Now showing items 31-40 of 90
Data Exclusivity for Biologics
(Nature Reviews Drug Discovery, 2011-01)
The Role of Cost-Effectiveness Analysis in Managed Care Decisions
Entry and competition in generic biologics
(Managerial and Decision Economics, 2007-06-01)
Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologies can and should be treated like pharmaceuticals with regard to generics. In ...
The Determinants of Pharmaceutical Research and Development Expenditures
(Journal of Evolutionary Economics, 2000)
R&D Costs and Returns to New Drug Development: A Review of the Evidence
(The Oxford Handbook of the Economics of the Biopharmaceutical Industry, 2012-09-18)
© 2012 by Oxford University Press. All rights reserved.This article reviews the extensive literature on R&D costs and returns. The first section focuses on R&D costs and the various factors that have affected the trends ...
The roles of patents and research and development incentives in biopharmaceutical innovation.
(Health Aff (Millwood), 2015-02)
Patents and other forms of intellectual property protection play essential roles in encouraging innovation in biopharmaceuticals. As part of the "21st Century Cures" initiative, Congress is reviewing the policy mechanisms ...
Do Faster FDA Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act
times have significantly declined since the passage of PDUFA in 1992, while agency resources have expanded through user fees. After the recent withdrawal of Vioxx and other high-profile products, there have been increasing ...
R&D costs and returns by therapeutic category
(Drug Information Journal, 2004-09-03)
Objectives: This study examines the degree to which therapeutic class accounts for variability in drug development costs. It also scrutinizes how sales levels vary across the associated therapeutic classes for those drugs ...
Estimating the Effects of Regulation on Innovation: An International Comparative Analysis of the Pharmaceutical Industry
INNOVATION in the U.S. ethical drug industry in recent years has been characterized by a number of adverse developments. In particular, there has been a sharp decline in the rate of new product introductions and the incentive ...
Patents and New Product Development in the Pharmaceutical and Biotechnology Industry
(The Georgetown Public Policy Review, 2003-03)