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Orphan Drugs and Their Impact on Pharmaceutical Development
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för neurovetenskap, Funktionell farmakologi.
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för immunologi, genetik och patologi, Medicinsk genetik och genomik.
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för neurovetenskap, Funktionell farmakologi.ORCID-id: 0000-0001-7112-0921
2018 (engelsk)Inngår i: TIPS - Trends in Pharmacological Sciences, ISSN 0165-6147, E-ISSN 1873-3735, Vol. 39, nr 6, s. 525-535Artikkel, forskningsoversikt (Fagfellevurdert) Published
Abstract [en]

High levels of productivity, with an increasing number of approvals for new molecular entities (NMEs) by the FDA during the past decade, have coincided with the emergence of innovative drugs for treatments of rare diseases that have utilized the FDA orphan drug program. Since 2000, NMEs with orphan designation encompass a significant portion of approved drugs and constitute about 80% of the approved drugs that have established novel human genome-encoded products in recent years. Biological approvals are also expanding, with 40% of the approved biological agents having orphan designation. This trend illustrates a pivot within the pharmaceutical industry: from research programs that focus on canonical blockbuster indications and targets, towards the establishment of new treatments for rare and difficult to treat diseases.

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2018. Vol. 39, nr 6, s. 525-535
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URN: urn:nbn:se:uu:diva-358124DOI: 10.1016/j.tips.2018.03.003ISI: 000432349900001PubMedID: 29779531OAI: oai:DiVA.org:uu-358124DiVA, id: diva2:1241806
Tilgjengelig fra: 2018-08-24 Laget: 2018-08-24 Sist oppdatert: 2019-03-15bibliografisk kontrollert

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