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Licensing of Orphan Medicinal Products-Use of Real-World Data and Other External Data on Efficacy Aspects in Marketing Authorization Applications Concluded at the European Medicines Agency Between 2019 and 2021.
Naumann-Winter F, Wolter F, Hermes U, Malikova E, Lilienthal N, Meier T, Kalland ME, Magrelli A. Naumann-Winter F, et al. Among authors: wolter f. Front Pharmacol. 2022 Aug 11;13:920336. doi: 10.3389/fphar.2022.920336. eCollection 2022. Front Pharmacol. 2022. PMID: 36034814 Free PMC article.
Assessment of significant benefit for orphan medicinal products by European regulators may support subsequent relative effectiveness assessments by health technology assessment organizations.
Vreman RA, de Ruijter AS, Zawada A, Tafuri G, Stoyanova-Beninska V, O'Connor D, Naumann-Winter F, Wolter F, Mantel-Teeuwisse AK, Leufkens HGM, Sidiropoulos I, Larsson K, Goettsch WG. Vreman RA, et al. Among authors: wolter f. Drug Discov Today. 2020 Jul;25(7):1223-1231. doi: 10.1016/j.drudis.2020.04.012. Epub 2020 Apr 25. Drug Discov Today. 2020. PMID: 32344040 Free article. Review.
A novel anti-HER2 anthracycline-based antibody-drug conjugate induces adaptive anti-tumor immunity and potentiates PD-1 blockade in breast cancer.
D'Amico L, Menzel U, Prummer M, Müller P, Buchi M, Kashyap A, Haessler U, Yermanos A, Gébleux R, Briendl M, Hell T, Wolter FI, Beerli RR, Truxova I, Radek Š, Vlajnic T, Grawunder U, Reddy S, Zippelius A. D'Amico L, et al. Among authors: wolter fi. J Immunother Cancer. 2019 Jan 21;7(1):16. doi: 10.1186/s40425-018-0464-1. J Immunother Cancer. 2019. PMID: 30665463 Free PMC article.
119 results