Publications by authors named "Francesco Pignatti"

59Publications

Revocation of the conditional marketing authorisation of a cancer medicine: The olaratumab experience.

Eur J Cancer 2019 12 23;123:25-27. Epub 2019 Oct 23.

European Medicines Agency, the Netherlands. Electronic address:

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http://dx.doi.org/10.1016/j.ejca.2019.09.020DOI Listing
December 2019

From Individual to Population Preferences: Comparison of Discrete Choice and Dirichlet Models for Treatment Benefit-Risk Tradeoffs.

Med Decis Making 2019 10 9;39(7):879-885. Epub 2019 Sep 9.

Department of Epidemiology, University of Groningen, University Medical Center Groningen, the Netherlands.

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http://dx.doi.org/10.1177/0272989X19873630DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6843605PMC
October 2019

Quantifying Preferences in Drug Benefit-Risk Decisions.

Clin Pharmacol Ther 2019 11 24;106(5):955-959. Epub 2019 Apr 24.

Department of Management, London School of Economics and Political Science, London, UK.

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https://onlinelibrary.wiley.com/doi/abs/10.1002/cpt.1447
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http://dx.doi.org/10.1002/cpt.1447DOI Listing
November 2019

Regulatory and Evidence Requirements and the Changing Landscape in Regulation for Marketing Authorisation.

Recent Results Cancer Res 2019;213:169-187

European Medicines Agency, 30 Churchill Place, Canary Wharf, London, UK.

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http://link.springer.com/10.1007/978-3-030-01207-6_11
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http://dx.doi.org/10.1007/978-3-030-01207-6_11DOI Listing
May 2019

Assessment of medical devices: the Emperor's new clothes: Author reply.

Br J Radiol 2018 06 11;91(1086):20180310. Epub 2018 May 11.

7 European Medicines Agency , London , UK.

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http://dx.doi.org/10.1259/bjr.20180310DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223301PMC
June 2018

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.

Oncologist 2015 Mar 11;20(3):329-34. Epub 2015 Feb 11.

European Medicines Agency, London, United Kingdom; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain; Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; Hôpital Saint Louis, Paris, France; North Estonia Regional Hospital, Tallinn, Estonia.

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http://theoncologist.alphamedpress.org/content/20/3/329.full
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http://theoncologist.alphamedpress.org/cgi/doi/10.1634/theon
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http://dx.doi.org/10.1634/theoncologist.2014-0073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4350811PMC
March 2015

The European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine: summary of the scientific assessment of the committee for medicinal products for human use.

Oncologist 2015 Feb 23;20(2):196-201. Epub 2015 Jan 23.

European Medicines Agency, London, United Kingdom; Statens Legemiddelverk, Norwegian Medicines Agency, Oslo, Norway; Lægemiddelstyrelsen, Danish Health and Medicines Authority, København, Denmark; Läkemedelsverket, Medicinal Products Agency, Uppsala, Sweden; Universitair Ziekenhuis, Ghent, Belgium; European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium; Centrum für Operative Urologie Bremen, Bremen, Germany; Karolinska Institute and Hospital, Stockholm, Sweden.

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http://theoncologist.alphamedpress.org/cgi/doi/10.1634/theon
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http://dx.doi.org/10.1634/theoncologist.2014-0177DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4319625PMC
February 2015

The European Medicines Agency Review of Pertuzumab for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer: summary of the scientific assessment of the committee for medicinal products for human use.

Oncologist 2014 Jul 13;19(7):766-73. Epub 2014 Jun 13.

European Medicines Agency, London, United Kingdom; Danish Health and Medicines Authority, København, Denmark; Department of Physiology and Pharmacology, Università di Roma "La Sapienza," Rome, Italy; Agenzia Italiana del Farmaco, Rome, Italy; Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; Karolinska Institutet, Stockholm, Sweden; The Netherlands Cancer Institute, Amsterdam, The Netherlands.

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http://dx.doi.org/10.1634/theoncologist.2013-0348DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4077440PMC
July 2014

The European medicines agency review of bosutinib for the treatment of adult patients with chronic myelogenous leukemia: summary of the scientific assessment of the committee for medicinal products for human use.

Oncologist 2014 Apr 25;19(4):421-5. Epub 2014 Mar 25.

European Medicines Agency, London, United Kingdom; Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany; Agencia Española de Medicamentos y Productos Sanitarios, Servicio de Farmacología Clínica, Hospital Puerta de Hierro, Madrid, Spain; Läkemedelsverket, Medical Products Agency, Uppsala, Sweden; Hôpital Saint Louis, Paris, France; North Estonia Regional Hospital, Tallinn, Estonia.

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http://dx.doi.org/10.1634/theoncologist.2013-0294DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3983815PMC
April 2014

Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union.

Clin Cancer Res 2014 Mar;20(6):1458-68

Authors' Affiliations: The European Medicines Agency; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom; Medical Products Agency, Uppsala, Sweden; Paul-Ehrlich-Institut, Langen, Germany; and Medical University of Vienna, Vienna, Austria.

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http://dx.doi.org/10.1158/1078-0432.CCR-13-1571DOI Listing
March 2014

Access to patient-level trial data--a boon to drug developers.

N Engl J Med 2013 Oct 21;369(17):1577-9. Epub 2013 Oct 21.

From the European Medicines Agency, London.

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http://dx.doi.org/10.1056/NEJMp1310771DOI Listing
October 2013

Platelet response as the basis for approval in chronic immune (idiopathic) thrombocytopenic purpura (ITP): a regulatory perspective.

Am J Hematol 2012 Oct 17;87(10):943-4. Epub 2012 Sep 17.

European Medicines Agency, London, United Kingdom.

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http://dx.doi.org/10.1002/ajh.23300DOI Listing
October 2012

Regulators, payers, and prescribers: can we fill the gaps?

Lancet Oncol 2011 Sep;12(10):930-1

European Medicines Agency, London, UK.

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https://linkinghub.elsevier.com/retrieve/pii/S14702045117022
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http://dx.doi.org/10.1016/S1470-2045(11)70229-7DOI Listing
September 2011

Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma.

Nat Rev Drug Discov 2008 Oct 12;7(10):818-26. Epub 2008 Sep 12.

European Medicines Agency, Canary Wharf, London, UK.

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http://dx.doi.org/10.1038/nrd2664DOI Listing
October 2008

Overview of the European regulatory approval system.

J Ambul Care Manage 2004 Apr-Jun;27(2):89-97

European Agency for the Evaluation of Medicinal Products (EMEA), Canary Wharf, London, United Kingdom.

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http://dx.doi.org/10.1097/00004479-200404000-00003DOI Listing
April 2004

The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome.

Eur J Clin Pharmacol 2002 Dec 13;58(9):573-80. Epub 2002 Nov 13.

Safety and Efficacy, Oncology, European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK.

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http://link.springer.com/10.1007/s00228-002-0532-8
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http://dx.doi.org/10.1007/s00228-002-0532-8DOI Listing
December 2002

Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology.

Crit Rev Oncol Hematol 2002 May;42(2):123-35

The European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK.

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http://dx.doi.org/10.1016/s1040-8428(02)00009-4DOI Listing
May 2002