- Ali S, Camarero J, Hennik P, Bolstad B, Sommerfelt Grønvold M, Syvertsen C, Oddvar Strøm B, Ökvist M, Josephson F, Keller-Stanislawski B, Zafiropoulos N, Pean E, Bergh J, da Rocha Dias S, Pignatti F. European Medicines Agency extension of indication to include the combination immunotherapy cancer drug treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) for adults with intermediate/poor-risk advanced renal cell carcinoma. ESMO Open. 2020 Nov;5(6):e000798.
- Althunian TA, de Boer A, Groenwold RHH, Rengerink KO, Souverein PC, Klungel OH. Rivaroxaban was found to be noninferior to warfarin in routine clinical care: A retrospective noninferiority cohort replication study. Pharmacoepidemiol Drug Saf. 2020 Oct;29(10):1263-1272.
- Barbier L, Ebbers HC, Declerck P, Simoens S, Vulto AG, Huys I. The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review. Clin Pharmacol Ther. 2020 Oct;108(4):734-755.
- Bernabe RDLC, van Thiel GJMW, Breekveldt NS, Gispen CC, van Delden JJM. Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization? BMC Med Ethics. 2020 Oct 27;21(1):103.
- Cavaleri M, Enzmann H, Straus S, Cooke E. The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines. Lancet. 2021 Jan 30;397(10272):355-357.
- Delgado J, Josephson F, Camarero J, Garcia-Ochoa B, Lopez-Anglada L, Prieto-Fernandez C, van Hennik PB, Papadouli I, Gisselbrecht C, Enzmann H, Pignatti F. EMA Review of Acalabrutinib for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia. Oncologist. 2021 Jan 23.
- Heusinkveld H, Braakhuis H, Gommans R, Botham P, Corvaro M, van der Laan JW, Lewis D, Madia F, Manou I, Schorsch F, Wolterink G, Woutersen R, Corvi R, Mehta J, Luijten M. Towards a mechanism-based approach for the prediction of nongenotoxic carcinogenic potential of agrochemicals. Crit Rev Toxicol. 2020 Oct;50(9):725-739.
- Hoeve CE, de Vries E, Mol PGM, Sturkenboom MCJM, Straus SMJM. Dissemination of Direct Healthcare Professional Communications on Medication Errors for Medicinal Products in the EU: An Explorative Study on Relevant Factors. Drug Saf. 2021 Jan;44(1):73-82.
- Houwen JPA, Egberts ACG, de Boer A, van Maarseveen EM, Houwen RHJ, Lalmohamed A. Influence of allopurinol on thiopurine associated toxicity: A retrospective population-based cohort study. Br J Clin Pharmacol. 2020 Oct 28.
- Ismail RK, Sikkes NO, Wouters MWJM, Hilarius DL, Pasmooij AMG, van den Eertwegh AJM, Aarts MJB, van den Berkmortel FWPJ, Boers-Sonderen MJ, de Groot JWB, Haanen JBAG, Hospers GAP, Kapiteijn E, Piersma D, van Rijn RS, Suijkerbuijk KPM, Ten Tije BJ, van der Veldt AAM, Vreugdenhil A, van Dartel M, de Boer A. Postapproval trials versus patient registries: comparability of advanced melanoma patients with brain metastases. Melanoma Res. 2021 Feb 1;31(1):58-66.
- Kurz X, Arlett P, Eichler HG, Nolte A, Straus S, Rasi G. Increasing the impact of Post Authorisation Safety Studies: transparency is key. Eur J Intern Med. 2021 Jan;83:6-7.
- Luijten M, Corvi R, Mehta J, Corvaro M, Delrue N, Felter S, Haas B, Hewitt NJ, Hilton G, Holmes T, Jacobs MN, Jacobs A, Lamplmair F, Lewis D, Madia F, Manou I, Melching-Kollmuss S, Schorsch F, Schütte K, Sewell F, Strupp C, van der Laan JW, Wolf DC, Wolterink G, Woutersen R, Zvonar Z, Heusinkveld H, Braakhuis H. A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals. Regul Toxicol Pharmacol. 2020 Dec;118:104789.
- Minnema LA, Giezen TJ, Hoekman J, Egberts TCG, Leufkens HGM, Gardarsdottir H. Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF-α Inhibitors. Clin Pharmacol Ther. 2020 Dec 5.
- Mulder J, Pasmooij AMG, Stoyanova-Beninska VV, Schellens JHM. Breakthrough therapy-designated oncology drugs: are they rightfully criticized? Drug Discov Today. 2020 Sep;25(9):1580-1584.
- Opalska A, Kwa M, Leufkens H, Gardarsdottir H. Enabling appropriate use of antibiotics: review of European Union procedures of harmonising product information, 2007 to 2020. Euro Surveill. 2020 Nov;25(45):2000035.
- Rovida C, Escher SE, Herzler M, Bennekou SH, Kamp H, Kroese DE, Maslankiewicz L, Moné MJ, Patlewicz G, Sipes N, Van Aerts L, White A, Yamada T, Van de Water B. NAM-supported read-across: From case studies to regulatory guidance in safety assessment. ALTEX. 2021;38(1):140-150.
- Starokozhko V, Kallio M, Kumlin Howell Å, Mäkinen Salmi A, Andrew-Nielsen G, Goldammer M, Burggraf M, Löbker W, Böhmer A, Agricola E, de Vries CS, Pasmooij AMG, Mol PGM; STARS consortium. Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap. Drug Discov Today. 2020 Oct 27:S1359-6446(20)30434-7.
- Ten Ham RMT, Nievaart JC, Hoekman J, Cooper RS, Frederix GWJ, Leufkens HGM, Klungel OH, Ovelgönne H, Hoefnagel MHN, Turner ML, Mountford JC. Estimation of manufacturing development costs of cell-based therapies: a feasibility study. Cytotherapy. 2021 Feb 13:S1465-3249(21)00004-9.
- Vreman RA, Bloem LT, van Oirschot S, Hoekman J, van der Elst ME, Leufkens HG, Klungel OH, Goettsch WG, Mantel-Teeuwisse AK. The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs. Int J Health Policy Manag. 2020 Oct 27.
This article is part of: Regulatory Science Edition 12