Journal ArticleInternational Journal of the Economics of Business · May 3, 2016
Human blood plasma and its derivative therapies have been used therapeutically for more than 50 years, after first being widely used to treat injuries during World War II. In certain countries, manufacturers of these therapies – known as plasma-derived med ...
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Journal ArticleJournal of health economics · May 2016
The research and development costs of 106 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 and biologics development. The costs of compounds abandoned ...
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Journal ArticleHealth affairs (Project Hope) · February 2015
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 designed to accelerate the discove ...
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Journal ArticleHealth affairs (Project Hope) · June 2014
In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market curren ...
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Journal ArticleFood and drug law journal · January 2012
This article examines how the nature of competition between brands in a therapeutic category changes after generic entry and provide a framework for analyzing the effect of generic entry on consumer welfare that takes into account the generic free riding p ...
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Journal ArticleHealth affairs (Project Hope) · November 2011
The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. Generic drug usage and chall ...
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Journal ArticleInternational Journal of the Economics of Business · May 3, 2016
Human blood plasma and its derivative therapies have been used therapeutically for more than 50 years, after first being widely used to treat injuries during World War II. In certain countries, manufacturers of these therapies – known as plasma-derived med ...
Full textOpen AccessCite
Journal ArticleJournal of health economics · May 2016
The research and development costs of 106 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 and biologics development. The costs of compounds abandoned ...
Full textOpen AccessCite
Journal ArticleHealth affairs (Project Hope) · February 2015
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 designed to accelerate the discove ...
Full textOpen AccessCite
Journal ArticleHealth affairs (Project Hope) · June 2014
In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market curren ...
Full textOpen AccessCite
Journal ArticleFood and drug law journal · January 2012
This article examines how the nature of competition between brands in a therapeutic category changes after generic entry and provide a framework for analyzing the effect of generic entry on consumer welfare that takes into account the generic free riding p ...
Open AccessCite
Journal ArticleHealth affairs (Project Hope) · November 2011
The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. Generic drug usage and chall ...
Full textOpen AccessCite
Journal ArticleAm Heart J · October 2008
BACKGROUND: Congress has authorized the United States Food and Drug Administration (FDA) to provide industry sponsors with a 6-month extension of drug marketing rights under the Pediatric Exclusivity Provision if FDA-requested pediatric drug trials are con ...
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Journal ArticleJournal of Law and Economics · May 1, 2008
Food and Drug Administration (FDA) review times have significantly declined under the user-fee regime. This situation has provoked concerns that drug safety has been adversely affected. Combining information from several comprehensive databases, we analyze ...
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Journal ArticleJournal of health politics, policy and law · April 2008
The review essay by Donald Light about a Congressional Budget Office report on pharmaceutical research and development (R&D) (Light 2007) contains factual errors, leaves the reader uninformed about rebuttal responses to criticisms made in the review about ...
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Chapter · January 1, 2008
This book provides an insightful view of major issues in the economics of corporate governance (CG) and mergers. It presents a systematic update on the developments in the two fields during the last decade, as well as highlighting the neglected topics in C ...
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Journal ArticleManagerial and Decision Economics · June 1, 2007
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 contrast with pharmaceuticals, which ...
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Journal ArticleManagerial and Decision Economics · June 1, 2007
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 the types of molecules on whi ...
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Journal ArticleManagerial and Decision Economics · June 1, 2007
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 dimensions. First, an increasing num ...
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Chapter · April 30, 2007
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 introduced. For this reason in part ...
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Journal ArticleJAMA · February 7, 2007
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 trials. The program has been pra ...
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Journal ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology · January 2007
PurposeReview existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development.MethodsWe utilized data from the US Food and Drug Administration (FDA), company surveys, and public ...
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Journal ArticleHealth affairs (Project Hope) · March 2006
We examined trends in the introduction of new chemical entities (NCEs) worldwide from 1982 through 2003. Although annual introductions of NCEs decreased over time, introductions of high-quality NCEs (that is, global and first-in-class NCEs) increased moder ...
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Journal ArticleEconomics and Politics · March 1, 2006
We examine the major interest groups in the debate over allowing the re-importation of prescription drugs by utilizing a logit model and instrumental variables. Consistent with political support approach, the evidence suggests that Representatives are maxi ...
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Journal ArticleHealth Aff (Millwood) · 2006
Infectious and parasitic diseases create enormous health burdens, but because most of the people suffering from these diseases are poor, little is invested in developing treatments. We propose that developers of treatments for neglected diseases receive a ...
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Journal ArticleHealth Aff (Millwood) · 2006
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 safety efforts. Mean spending on ...
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Chapter · 2005
Distinguished economists, political scientists, and legal experts discuss the implications of the increasingly globalized protection of intellectual property rights for the ability of countries to provide their citizens with such important public goods as ...
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Journal ArticlePharmacoEconomics · 2004
Pharmaceutical R&D competition in the 1980s
and 1990s was
characterized by rising R&D expenditures,
favorable returns
to innovators, and the introduction of many
new classes of
drugs with high social benefits. However
in the past
three years the num ...
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Journal ArticleJournal of health economics · March 2003
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 compounds abandoned during testing ...
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Journal ArticlePharmacoEconomics · January 2000
ObjectiveThis 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 recent cohort of new drug in ...
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Journal ArticleInternational Journal of Technology Management · January 1, 2000
Effective patent life is lost in pharmaceuticals because of the lengthy time periods required for clinical trials and regulatory approval. A 1984 US law restores some of this lost patent time, while also facilitating generic competition when patents expire ...
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Journal ArticleJournal of health economics · December 1994
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 in the baseline assumptions. Our w ...
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Journal ArticlePharmacoEconomics · January 1992
This study expands our previous work on the availability of new drug introductions to poor patients in states in the USA with restrictive Medicaid formularies. In particular, it focuses on the experience of 9 states over the period 1979 to 1985. In these ...
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Journal ArticleJournal of health economics · July 1991
The research and development costs of 93 randomly selected new chemical entities (NCEs) were obtained from a survey of 12 U.S.-owned pharmaceutical firms. These data were used to estimate the pre-tax average cost of new drug development. The costs of aband ...
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Chapter · 1991
With an ever-increasing number of liability lawsuits, are corporations electing to play it safe rather than risk the uncertainties accompanying innovation? In The Liability Maze experts address the issues surrounding safety and innovation and present the m ...
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Journal ArticleAmerican Economic Review · January 1, 1978
While it is still too early to evaluate con- clusively the recent wave of consumer product safety regulation, the evidence thus far indicates that serious resource mis- allocation is taking place and is likely to continue. The regulators of product safety ...
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