Background The concept of health care innovation varies across organizations and
countries. Harmonizing the definitions of innovation can augment the discovery of new …

Biotechnology and small pharma companies must recognize the opportunity presented by
FDA Breakthrough Therapy Designation (BTD) to expedite drug development for serious …

This analysis explores the impact of the FDA's orphan drug designation (ODD) on
biotechnology companies' share prices in the short and long term. Our analysis reveals that …

© 2019 Portfolio Management Research. All rights reserved. Thanks to a combination of
scientific advances and economic incentives, the development of therapeutics to treat rare or …

Can regulation reduce risks associated with investing in early-stage firms? Using the
passage of the European Orphan Drug Act (EU-ODA), we examine this question in the …

With the COVID-19 pandemic, governments around the globe discovered the vulnerability of
the pharma supply chains (PSCs). In this review, we describe the nature of disruptions that …

En pleine pandémie de COVID-19, cet article questionne le brevet en tant qu'architecture
institutionnelle destinée à établir un équilibre entre protection et diffusion de l'innovation, à …

This research examines the impact of the US FDA's Regenerative Medicine Advanced
Therapy (RMAT) designation on biotechnology and small pharmaceutical companies …

The pharmaceutical industry is controversially discussed. Nevertheless, there is a con-
sensus that the need for new medicines is undeniable. In particular, the treatment of rare …

The pharmaceutical industry is controversially discussed. Nevertheless, there is a con-
sensus that the need for new medicines is undeniable. In particular, the treatment of rare …