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Items: 1 to 50 of 62

1.

EMA Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple Myeloma.

Tzogani K, Hennik PV, Walsh I, De Graeff P, Folin A, Sjöberg J, Salmonson T, Bergh J, Laane E, Ludwig H, Gisselbrecht C, Pignatti F.

Oncologist. 2018 Jul;23(7):870. doi: 10.1634/theoncologist.2017-0301erratum. No abstract available.

2.

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

Sharma RA, Fumi L, Audisio RA, Denys A, Wood BJ, Pignatti F.

Br J Radiol. 2018 Jun;91(1086):20180310. doi: 10.1259/bjr.20180310. Epub 2018 May 11. No abstract available.

PMID:
29688753
3.

Effectiveness of integrated care model for type 2 diabetes: A population-based study in Reggio Emilia (Italy).

Ballotari P, Venturelli F, Manicardi V, Ferrari F, Vicentini M, Greci M, Pignatti F, Storani S, Giorgi Rossi P.

PLoS One. 2018 Mar 27;13(3):e0194784. doi: 10.1371/journal.pone.0194784. eCollection 2018.

4.

EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma.

Tzogani K, Penninga E, Schougaard Christiansen ML, Hovgaard D, Sarac SB, Camarero Jimenez J, Garcia I, Lafuente M, Sancho-López A, Salmonson T, Gisselbrecht C, Pignatti F.

Oncologist. 2018 May;23(5):594-602. doi: 10.1634/theoncologist.2017-0328. Epub 2018 Jan 25.

5.

Does access to clinical study reports from the European Medicines Agency reduce reporting biases? A systematic review and meta-analysis of randomized controlled trials on the effect of erythropoiesis-stimulating agents in cancer patients.

Rohner E, Grabik M, Tonia T, Jüni P, Pétavy F, Pignatti F, Bohlius J.

PLoS One. 2017 Dec 11;12(12):e0189309. doi: 10.1371/journal.pone.0189309. eCollection 2017. Review.

6.

EMA Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple Myeloma.

Tzogani K, van Hennik P, Walsh I, De Graeff P, Folin A, Sjöberg J, Salmonson T, Bergh J, Laane E, Ludwig H, Gisselbrecht C, Pignatti F.

Oncologist. 2018 May;23(5):631-636. doi: 10.1634/theoncologist.2017-0301. Epub 2017 Nov 30. Erratum in: Oncologist. 2018 Jul;23(7):870.

7.

Commentary: how will interventional oncology navigate the "valleys of death" for new medical devices?

Sharma RA, Fumi L, Audisio RA, Denys A, Wood BJ, Pignatti F.

Br J Radiol. 2018 Feb;91(1083):20170643. doi: 10.1259/bjr.20170643. Epub 2018 Jan 31.

PMID:
29172678
8.

Individual Trade-Offs Between Possible Benefits and Risks of Cancer Treatments: Results from a Stated Preference Study with Patients with Multiple Myeloma.

Postmus D, Richard S, Bere N, van Valkenhoef G, Galinsky J, Low E, Moulon I, Mavris M, Salmonsson T, Flores B, Hillege H, Pignatti F.

Oncologist. 2018 Jan;23(1):44-51. doi: 10.1634/theoncologist.2017-0257. Epub 2017 Oct 27.

9.

The European Medicines Agency Review of Carfilzomib for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy.

Tzogani K, Camarero Jiménez J, Garcia I, Sancho-López A, Martin M, Moreau A, Demolis P, Salmonson T, Bergh J, Laane E, Ludwig H, Gisselbrecht C, Pignatti F.

Oncologist. 2017 Nov;22(11):1339-1346. doi: 10.1634/theoncologist.2017-0184. Epub 2017 Sep 21.

10.

European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer.

Stanel SC, Sjöberg J, Salmonson T, Foggi P, Caleno M, Melchiorri D, Gravanis I, Tzogani K, Pignatti F.

ESMO Open. 2017 May 2;2(2):e000190. doi: 10.1136/esmoopen-2017-000190. eCollection 2017. Review.

11.

European Medicines Agency Perspective on Oncology Study Design for Marketing Authorization and Beyond.

Jonsson B, Martinalbo J, Pignatti F.

Clin Pharmacol Ther. 2017 May;101(5):577-579. doi: 10.1002/cpt.612. Epub 2017 Apr 4. Review.

PMID:
28073148
12.

"Threshold-crossing": A Useful Way to Establish the Counterfactual in Clinical Trials?

Eichler HG, Bloechl-Daum B, Bauer P, Bretz F, Brown J, Hampson LV, Honig P, Krams M, Leufkens H, Lim R, Lumpkin MM, Murphy MJ, Pignatti F, Posch M, Schneeweiss S, Trusheim M, Koenig F.

Clin Pharmacol Ther. 2016 Dec;100(6):699-712. doi: 10.1002/cpt.515. Epub 2016 Oct 19.

13.

The European Medicines Agency Review of Decitabine (Dacogen) for the Treatment of Adult Patients With Acute Myeloid Leukemia: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use.

Nieto M, Demolis P, Béhanzin E, Moreau A, Hudson I, Flores B, Stemplewski H, Salmonson T, Gisselbrecht C, Bowen D, Pignatti F.

Oncologist. 2016 Jun;21(6):692-700. doi: 10.1634/theoncologist.2015-0298. Epub 2016 Apr 18.

14.

Reply to the letter to the editor 'Number-Needed-To-Treat for pricing costly anti-cancer drugs. The example of Regorafenib in metastatic colorectal cancer' by Graziano et al.

Pignatti F, Martinalbo J, Jonsson B, Foggi P.

Ann Oncol. 2016 May;27(5):958. doi: 10.1093/annonc/mdw049. Epub 2016 Feb 9. No abstract available.

PMID:
26861599
15.

Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators.

Postmus D, Mavris M, Hillege HL, Salmonson T, Ryll B, Plate A, Moulon I, Eichler HG, Bere N, Pignatti F.

Clin Pharmacol Ther. 2016 May;99(5):548-54. doi: 10.1002/cpt.332. Epub 2016 Feb 17.

PMID:
26715217
16.

The European Medicines Agency Review of Brentuximab Vedotin (Adcetris) for the Treatment of Adult Patients With Relapsed or Refractory CD30+ Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use.

Gravanis I, Tzogani K, van Hennik P, de Graeff P, Schmitt P, Mueller-Berghaus J, Salmonson T, Gisselbrecht C, Laane E, Bergmann L, Pignatti F.

Oncologist. 2016 Jan;21(1):102-9. doi: 10.1634/theoncologist.2015-0276. Epub 2015 Nov 30.

17.

Early market access of cancer drugs in the EU.

Martinalbo J, Bowen D, Camarero J, Chapelin M, Démolis P, Foggi P, Jonsson B, Llinares J, Moreau A, O'Connor D, Oliveira J, Vamvakas S, Pignatti F.

Ann Oncol. 2016 Jan;27(1):96-105. doi: 10.1093/annonc/mdv506. Epub 2015 Oct 20. Review.

PMID:
26487583
18.

Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions.

Pignatti F, Ashby D, Brass EP, Eichler HG, Frey P, Hillege HL, Hori A, Levitan B, Liberti L, Löfstedt RE, McAuslane N, Micaleff A, Noel RA, Postmus D, Renn O, Sabourin BJ, Salmonson T, Walker S.

Clin Pharmacol Ther. 2015 Nov;98(5):522-33. doi: 10.1002/cpt.203. Epub 2015 Sep 11. Review.

19.

The changing world of cancer drug development: the regulatory bodies' perspective.

Gravanis I, Vleminckx C, Jonsson B, Pignatti F.

Chin Clin Oncol. 2014 Jun;3(2):22. doi: 10.3978/j.issn.2304-3865.2014.05.08.

20.

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.

Oncologist. 2015 Mar;20(3):329-34. doi: 10.1634/theoncologist.2014-0073. Epub 2015 Feb 11. Review.

21.

From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.

Eichler HG, Baird LG, Barker R, Bloechl-Daum B, Børlum-Kristensen F, Brown J, Chua R, Del Signore S, Dugan U, Ferguson J, Garner S, Goettsch W, Haigh J, Honig P, Hoos A, Huckle P, Kondo T, Le Cam Y, Leufkens H, Lim R, Longson C, Lumpkin M, Maraganore J, O'Rourke B, Oye K, Pezalla E, Pignatti F, Raine J, Rasi G, Salmonson T, Samaha D, Schneeweiss S, Siviero PD, Skinner M, Teagarden JR, Tominaga T, Trusheim MR, Tunis S, Unger TF, Vamvakas S, Hirsch G.

Clin Pharmacol Ther. 2015 Mar;97(3):234-46. doi: 10.1002/cpt.59. Epub 2015 Feb 4.

PMID:
25669457
22.

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.

Tzogani K, Skibeli V, Westgaard I, Dalhus M, Thoresen H, Slot KB, Damkier P, Hofland K, Borregaard J, Ersbøll J, Salmonson T, Pieters R, Sylvester R, Mickisch G, Bergh J, Pignatti F.

Oncologist. 2015 Feb;20(2):196-201. doi: 10.1634/theoncologist.2014-0177. Epub 2015 Jan 23. Review.

23.

