Stelios Tsigkos
Overview
Explore the profile of Stelios Tsigkos including associated specialties, affiliations and a list of published articles.
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Articles
19
Citations
425
Followers
0
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Recent Articles
1.
Sheean M, Naumann-Winter F, Capovilla G, Kalland M, Malikova E, Mariz S, et al.
Front Med (Lausanne)
. 2021 Sep;
8:744625.
PMID: 34513895
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...
2.
Tsigkos S, Mariz S, Sheean M, Larsson K, Magrelli A, Stoyanova-Beninska V
Front Med (Lausanne)
. 2021 Jul;
8:698534.
PMID: 34249982
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...
3.
Sheean M, Malikova E, Duarte D, Capovilla G, Fregonese L, Hofer M, et al.
Drug Discov Today
. 2019 Nov;
25(2):274-291.
PMID: 31704277
This review provides an overview of nonclinical in vivo models that can be used to support orphan designation in selected rare infectious diseases in Europe, with the aim to inform...
4.
OConnor D, Sheean M, Hofer M, Tsigkos S, Mariz S, Fregonese L, et al.
Nat Rev Drug Discov
. 2019 Apr;
18(7):479-480.
PMID: 30940922
No abstract available.
5.
Fregonese L, Greene L, Hofer M, Magrelli A, Naumann-Winter F, Larsson K, et al.
Drug Discov Today
. 2017 Oct;
23(1):90-100.
PMID: 29024805
In the European Union demonstration of 'significant benefit' is mandatory if satisfactory methods exist for a disease targeted by a new orphan medicinal product. Significant benefit is required at the...
6.
Sheean M, Stoyanova-Beninska V, Capovilla G, Duarte D, Hofer M, Hoffmann M, et al.
Drug Discov Today
. 2017 Oct;
23(1):26-48.
PMID: 28987289
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...
7.
Tsigkos S, Hofer M, Sheean M, Mariz S, Larsson K, Naumann-Winter F, et al.
Drug Discov Today
. 2017 Jun;
23(3):681-686.
PMID: 28647377
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...
8.
Polsinelli B, Tsigkos S, Naumann-Winter F, Mariz S, Sepodes B
Orphanet J Rare Dis
. 2017 Jan;
12(1):17.
PMID: 28109318
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....
9.
Tsigkos S, Mariz S, Llinares J, Fregonese L, Aarum S, Naumann-Winter F, et al.
Orphanet J Rare Dis
. 2015 Oct;
10:129.
PMID: 26444545
No abstract available.
10.
Tsigkos S, Mariz S, Llinares J, Fregonese L, Aarum S, Naumann-Winter F, et al.
Orphanet J Rare Dis
. 2014 Dec;
9:175.
PMID: 25475155
In the European Union, sponsors have the responsibility to demonstrate the "intention to diagnose, prevent or treat" a serious and rare condition before the Committee of Orphan Medicinal Products (COMP),...