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Literature DB >> 23954897

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

Daniela Melchiorri¹, 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.

Abstract

Mesh：

Year: 2013 PMID： 23954897 DOI： 10.1038/nrd3835-c1

Source DB: PubMed Journal: Nat Rev Drug Discov ISSN： 1474-1776 Impact factor: 84.694

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5 in total

1. Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive.

Authors: Romaldas Maciulaitis; Lucia D'Apote; Andrew Buchanan; Laura Pioppo; Christian K Schneider
Journal: Mol Ther Date: 2012-03 Impact factor: 11.454

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

Authors: Seppo Ylä-Herttuala
Journal: Mol Ther Date: 2012-03 Impact factor: 11.454

3. Glybera and the future of gene therapy in the European Union.

Authors: Norman Miller
Journal: Nat Rev Drug Discov Date: 2012-05 Impact factor: 84.694

4. Agency defies advice and rejects gene therapy for third time.

Authors: Nuala Moran
Journal: Nat Biotechnol Date: 2012-06-07 Impact factor: 54.908

5. Regulatory watch: pioneering gene therapy on brink of approval.

Authors: Alexandra Flemming
Journal: Nat Rev Drug Discov Date: 2012-09 Impact factor: 84.694

5 in total

19 in total

Review 1. Virotherapy: cancer gene therapy at last?

Authors: Alan E Bilsland; Pavlina Spiliopoulou; T R Jeffry Evans
Journal: F1000Res Date: 2016-08-30

Review 2. Mouse models in hematopoietic stem cell gene therapy and genome editing.

Authors: Stefan Radtke; Olivier Humbert; Hans-Peter Kiem
Journal: Biochem Pharmacol Date: 2019-11-06 Impact factor: 5.858

Review 3. Clinical applications involving CNS gene transfer.

Authors: Boris Kantor; Thomas McCown; Paola Leone; Steven J Gray
Journal: Adv Genet Date: 2014 Impact factor: 1.944

Review 4. Antibiotic-free selection in biotherapeutics: now and forever.

Authors: Charlotte Mignon; Régis Sodoyer; Bettina Werle
Journal: Pathogens Date: 2015-04-03

5. Selective in vivo targeting of human liver tumors by optimized AAV3 vectors in a murine xenograft model.

Authors: Chen Ling; Yuan Wang; Yuanhui Zhang; Anila Ejjigani; Zifei Yin; Yuan Lu; Lina Wang; Meng Wang; Jun Li; Zhongbo Hu; George V Aslanidi; Li Zhong; Guangping Gao; Arun Srivastava; Changquan Ling
Journal: Hum Gene Ther Date: 2014-12 Impact factor: 5.695

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

1. Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive.

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

3. Glybera and the future of gene therapy in the European Union.

4. Agency defies advice and rejects gene therapy for third time.

5. Regulatory watch: pioneering gene therapy on brink of approval.

Review 1. Virotherapy: cancer gene therapy at last?

Review 2. Mouse models in hematopoietic stem cell gene therapy and genome editing.

Review 3. Clinical applications involving CNS gene transfer.

Review 4. Antibiotic-free selection in biotherapeutics: now and forever.

5. Selective in vivo targeting of human liver tumors by optimized AAV3 vectors in a murine xenograft model.

Review 6. Antilipidemic Drug Therapy Today and in the Future.

7. Dystrophin Gene Replacement and Gene Repair Therapy for Duchenne Muscular Dystrophy in 2016: An Interview.

Review 8. Gene therapy returns to centre stage.

9. Gene therapy for GM1 gangliosidosis: challenges of translational medicine.

10. Gene therapy for the treatment of catecholaminergic polymorphic ventricular tachycardia.