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The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the committee for medicinal products for human use.
Pean E, Demolis P, Moreau A, Hemmings RJ, O'Connor D, Brown D, Shepard T, Abadie E, Pignatti F. Pean E, et al. Among authors: hemmings rj. Oncologist. 2012;17(4):543-9. doi: 10.1634/theoncologist.2011-0364. Epub 2012 Apr 3. Oncologist. 2012. PMID: 22477727 Free PMC article. Review.
The European medicines agency review of pomalidomide in combination with low-dose dexamethasone for the treatment of adult patients with multiple myeloma: summary of the scientific assessment of the committee for medicinal products for human use.
Hanaizi Z, Flores B, Hemmings R, Camarero J, Sancho-Lopez A, Salmonson T, Gisselbrecht C, Laane E, Pignatti F. Hanaizi Z, et al. Oncologist. 2015 Mar;20(3):329-34. doi: 10.1634/theoncologist.2014-0073. Epub 2015 Feb 11. Oncologist. 2015. PMID: 25673103 Free PMC article. Review.
The European medicines agency review of abiraterone for the treatment of metastatic castration-resistant prostate cancer in adult men after docetaxel chemotherapy and in chemotherapy-naive disease: summary of the scientific assessment of the committee for medicinal products for human use.
Gravanis I, Lopez AS, Hemmings RJ, Jiménez JC, Garcia-Carbonero R, Gallego IG, Giménez EV, O'Connor D, Giuliani R, Salmonson T, Pignatti F. Gravanis I, et al. Among authors: hemmings rj. Oncologist. 2013;18(9):1032-42. doi: 10.1634/theoncologist.2013-0092. Epub 2013 Aug 21. Oncologist. 2013. PMID: 23966222 Free PMC article.
The European Medicines Agency approval of ingenol mebutate (Picato) for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults: summary of the scientific assessment of the Committee for Medicinal Products for Human Use (CHMP).
Tzogani K, Nagercoil N, Hemmings RJ, Samir B, Gardette J, Demolis P, Salmonson T, Pignatti F. Tzogani K, et al. Among authors: hemmings rj. Eur J Dermatol. 2014 Jul-Aug;24(4):457-63. doi: 10.1684/ejd.2014.2368. Eur J Dermatol. 2014. PMID: 25115145
EMA Review of Daunorubicin and Cytarabine Encapsulated in Liposomes (Vyxeos, CPX-351) for the Treatment of Adults with Newly Diagnosed, Therapy-Related Acute Myeloid Leukemia or Acute Myeloid Leukemia with Myelodysplasia-Related Changes.
Tzogani K, Penttilä K, Lapveteläinen T, Hemmings R, Koenig J, Freire J, Márcia S, Cole S, Coppola P, Flores B, Barbachano Y, Roige SD, Pignatti F. Tzogani K, et al. Oncologist. 2020 Sep;25(9):e1414-e1420. doi: 10.1634/theoncologist.2019-0785. Epub 2020 Apr 13. Oncologist. 2020. PMID: 32282100 Free PMC article. Review.
Assessing the impact of ICH E9.
Brown D, Day S, Hemmings R, Wright D. Brown D, et al. Pharm Stat. 2008 Apr-Jun;7(2):77-87. doi: 10.1002/pst.337. Pharm Stat. 2008. PMID: 18438957
Extrapolation in the development of paediatric medicines: examples from approvals for biological treatments for paediatric chronic immune-mediated inflammatory diseases.
Stefanska AM, Distlerová D, Musaus J, Olski TM, Dunder K, Salmonson T, Mentzer D, Müller-Berghaus J, Hemmings R, Veselý R. Stefanska AM, et al. Arch Dis Child. 2017 Oct;102(10):952-957. doi: 10.1136/archdischild-2016-312259. Epub 2017 May 29. Arch Dis Child. 2017. PMID: 28554892 Review.
35 results