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A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making
Coppens, D. G. M., de Wilde, S., Guchelaar, H. J., De Bruin, M. L., Leufkens, H. G. M., Meij, P. & Hoekman, J., 2018, In: Cytotherapy. 20, 6, p. 769-778 10 p.Research output: Contribution to journal › Journal article › Research › peer-review
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Global Regulatory Differences for Gene- and Cell-Based Therapies: Consequences and Implications for Patient Access and Therapeutic Innovation
Coppens, D. G. M., De Bruin, M. L., Leufkens, H. G. M. & Hoekman, J., Jan 2018, In: Clinical Pharmacology and Therapeutics. 103, p. 120-127Research output: Contribution to journal › Review › Research › peer-review
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Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries
Coppens, D. G. M., Gardarsdottir, H., De Bruin, M. L., Meij, P., Leufkens, H. G. M. & Hoekman, J., Aug 2020, In: Regenerative Medicine. 15, 8, p. 2015-2028 14 p.Research output: Contribution to journal › Journal article › Research › peer-review
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A decade of marketing approval of gene and cell based therapies in the United States, European Union, and Japan: A regulatory decision-making evaluation
Coppens, D. G. M., de Wilde, S., Guchelaar, H. J., De Bruin, M. L., Leufkens, H. G. M., Meij, P. & Hoekman, J., 2018, In: Pharmacoepidemiology and Drug Safety. 27, S2, p. 517-517Research output: Contribution to journal › Conference abstract in journal › Research › peer-review
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Publication rates and reported results in a cohort of gene-and cell-based therapy trials
Coppens, D. G. M., Gardarsdottir, H., Van Den Bogert, C. A., De Bruin, M. L., Leufkens, H. G. M. & Hoekman, J., 2020, In: Regenerative Medicine. 15, 1, p. 1215-1227 13 p.Research output: Contribution to journal › Journal article › Research › peer-review
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Impact of European Benefit-Risk reassessment procedures on drug prescribing practices in Denmark
De Bruin, M. L. (., Hallgreen, Christine Erikstrup & Andersen, Morten, Aug 2019.Research output: Contribution to conference › Conference abstract for conference › Research › peer-review
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A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways
Druedahl, Louise C., Almarsdóttir, Anna Birna, Kälvemark Sporrong, Sofia, De Bruin, M. L., Hoogland, H., Minssen, Timo, van de Weert, Marco, Kesselheim, A. S. & Sarpatwari, A., 2020, In: Nature Biotechnology. 38, 11, p. 1253-1256 4 p.Research output: Contribution to journal › Journal article › Research › peer-review
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Evolving biosimilar clinical requirements: A qualitative interview study with industry experts and European national medicines agency regulators
Druedahl, Louise C., Kälvemark Sporrong, Sofia, van de Weert, Marco, De Bruin, M. L. (., Hoogland, H., Minssen, Timo & Almarsdóttir, Anna Birna, 2021, In: BioDrugs. 35, p. 351-361Research output: Contribution to journal › Journal article › Research › peer-review
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MEDICINES AUTHORITY REGULATOR AND INDUSTRY PERCEPTIONS OF BIOSIMILAR INTERCHANGEABILITY
Druedahl, Louise C., De Bruin, M. L., Hoogland, H., Minssen, Timo, van de Weert, Marco, Kälvemark Sporrong, Sofia & Almarsdóttir, Anna Birna, Dec 2019, p. E45-E46.Research output: Contribution to conference › Conference abstract for conference › Research › peer-review
- Published
ELSI Implications of Prioritizing Biological Therapies in the Times of COVID-19
Druedahl, Louise C., Lebret, Audrey & Minssen, Timo, Oct 2020, In: Journal of Law, Medicine & Ethics. 48, 3, p. 579-582Research output: Contribution to journal › Journal article › Research › peer-review
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Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness
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237
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MEDICINES AUTHORITY REGULATOR AND INDUSTRY PERCEPTIONS OF BIOSIMILAR INTERCHANGEABILITY
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Cancer risk among insulin users: comparing analogues with human insulin in the CARING five-country cohort study
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Medicines safety information from regulators in clinical practice guidelines: a mixed-method case study
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