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Economics of new oncology drug development.
(J Clin Oncol, 2007-01-10)
PURPOSE: Review existing studies and provide new results on the development, regulatory,
and market aspects of new oncology drug development. METHODS: We utilized data from
the US Food and Drug Administration (FDA), company ...
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 ...
Should the patent system for new medicines be abolished?
(Clin Pharmacol Ther, 2007-11)
Generic competition and market exclusivity periods in pharmaceuticals
(Managerial and Decision Economics, 2007-06-01)
In this paper we examine generic competition and market exclusivity periods for pharmaceuticals
experiencing their initial generic entry between 1995 and 2005. We find that generic
competition has increased over several ...
The cost of biopharmaceutical R&D: Is biotech different?
(Managerial and Decision Economics, 2007-06-01)
The costs of developing the types of new drugs that have been pursued by traditional
pharmaceutical firms have been estimated in a number of studies. However, similar
analyses have not been published on the costs of developing ...
Economic return of clinical trials performed under the pediatric exclusivity program.
(JAMA, 2007-02-07)
CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to
grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program
if industry sponsors complete FDA-requested pediatric ...
Competition between Generic and Branded Drugs
(Pharmaceutical innovation: incentives, competition, and cost-benefit analysis in international
perspective, 2007-04-30)
The pharmaceutical industry worldwide is a rapidly burgeoning industry contributing
to growth of gross domestic product and employment. Technological change in this field
has been very rapid, with many new products being ...