BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

385 related articles for article (PubMed ID: 36034814)

  • 1. Licensing of Orphan Medicinal Products-Use of Real-World Data and Other External Data on Efficacy Aspects in Marketing Authorization Applications Concluded at the European Medicines Agency Between 2019 and 2021.
    Naumann-Winter F; Wolter F; Hermes U; Malikova E; Lilienthal N; Meier T; Kalland ME; Magrelli A
    Front Pharmacol; 2022; 13():920336. PubMed ID: 36034814
    [No Abstract]   [Full Text] [Related]  

  • 2. Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen.
    Giannuzzi V; Conte R; Landi A; Ottomano SA; Bonifazi D; Baiardi P; Bonifazi F; Ceci A
    Orphanet J Rare Dis; 2017 Apr; 12(1):64. PubMed ID: 28372595
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Advancing rare disease treatment: EMA's decade-long insights into engineered adoptive cell therapy for rare cancers and orphan designation.
    Kalland ME; Pose-Boirazian T; Palomo GM; Naumann-Winter F; Costa E; Matusevicius D; Duarte DM; Malikova E; Vitezic D; Larsson K; Magrelli A; Stoyanova-Beninska V; Mariz S
    Gene Ther; 2024 Mar; ():. PubMed ID: 38480914
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Regulatory Aspects for Approval of Advanced Therapy Medicinal Products in the EU.
    Fürst-Ladani S; Bührer A; Fürst W; Schober-Ladani N
    Handb Exp Pharmacol; 2024; 284():367-387. PubMed ID: 37017789
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.
    Giannuzzi V; Landi A; Bosone E; Giannuzzi F; Nicotri S; Torrent-Farnell J; Bonifazi F; Felisi M; Bonifazi D; Ceci A
    BMJ Open; 2017 Sep; 7(9):e017358. PubMed ID: 28893754
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Single-arm trials supporting the approval of anticancer medicinal products in the European Union: contextualization of trial results and observed clinical benefit.
    Mulder J; Teerenstra S; van Hennik PB; Pasmooij AMG; Stoyanova-Beninska V; Voest EE; de Boer A
    ESMO Open; 2023 Apr; 8(2):101209. PubMed ID: 37054504
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.
    Iglesias-Lopez C; Obach M; Vallano A; Agustí A
    Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Are products with an orphan designation for oncology indications different from products for other rare indications? A retrospective analysis of European orphan designations granted between 2002-2012.
    Pauwels K; Huys I; Casteels M; Larsson K; Voltz C; Penttila K; Morel T; Simoens S
    Orphanet J Rare Dis; 2017 Feb; 12(1):36. PubMed ID: 28209180
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Orphan drugs, orphan diseases. The first decade of orphan drug legislation in the EU.
    Joppi R; Bertele' V; Garattini S
    Eur J Clin Pharmacol; 2013 Apr; 69(4):1009-24. PubMed ID: 23090701
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.
    Ghadanian M; Schafheutle E
    Ther Innov Regul Sci; 2024 Jan; 58(1):79-113. PubMed ID: 37861859
    [TBL] [Abstract][Full Text] [Related]  

  • 11. INGN 201: Ad-p53, Ad5CMV-p53, adenoviral p53, p53 gene therapy--introgen, RPR/INGN 201.
    Drugs R D; 2007; 8(3):176-87. PubMed ID: 17472413
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Traits, trends and hits of orphan drug designations in cystic fibrosis.
    Costa E; Girotti S; van den Ham HA; Cipolli M; van der Ent CK; Taylor-Cousar JL; Leufkens HGM
    J Cyst Fibros; 2023 Sep; 22(5):949-957. PubMed ID: 37507282
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Trends in orphan medicinal products approvals in the European Union between 2010-2022.
    Bouwman L; Sepodes B; Leufkens H; Torre C
    Orphanet J Rare Dis; 2024 Feb; 19(1):91. PubMed ID: 38413985
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Availability, accessibility and delivery to patients of the 28 orphan medicines approved by the European Medicine Agency for hereditary metabolic diseases in the MetabERN network.
    Heard JM; Vrinten C; Schlander M; Bellettato CM; van Lingen C; Scarpa M;
    Orphanet J Rare Dis; 2020 Jan; 15(1):3. PubMed ID: 31907071
    [TBL] [Abstract][Full Text] [Related]  

  • 15. From promising molecules to orphan drugs: Early clinical drug development.
    Dooms M
    Intractable Rare Dis Res; 2017 Feb; 6(1):29-34. PubMed ID: 28357178
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Access to medicines for rare diseases: A European regulatory roadmap for academia.
    Rosenberg N; van den Berg S; Stolwijk NN; Jacobs BAW; Post HC; Pasmooij AMG; de Visser SJ; Hollak CEM
    Front Pharmacol; 2023; 14():1142351. PubMed ID: 36925633
    [No Abstract]   [Full Text] [Related]  

  • 17. Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe.
    Jonker CJ; Bakker E; Kurz X; Plueschke K
    Front Pharmacol; 2022; 13():924648. PubMed ID: 35991868
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Review and comparison of clinical evidence submitted to support European Medicines Agency market authorization of orphan-designated oncological treatments.
    Winstone J; Chadda S; Ralston S; Sajosi P
    Orphanet J Rare Dis; 2015 Oct; 10():139. PubMed ID: 26511061
    [TBL] [Abstract][Full Text] [Related]  

  • 19. [European incentives for orphan medicinal products].
    Enzmann H; Lütz J
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2008 May; 51(5):500-8. PubMed ID: 18696141
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Cancer drugs for solid tumors approved by the EMA since 2014: an overview of pivotal clinical trials.
    Lasala R; Logreco A; Romagnoli A; Santoleri F; Musicco F; Costantini A
    Eur J Clin Pharmacol; 2020 Jun; 76(6):843-850. PubMed ID: 32125472
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 20.