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