Now showing items 1-10 of 13
The cost of drug development.
(N Engl J Med, 2015-05-14)
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 ...
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 ...
Should the patent system for new medicines be abolished?
(Clin Pharmacol Ther, 2007-11)
The distribution of sales revenues from pharmaceutical innovation.
OBJECTIVE: This report updates our earlier work on the returns to pharmaceutical research and development (R&D) in the US (1980 to 1984), which showed that the returns distributions are highly skewed. It evaluates a more ...
The price of innovation: new estimates of drug development costs.
(J Health Econ, 2003-03)
The research and development costs of 68 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug development. The costs of ...
Economic return of clinical trials performed under the pediatric exclusivity program.
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 ...
Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention.
(Cancer Prev Res (Phila), 2008-07)
Chemoprevention agents are an emerging new scientific area that holds out the promise of delaying or avoiding a number of common cancers. These new agents face significant scientific, regulatory, and economic barriers, however, ...
Returns to R&D on new drug introductions in the 1980s.
(J Health Econ, 1994-12)
This study finds that the mean IRR for 1980-84 U.S. new drug introductions is 11.1%, and the mean NPV is 22 million (1990 dollars). The distribution of returns is highly skewed. The results are robust to plausible changes ...
Spending on postapproval drug safety.
(Health Aff (Millwood), 2006-03)
Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding ...