LAUSR

Graphical abstract Figure. No caption available. HighlightsThe FDA approved a total of 251 NMEs and 67 biologics during 2006–2016.Pre‐approval publications can provide insight on the innovation ecosystem.Text mining identifies major research contributions of each organization.Sponsors authored only about 14% of publications on approved and failed drugs.Drug candidate success benefits from a combined effort of academia and industry. ABSTRACT Pharmaceutical companies are relying more often on external sources of innovation to boost their discovery research productivity. However, more in‐depth knowledge about how external innovation may translate to successful product launches is still required in order to better understand how to best leverage the innovation ecosystem. We analyzed the pre‐approval publication histories for FDA‐approved new molecular entities (NMEs) and new biologic entities (NBEs) launched by 13 top research pharma companies during the last decade (2006–2016). We found that academic institutions contributed the majority of pre‐approval publications and that publication subject matter is closely aligned with the strengths of the respective innovator. We found this to also be true for candidate drugs terminated in Phase 3, but the volume of literature on these molecules is substantially less than for approved drugs. This may suggest that approved drugs are often associated with a more robust dataset provided by a large number of institutes. Collectively, the results of our analysis support the hypothesis that a collaborative research innovation environment spanning across academia, industry and government is highly conducive to successful drug approvals.