Assessment of benefits and risks in development of targeted therapies for cancer--The view of regulatory authorities.

Pignatti F, Jonsson B, Blumenthal G, Justice R.

Mol Oncol. 2015 May;9(5):1034-41. doi: 10.1016/j.molonc.2014.10.003. Epub 2014 Oct 16. Review.

24.
25.

Efficacy and safety of rituximab with and without methotrexate in the treatment of rheumatoid arthritis patients: results from the GISEA register.

Sebastiani M, Anelli MG, Atzeni F, Bazzani C, Farina I, Fedele AL, Favalli EG, Fineschi I, Cino N, Dal Forno I, Gasparini S, Cassarà E, Giardina R, Bruschi E, Addimanda O, Cassone G, Lopriore S, Sarzi-Puttini P, Filippini M, Pignatti F, Gremese E, Biggioggero M, Manganelli S, Amato G, Caimmi C, Salaffi F, Iannone F, Ferri C, Sandri G, Lapadula G, Gorla R, Govoni M, Ferraccioli G, Marchesoni A, Galeazzi M, Foti R, Carletto A, Cantini F, Triolo G, Epis OM, Salvarani C; Italian Study Group on Early Arthritides (GISEA).

Joint Bone Spine. 2014 Dec;81(6):508-12. doi: 10.1016/j.jbspin.2014.06.011. Epub 2014 Jul 28.

PMID:
25082646
26.

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.

Boix-Perales H, Borregaard J, Jensen KB, Ersbøll J, Galluzzo S, Giuliani R, Ciceroni C, Melchiorri D, Salmonson T, Bergh J, Schellens JH, Pignatti F.

Oncologist. 2014 Jul;19(7):766-73. doi: 10.1634/theoncologist.2013-0348. Epub 2014 Jun 13. Review.

27.

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.

Hanaizi Z, Unkrig C, Enzmann H, Camarero J, Sancho-Lopez A, Salmonson T, Gisselbrecht C, Laane E, Pignatti F.

Oncologist. 2014 Apr;19(4):421-5. doi: 10.1634/theoncologist.2013-0294. Epub 2014 Mar 25.

28.

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

Pignatti F, Ehmann F, Hemmings R, Jonsson B, Nuebling M, Papaluca-Amati M, Posch M, Rasi G.

Clin Cancer Res. 2014 Mar 15;20(6):1458-68. doi: 10.1158/1078-0432.CCR-13-1571.

29.

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

Eichler HG, Pétavy F, Pignatti F, Rasi G.

N Engl J Med. 2013 Oct 24;369(17):1577-9. doi: 10.1056/NEJMp1310771. Epub 2013 Oct 21. No abstract available.

30.

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.

Oncologist. 2013;18(9):1032-42. doi: 10.1634/theoncologist.2013-0092. Epub 2013 Aug 21.

31.

The European Medicines Agency review of pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphomas: summary of the scientific assessment of the committee for medicinal products for human use.

Péan E, Flores B, Hudson I, Sjöberg J, Dunder K, Salmonson T, Gisselbrecht C, Laane E, Pignatti F.

Oncologist. 2013;18(5):625-33. doi: 10.1634/theoncologist.2013-0020. Epub 2013 Apr 24.

32.

A randomised phase III intergroup trial comparing high-dose infusional 5-fluorouracil with or without folinic acid with standard bolus 5-fluorouracil/folinic acid in the adjuvant treatment of stage III colon cancer: the Pan-European Trial in Adjuvant Colon Cancer 2 study.

Köhne CH, Bedenne L, Carrato A, Bouché O, Popov I, Gaspà L, Valladares M, Rougier P, Gog C, Reichardt P, Wils J, Pignatti F, Biertz F.

Eur J Cancer. 2013 May;49(8):1868-75. doi: 10.1016/j.ejca.2013.01.030. Epub 2013 Apr 6.

PMID:
23571150
33.

The European Medicines Agency approval of 5-aminolaevulinic acid (Ameluz) for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

Tzogani K, Straube M, Hoppe U, Kiely P, O'Dea G, Enzmann H, Salmon P, Salmonson T, Pignatti F.

J Dermatolog Treat. 2014 Oct;25(5):371-4. doi: 10.3109/09546634.2013.789474. Epub 2013 May 21.

PMID:
23550714
34.

The European Medicines Agency review of vemurafenib (Zelboraf®) for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

da Rocha Dias S, Salmonson T, van Zwieten-Boot B, Jonsson B, Marchetti S, Schellens JH, Giuliani R, Pignatti F.

Eur J Cancer. 2013 May;49(7):1654-61. doi: 10.1016/j.ejca.2013.01.015. Epub 2013 Mar 5.

PMID:
23481513
35.

