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The European Medicines Agency Review of Kymriah (Tisagenlecleucel) for the Treatment of Acute Lymphoblastic Leukemia and Diffuse Large B-Cell Lymphoma.
Oncologist. 2020 Feb;25(2):e321-e327. doi: 10.1634/theoncologist.2019-0233. Epub 2019 Oct 16.
Oncologist. 2020.
PMID: 32043764
Free PMC article.
Review.
EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B-Cell Lymphoma.
Papadouli I, Mueller-Berghaus J, Beuneu C, Ali S, Hofner B, Petavy F, Tzogani K, Miermont A, Norga K, Kholmanskikh O, Leest T, Schuessler-Lenz M, Salmonson T, Gisselbrecht C, Garcia JL, Pignatti F.
Papadouli I, et al. Among authors: schuessler lenz m.
Oncologist. 2020 Oct;25(10):894-902. doi: 10.1634/theoncologist.2019-0646. Epub 2020 Apr 27.
Oncologist. 2020.
PMID: 32339368
Free PMC article.
Review.
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Marketing Regulatory Oversight of Advanced Therapy Medicinal Products in Europe.
Schuessler-Lenz M, Herberts C, Reischl I, Ruiz S, Celis P, Beuneu C, Kjeken R, Timón M.
Schuessler-Lenz M, et al.
Adv Exp Med Biol. 2023;1430:1-21. doi: 10.1007/978-3-031-34567-8_1.
Adv Exp Med Biol. 2023.
PMID: 37526839
Item in Clipboard
Regulators' Advice Can Make a Difference: European Medicines Agency Approval of Zynteglo for Beta Thalassemia.
Schuessler-Lenz M, Enzmann H, Vamvakas S.
Schuessler-Lenz M, et al.
Clin Pharmacol Ther. 2020 Mar;107(3):492-494. doi: 10.1002/cpt.1639. Epub 2019 Nov 8.
Clin Pharmacol Ther. 2020.
PMID: 31705534
Free PMC article.
No abstract available.
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Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.
Salmikangas P, Schuessler-Lenz M, Ruiz S, Celis P, Reischl I, Menezes-Ferreira M, Flory E, Renner M, Ferry N.
Salmikangas P, et al. Among authors: schuessler lenz m.
Adv Exp Med Biol. 2015;871:103-30. doi: 10.1007/978-3-319-18618-4_6.
Adv Exp Med Biol. 2015.
PMID: 26374215
Review.
Item in Clipboard
Regulatory Considerations for Clinical Trial Applications with CRISPR-Based Medicinal Products.
Anliker B, Childs L, Rau J, Renner M, Schüle S, Schuessler-Lenz M, Sebe A.
Anliker B, et al. Among authors: schuessler lenz m.
CRISPR J. 2022 Jun;5(3):364-376. doi: 10.1089/crispr.2021.0148. Epub 2022 Apr 22.
CRISPR J. 2022.
PMID: 35452274
Review.
Item in Clipboard
European regulation tackles tissue engineering.
Sanzenbacher R, Dwenger A, Schuessler-Lenz M, Cichutek K, Flory E.
Sanzenbacher R, et al. Among authors: schuessler lenz m.
Nat Biotechnol. 2007 Oct;25(10):1089-91. doi: 10.1038/nbt1007-1089.
Nat Biotechnol. 2007.
PMID: 17921987
No abstract available.
Item in Clipboard
Improving the efficacy of cancer immunotherapy.
Copier J, Dalgleish AG, Britten CM, Finke LH, Gaudernack G, Gnjatic S, Kallen K, Kiessling R, Schuessler-Lenz M, Singh H, Talmadge J, Zwierzina H, Håkansson L.
Copier J, et al. Among authors: schuessler lenz m.
Eur J Cancer. 2009 May;45(8):1424-31. doi: 10.1016/j.ejca.2008.12.017. Epub 2009 Jan 21.
Eur J Cancer. 2009.
PMID: 19167214
Review.
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