal Products: A Policy Discussion.

Authors:  Denis Horgan; Andres Metspalu; Marie-Christine Ouillade; Dimitrios Athanasiou; John Pasi; Oumeya Adjali; Patrick Harrison; Cedric Hermans; Giovanni Codacci-Pisanelli; Jasmina Koeva; Thomas Szucs; Viorica Cursaru; Ivica Belina; Chiara Bernini; Suijie Zhuang; Stephen McMahon; Draga Toncheva; Thomas Thum
Journal:  Biomed Hub       Date:  2020-12-03

3.  Endgame: glybera finally recommended for approval as the first gene therapy drug in the European union.

Authors:  Seppo Ylä-Herttuala
Journal:  Mol Ther       Date:  2012-10       Impact factor: 11.454

Review 4.  Technology forecast: advanced therapies in late clinical research, EMA approval or clinical application via hospital exemption.

Authors:  Claudia Eder; Claudia Wild
Journal:  J Mark Access Health Policy       Date:  2019-04-19

Review 5.  Accelerating Patients' Access to Advanced Therapies in the EU.

Authors:  Ahmed Elsanhoury; Ralf Sanzenbacher; Petra Reinke; Mohamed Abou-El-Enein
Journal:  Mol Ther Methods Clin Dev       Date:  2017-09-22       Impact factor: 6.698

  5 in total

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