Zobrazeno 1 - 10
of 20
pro vyhledávání: '"Stelios, Tsigkos"'
Autor:
Maria E. Sheean, Frauke Naumann-Winter, Giuseppe Capovilla, Maria Elisabeth Kalland, Eva Malikova, Segundo Mariz, Darius Matusevicius, Robert Nistico, Brigitte Schwarzer-Daum, Stelios Tsigkos, Kyriaki Tzogani, Kristina Larsson, Armando Magrelli, Violeta Stoyanova-Beninska
Publikováno v:
Frontiers in Medicine, Vol 8 (2021)
Since the implementation of the EU Orphan Regulation in 2000, the Committee for Orphan Medicinal Products at the European Medicines Agency has been evaluating the benefits of proposed orphan medicines vs. satisfactory treatment methods. This type of
Externí odkaz:
https://doaj.org/article/b2d1091cdc5d4925bfece7d576c08a3c
Autor:
Stelios Tsigkos, Segundo Mariz, Maria Elzbieta Sheean, Kristina Larsson, Armando Magrelli, Violeta Stoyanova-Beninska
Publikováno v:
Frontiers in Medicine, Vol 8 (2021)
Twenty years of orphan regulation in Europe have now elapsed, with almost 2,400 orphan designated medicinal products and more than 190 orphan products authorised in the EU. Alongside the evolution in understanding of rare diseases, considerable regul
Externí odkaz:
https://doaj.org/article/a99ae06f9599491a8f6393476c5b9291
Autor:
Segundo Mariz, Fernando Mendez-Hermida, Violeta Stoyanova-Beninska, Maria E. Sheean, Laura Fregonese, Dinko Vitezić, Armando Magrelli, Nikolaos V. Sipsas, Tim Leest, Stelios Tsigkos, Dinah Duarte, Bruno Sepodes, Eva Malikova, Robert Nistico, Giuseppe Capovilla, Matthias P. Hofer, Kristina Larsson
Publikováno v:
Drug Discovery Today
Volume 25
Issue 2
Volume 25
Issue 2
The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) is responsible for evaluating applications for orphan designation (OMPDs) and for deciding the orphan status at the time of marketing authorization of medicines
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e58e9b1e4b49f0c050ffbef7f5ce2103
http://hdl.handle.net/2108/227456
http://hdl.handle.net/2108/227456
Autor:
Michel Hoffmann, Matthias P. Hofer, Kristina Larsson, Violeta Stoyanova-Beninska, Milton Bonelli, Evyenia Shaili, Maria E. Sheean, Mario Ricciardi, Giuseppe Capovilla, Bruno Sepodes, Dinah Duarte, Armando Magrelli, Stelios Tsigkos, Benedetta Polsinelli, Pavel Balabanov, Segundo Mariz
Publikováno v:
Drug discovery today. 23(1)
Here, we provide an in-depth literature and experience-based review of nonclinical models and data used to support orphan medicinal product designations (OMPDs) in rare neurodegenerative conditions. The Committee for Orphan Medicinal Products (COMP)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::51a1b89674041488458c13bc8b928ced
https://pubmed.ncbi.nlm.nih.gov/28987289
https://pubmed.ncbi.nlm.nih.gov/28987289
Publikováno v:
Orphanet Journal of Rare Diseases
The Committee for Orphan Medicinal Products (COMP) evaluates prevalence of rare conditions as one of the criteria for granting an orphan designation with a prevalence threshold of 5 in 10.000. At the time of Marketing Authorisation (MA) these criteri
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::196d7ebc912c1665f4740522ce648e43
https://doi.org/10.1186/s13023-017-0567-7
https://doi.org/10.1186/s13023-017-0567-7
Autor:
Bruno Sepodes, Laura Fregonese, Maria Elzbieta Sheean, Segundo Mariz, Kristina Larsson, Frauke Naumann-Winter, Stelios Tsigkos, Matthias P. Hofer
Publikováno v:
Drug discovery today. 23(3)
In the European Union (EU) legislative framework for orphan medicinal product designation, establishing that a condition affects not more than five in 10,000 people is a prerequisite for applications based on rarity. Demonstrating this requirement to
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c758ca33fba8747b90fc0b53a7c8bf09
https://pubmed.ncbi.nlm.nih.gov/28647377
https://pubmed.ncbi.nlm.nih.gov/28647377
Autor:
Eleonora Dehlink, Laura Fregonese, Bruno Sepodes, Stiina Aarum, Jordi Llinares, Stelios Tsigkos, Segundo Mariz
Publikováno v:
Expert Opinion on Orphan Drugs. 2:1181-1186
This is a review of the post-designation incentives framework that exists in Europe under its Orphan Medicinal Designation System. The aim of the article is to review and highlight specific regulatory mechanisms which are used or tailored to help in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f18f21f83c4a28630ded7191381bccf8
https://doi.org/10.1517/21678707.2014.973849
https://doi.org/10.1517/21678707.2014.973849
Autor:
Daniel O’Connor, Ingeborg Barišić, Bruno Sepodes, Maria E. Sheean, Frauke Naumann-Winter, Laura Fregonese, Kerstin Westermark, Matthias P. Hofer, Violeta Stoyanova-Beninska, Virginie Hivert, Segundo Mariz, Giuseppe Capovilla, Kristina Larsson, Armando Magrelli, Stelios Tsigkos
Publikováno v:
Nature Reviews Drug Discovery. 18:479-480
The European orphan regulation incentivizes the development of medicines for conditions for which the pharmaceutical industry would be unwilling to develop medicines under normal market conditions. Defining an orphan condition is the starting point o
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3fa1a5c55a5b1f916a1fede97eeeb96e
https://doi.org/10.1038/nrd.2018.128
https://doi.org/10.1038/nrd.2018.128
Autor:
Charis Roussos, Theodoros P. Vassilakopoulos, Zongmin Zhou, Andreas Papapetropoulos, Stelios Tsigkos, Herbert Waldmann, Eleni Gourzoulidou, Athanassios Giannis, Thomas Cottin, Anastasia Pyriochou
Publikováno v:
British Journal of Pharmacology. 152:1207-1214
Background and purpose: Angiopoietins (Ang) are crucial for new blood vessel formation and exert their effects by acting on the Tie2 receptor. We have recently described a sulindac analogue 2-((1E,Z)-1-benzylidene-5-bromo-2-methyl-1H-inden-3-yl)aceti
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::13e1bf92ceb00a1afcc7aec9c2a1615d
https://doi.org/10.1038/sj.bjp.0707534
https://doi.org/10.1038/sj.bjp.0707534
Autor:
Anastasia Kotanidou, Apostolos Armaganidis, Christina Sotiropoulou, Charis Roussos, Chariclea Athanasiou, Spyros Zakynthinos, Stelios Tsigkos, Stylianos E. Orfanos, Constantinos Glynos, Ioanna Dimopoulou, Andreas Papapetropoulos
Publikováno v:
Critical Care Medicine. 35:199-206
Angiopoietin (Ang)-2 is an endothelium-specific growth factor, regulated by proinflammatory stimuli, that destabilizes vascular endothelium and increases vascular leakage; consequently, Ang-2 may contribute to sepsis pathophysiology. We have studied
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::47701f2f7cddaac26ff1240d7bfd8215
https://doi.org/10.1097/01.ccm.0000251640.77679.d7
https://doi.org/10.1097/01.ccm.0000251640.77679.d7