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  1. Article ; Online: Unveiling the impacts of FDA Breakthrough Therapy Designation: a dual-perspective examination of economic and developmental outcomes for biotechnology companies.

    Williamson, Joab / Spicer, Alexander James / Louramo, Elina / Jalkanen, Juho

    Drug discovery today

    2024  Volume 29, Issue 4, Page(s) 103919

    Abstract: Biotechnology and small pharma companies must recognize the opportunity presented by FDA Breakthrough Therapy Designation (BTD) to expedite drug development for serious conditions. This paper evaluates BTD economic and developmental impacts on such ... ...

    Abstract Biotechnology and small pharma companies must recognize the opportunity presented by FDA Breakthrough Therapy Designation (BTD) to expedite drug development for serious conditions. This paper evaluates BTD economic and developmental impacts on such companies. Analysis of 29 BTD events from 2017 to 2022 revealed immediate share price boosts and improved drug approval rates, alongside faster development times. Yet, long-term share prices underperformed relative to the broader market, underscoring the persistent risks in pharma investments. Although offering new insights, the limited sample size calls for further investigation.
    MeSH term(s) United States ; Biotechnology ; Investments ; Drug Approval ; United States Food and Drug Administration
    Language English
    Publishing date 2024-02-15
    Publishing country England
    Document type Journal Article
    ZDB-ID 1324988-5
    ISSN 1878-5832 ; 1359-6446
    ISSN (online) 1878-5832
    ISSN 1359-6446
    DOI 10.1016/j.drudis.2024.103919
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 4725: Show issues Location:
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  2. Article ; Online: Small pharma vendor management practices in clinical trials: A case study within Faron Pharmaceuticals.

    Williamson, Joab / Jalkanen, Juho / Lahtinen, Maria

    Drug discovery today

    2023  Volume 28, Issue 6, Page(s) 103553

    Abstract: Many small pharmaceutical companies find that they lack the resources, knowledge and expertise of the regulatory landscape for adequate vendor management in clinical trials, making the organization vulnerable. Recent research suggests that some ... ...

    Abstract Many small pharmaceutical companies find that they lack the resources, knowledge and expertise of the regulatory landscape for adequate vendor management in clinical trials, making the organization vulnerable. Recent research suggests that some pharmaceutical companies have found themselves out of compliance with ICH, FDA or EMA guidelines. This paper aims to perform a comprehensive review of the regulatory landscape for vendor selection, oversight and ongoing evaluation in clinical trials. In addition, the case study performed studies the practices recently implemented at small pharmaceutical company Faron Pharmaceuticals to assess regulatory compliance and identify any potential best practices. Faron Pharmaceuticals conducted a process improvement activity at the beginning of 2022 to improve the vendor selection, oversight and evaluation of their clinical trial partners. The results of this case study indicate that Faron Pharmaceuticals' processes are regulatory compliant, suggesting that QTLs, KPIs, SOPs and communication plans are effective vendor oversight mechanisms for small pharmaceutical companies to utilize.
    MeSH term(s) Drug Industry ; Communication ; Small Business ; Pharmaceutical Preparations
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2023-03-13
    Publishing country England
    Document type Review ; Journal Article
    ZDB-ID 1324988-5
    ISSN 1878-5832 ; 1359-6446
    ISSN (online) 1878-5832
    ISSN 1359-6446
    DOI 10.1016/j.drudis.2023.103553
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 4725: Show issues Location:
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  3. Article ; Online: Letter to the Editor:

    Spicer, Alexander J / Jalkanen, Juho / Louramo, Elina / Hakovirta, Harri / Venermo, Maarit / Jalkanen, Sirpa

    Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research

    2022  Volume 42, Issue 11, Page(s) 590–591

    MeSH term(s) Interferon Type I ; Autoantibodies
    Chemical Substances Interferon Type I ; Autoantibodies
    Language English
    Publishing date 2022-09-30
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 1226675-9
    ISSN 1557-7465 ; 1079-9907
    ISSN (online) 1557-7465
    ISSN 1079-9907
    DOI 10.1089/jir.2022.0156
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1748: Show issues Location:
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  4. Article ; Online: Interferon beta-1a for COVID-19: critical importance of the administration route.

    Jalkanen, Juho / Hollmén, Maija / Jalkanen, Sirpa

    Critical care (London, England)

    2020  Volume 24, Issue 1, Page(s) 335

    MeSH term(s) Antiviral Agents/administration & dosage ; Betacoronavirus ; COVID-19 ; Coronavirus Infections/drug therapy ; Dose-Response Relationship, Drug ; Humans ; Injections, Intramuscular ; Injections, Intravenous ; Interferon beta-1a/administration & dosage ; Pandemics ; Pneumonia, Viral/drug therapy ; SARS-CoV-2
    Chemical Substances Antiviral Agents ; Interferon beta-1a (XRO4566Q4R)
    Keywords covid19
    Language English
    Publishing date 2020-06-12
    Publishing country England
    Document type Letter
    ZDB-ID 2041406-7
    ISSN 1466-609X ; 1364-8535
    ISSN (online) 1466-609X
    ISSN 1364-8535
    DOI 10.1186/s13054-020-03048-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 5517: Show issues Location:
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  5. Article ; Online: Interferon beta-1a for COVID-19

    Juho Jalkanen / Maija Hollmén / Sirpa Jalkanen

    Critical Care, Vol 24, Iss 1, Pp 1-

    critical importance of the administration route

    2020  Volume 3

    Keywords Medical emergencies. Critical care. Intensive care. First aid ; RC86-88.9 ; covid19
    Language English
    Publishing date 2020-06-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Glucocorticoids inhibit type I IFN beta signaling and the upregulation of CD73 in human lung.

    Jalkanen, Juho / Pettilä, Ville / Huttunen, Teppo / Hollmén, Maija / Jalkanen, Sirpa

    Intensive care medicine

    2020  Volume 46, Issue 10, Page(s) 1937–1940

    MeSH term(s) Glucocorticoids ; Humans ; Lung ; Signal Transduction ; Up-Regulation
    Chemical Substances Glucocorticoids
    Keywords covid19
    Language English
    Publishing date 2020-05-19
    Publishing country United States
    Document type Letter
    ZDB-ID 80387-x
    ISSN 1432-1238 ; 0340-0964 ; 0342-4642 ; 0935-1701
    ISSN (online) 1432-1238
    ISSN 0340-0964 ; 0342-4642 ; 0935-1701
    DOI 10.1007/s00134-020-06086-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1089: Show issues Location:
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  7. Article ; Online: Polymorphism in interferon alpha/beta receptor contributes to glucocorticoid response and outcome of ARDS and COVID-19.

    Jalkanen, Juho / Khan, Sofia / Elima, Kati / Huttunen, Teppo / Wang, Ning / Hollmén, Maija / Elo, Laura L / Jalkanen, Sirpa

    Critical care (London, England)

    2023  Volume 27, Issue 1, Page(s) 112

    Abstract: Background: The use of glucocorticoids has given contradictory results for treating acute respiratory distress syndrome (ARDS). The use of intravenous Interferon beta (IFN β) for the treatment of ARDS was recently tested in a phase III ARDS trial ( ... ...

    Abstract Background: The use of glucocorticoids has given contradictory results for treating acute respiratory distress syndrome (ARDS). The use of intravenous Interferon beta (IFN β) for the treatment of ARDS was recently tested in a phase III ARDS trial (INTEREST), in which more than half of the patients simultaneously received glucocorticoids. Trial results showed deleterious effects of glucocorticoids when administered together with IFN β, and therefore, we aimed at finding the reason behind this.
    Methods: We first sequenced the genes encoding the IFN α/β receptor of the patients, who participated in the INTEREST study (ClinicalTrials.gov Identifier:  NCT02622724 , November 24, 2015) in which the patients were randomized to receive an intravenous injection of IFN β-1a (144 patients) or placebo (152 patients). Genetic background was analyzed against clinical outcome, concomitant medication, and pro-inflammatory cytokine levels. Thereafter, we tested the influence of the genetic background on IFN α/β receptor expression in lung organ cultures and whether, it has any effect on transcription factors STAT1 and STAT2 involved in IFN signaling.
    Results: We found a novel disease association of a SNP rs9984273, which is situated in the interferon α/β receptor subunit 2 (IFNAR2) gene in an area corresponding to a binding motif of the glucocorticoid receptor (GR). The minor allele of SNP rs9984273 associates with higher IFNAR expression, more rapid decrease of IFN γ and interleukin-6 (IL-6) levels and better outcome in IFN β treated patients with ARDS, while the major allele associates with a poor outcome especially under concomitant IFN β and glucocorticoid treatment. Moreover, the minor allele of rs9984273 associates with a less severe form of coronavirus diseases (COVID-19) according to the COVID-19 Host Genetics Initiative database.
    Conclusions: The distribution of this SNP within clinical study arms may explain the contradictory results of multiple ARDS studies and outcomes in COVID-19 concerning type I IFN signaling and glucocorticoids.
    MeSH term(s) Humans ; Glucocorticoids/pharmacology ; Glucocorticoids/therapeutic use ; COVID-19/genetics ; Interferon-beta/pharmacology ; Interferon-beta/therapeutic use ; Respiratory Distress Syndrome/drug therapy ; Respiratory Distress Syndrome/genetics ; Interferon-alpha
    Chemical Substances Glucocorticoids ; Interferon-beta (77238-31-4) ; Interferon-alpha
    Language English
    Publishing date 2023-03-16
    Publishing country England
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 2041406-7
    ISSN 1466-609X ; 1364-8535
    ISSN (online) 1466-609X
    ISSN 1364-8535
    DOI 10.1186/s13054-023-04388-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 5517: Show issues Location:
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  9. Article ; Online: Interferon beta-1a for COVID-19

    Jalkanen, Juho / Hollmén, Maija / Jalkanen, Sirpa

    Critical Care

    critical importance of the administration route

    2020  Volume 24, Issue 1

    Keywords Critical Care and Intensive Care Medicine ; covid19
    Language English
    Publisher Springer Science and Business Media LLC
    Publishing country us
    Document type Article ; Online
    ZDB-ID 2041406-7
    ISSN 1364-8535
    ISSN 1364-8535
    DOI 10.1186/s13054-020-03048-5
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Zs.A 5517: Show issues Location:
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  10. Article ; Online: Disadvantages of high fluid infusion rate in cardiac surgery.

    Koskinen, Atte / Aittokallio, Jenni / Gunn, Jarmo / Relander, Arto / Viikinkoski, Emma / Vasankari, Tuija / Jalkanen, Juho / Hollmén, Maija / Kiviniemi, Tuomas O

    European journal of anaesthesiology

    2022  Volume 39, Issue 12, Page(s) 963–966

    MeSH term(s) Humans ; Cardiac Surgical Procedures
    Language English
    Publishing date 2022-10-11
    Publishing country England
    Document type Journal Article
    ZDB-ID 605770-6
    ISSN 1365-2346 ; 0265-0215
    ISSN (online) 1365-2346
    ISSN 0265-0215
    DOI 10.1097/EJA.0000000000001764
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1955: Show issues Location:
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