Novel Drug Movers and Shakers 2013-2016

Small and Medium Sized Companies in North America Lead Novel Drug Innovation

Small and medium sized companies and academia are important drivers of innovation in drug development. To investigate the profile of the organisations originating and developing novel drugs approved in the EU and US during 2013-2016 we have compiled all medicinal products containing novel substances (e.g. NAS, NME and Biologics) from the EMA and FDA websites.

For each novel drug we mapped the approval pathway, rare disease (orphan) status and post-approval licensee. The innovator(s and the development organisation(s) were mapped in accordance with the ADIS insights database. Each originator and developer was categorised as a large pharmaceutical company, a small or medium sized pharmaceutical company (SME) or an academic and/or public body.

We also mapped and analysed the geographical origin (e.g. Europe, North America or Rest of the World) of the SME or the academic and/or public body. Altogether, 178 novel drugs received approval from the EMA and/or the FDA during 2013-2016.

To read the White Paper written by Dr Terese Johansson, Regulatory Affairs Consultant NDA Group click here.








Dr Terese Johansson, Regulatory Affairs Consultant NDA Group