What lurks in the shadows of the openness hyperbole for biopharmaceuticals?

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Standard

What lurks in the shadows of the openness hyperbole for biopharmaceuticals? / Rajam, Neethu; Minssen, Timo.

I: Drug Development Research, Bind 80, Nr. 3, 11.05.2019, s. 282-284.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

Rajam, N & Minssen, T 2019, 'What lurks in the shadows of the openness hyperbole for biopharmaceuticals?', Drug Development Research, bind 80, nr. 3, s. 282-284. https://doi.org/10.1002/ddr.21526

APA

Rajam, N., & Minssen, T. (2019). What lurks in the shadows of the openness hyperbole for biopharmaceuticals? Drug Development Research, 80(3), 282-284. https://doi.org/10.1002/ddr.21526

Vancouver

Rajam N, Minssen T. What lurks in the shadows of the openness hyperbole for biopharmaceuticals? Drug Development Research. 2019 maj 11;80(3):282-284. https://doi.org/10.1002/ddr.21526

Author

Rajam, Neethu ; Minssen, Timo. / What lurks in the shadows of the openness hyperbole for biopharmaceuticals?. I: Drug Development Research. 2019 ; Bind 80, Nr. 3. s. 282-284.

Bibtex

@article{85778b3c8882458fb107f7d2f6fbb012,
title = "What lurks in the shadows of the openness hyperbole for biopharmaceuticals?",
abstract = "Recent clinical trials transparency initiatives signify laudable progress. Yet, a closer look on legal developments reveals that the protection of commercially confidential information and personal data continues to pose substantial challenges for drug innovation. This article depicts these developments with a particular focus on the European Medicines Agency (EMA) and biologics. We argue that to promote the development of innovative biologics and biosimilars, the EMA must carefully consider and address such challenges.",
author = "Neethu Rajam and Timo Minssen",
year = "2019",
month = may,
day = "11",
doi = "10.1002/ddr.21526",
language = "English",
volume = "80",
pages = "282--284",
journal = "Drug Development Research",
issn = "0272-4391",
publisher = "JohnWiley & Sons, Inc.",
number = "3",

}

RIS

TY - JOUR

T1 - What lurks in the shadows of the openness hyperbole for biopharmaceuticals?

AU - Rajam, Neethu

AU - Minssen, Timo

PY - 2019/5/11

Y1 - 2019/5/11

N2 - Recent clinical trials transparency initiatives signify laudable progress. Yet, a closer look on legal developments reveals that the protection of commercially confidential information and personal data continues to pose substantial challenges for drug innovation. This article depicts these developments with a particular focus on the European Medicines Agency (EMA) and biologics. We argue that to promote the development of innovative biologics and biosimilars, the EMA must carefully consider and address such challenges.

AB - Recent clinical trials transparency initiatives signify laudable progress. Yet, a closer look on legal developments reveals that the protection of commercially confidential information and personal data continues to pose substantial challenges for drug innovation. This article depicts these developments with a particular focus on the European Medicines Agency (EMA) and biologics. We argue that to promote the development of innovative biologics and biosimilars, the EMA must carefully consider and address such challenges.

UR - https://www.ncbi.nlm.nih.gov/pubmed/30856292

U2 - 10.1002/ddr.21526

DO - 10.1002/ddr.21526

M3 - Journal article

C2 - 30856292

VL - 80

SP - 282

EP - 284

JO - Drug Development Research

JF - Drug Development Research

SN - 0272-4391

IS - 3

ER -

ID: 211818551