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

Pignatti F, Flores B, Jonsson B.

Am J Hematol. 2012 Oct;87(10):943-4. doi: 10.1002/ajh.23300. Epub 2012 Sep 17. No abstract available.

36.

The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use.

Pean E, Klaar S, Berglund EG, Salmonson T, Borregaard J, Hofland KF, Ersbøll J, Abadie E, Giuliani R, Pignatti F.

Clin Cancer Res. 2012 Sep 1;18(17):4491-7. doi: 10.1158/1078-0432.CCR-11-3075. Epub 2012 Jul 24.

37.

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.

Oncologist. 2012;17(4):543-9. doi: 10.1634/theoncologist.2011-0364. Epub 2012 Apr 3. Review.

38.

The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

Hanaizi Z, van Zwieten-Boot B, Calvo G, Lopez AS, van Dartel M, Camarero J, Abadie E, Pignatti F.

Eur J Cancer. 2012 Jan;48(2):237-42. doi: 10.1016/j.ejca.2011.09.018. Epub 2011 Oct 24. Review.

PMID:
22030452
39.

The European Medicines Agency review of pazopanib for the treatment of advanced renal cell carcinoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

Nieto M, Borregaard J, Ersbøll J, ten Bosch GJ, van Zwieten-Boot B, Abadie E, Schellens JH, Pignatti F.

Clin Cancer Res. 2011 Nov 1;17(21):6608-14. doi: 10.1158/1078-0432.CCR-11-1734. Epub 2011 Oct 5. Review.

40.

The European Medicines Agency review of Tegafur/Gimeracil/Oteracil (Teysuno™) for the treatment of advanced gastric cancer when given in combination with cisplatin: summary of the Scientific Assessment of the Committee for medicinal products for human use (CHMP).

Matt P, van Zwieten-Boot B, Calvo Rojas G, Ter Hofstede H, Garcia-Carbonero R, Camarero J, Abadie E, Pignatti F.

Oncologist. 2011;16(10):1451-7. doi: 10.1634/theoncologist.2011-0224. Epub 2011 Sep 30. Review.

41.

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

Pignatti F, Luria X, Abadie E, Eichler HG.

Lancet Oncol. 2011 Sep;12(10):930-1. doi: 10.1016/S1470-2045(11)70229-7. No abstract available.

PMID:
21958501
42.

The European Medicines Agency: an overview of its mission, responsibilities, and recent initiatives in cancer drug regulation.

Pignatti F, Gravanis I, Herold R, Vamvakas S, Jonsson B, Marty M.

Clin Cancer Res. 2011 Aug 15;17(16):5220-5. doi: 10.1158/1078-0432.CCR-11-0623.

43.

The European Medicines Agency review of eltrombopag (Revolade) for the treatment of adult chronic immune (idiopathic) thrombocytopenic purpura: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

Nieto M, Calvo G, Hudson I, Feldschreiber P, Brown D, Lee CC, Lay G, Valeri A, Abadie E, Thomas A, Pignatti F.

Haematologica. 2011 Sep;96(9):e33-40. doi: 10.3324/haematol.2011.048819. Epub 2011 Jun 28. Review.

44.

Is it time to abandon complete blinded independent central radiological evaluation of progression in registration trials?

Pignatti F, Hemmings R, Jonsson B.

Eur J Cancer. 2011 Aug;47(12):1759-62. doi: 10.1016/j.ejca.2011.05.009. No abstract available.

PMID:
21641204
46.

Ultrafiltration for the treatment of diuretic-resistant, recurrent, acute decompensated heart failure: experience in a single center.

De Maria E, Pignatti F, Patrizi G, Benenati PM, Ricci S, Cappelli S.

J Cardiovasc Med (Hagerstown). 2010 Aug;11(8):599-604. doi: 10.2459/JCM.0b013e3283383275.

PMID:
20442667
47.

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

Eichler HG, Pignatti F, Flamion B, Leufkens H, Breckenridge A.

Nat Rev Drug Discov. 2008 Oct;7(10):818-26. doi: 10.1038/nrd2664. Epub 2008 Sep 12. Review.

PMID:
18787530
48.

Overview of the European regulatory approval system.

Pignatti F, Boone H, Moulon I.

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

PMID:
15069985
49.

EMEA and Gene Therapy Medicinal Products Development in the European Union.

Papaluca Amati M, Pignatti F, Nolte A, Amerasinghe N, Gustafsson D, Moulon I, Le Courtois P.

J Biomed Biotechnol. 2003;2003(1):3-8.

50.

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

Pignatti F, Aronsson B, Gate N, Vamvakas S, Wade G, Moulon I, Le Courtois P.

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

PMID:
12525957

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