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Medical Innovation Then and Now: Perspectives of Innovators Responsible for Transformative Drugs

Published online by Cambridge University Press:  01 January 2021

Shuai Xu  and
Aaron S. Kesselheim
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Extract

The discovery and development of new therapeutics has always been central to improving health worldwide. However, there is ongoing concern regarding the current state of medical innovation. Output from the pharmaceutical industry has been criticized for not being “transformative,” that is, offering substantial improvements in patient outcomes over existing therapeutics. While the cost of drug development continues to rise, breakthrough therapies remain elusive and one half of Phase 3 studies fail. Venture capital, a traditional source of funding for new breakthrough biomedical innovations, has decreased investment by 30% in the biotechnology and medical device sectors from 2007 to 2013. Stakeholders question whether the new drugs approved each year by the FDA —many criticized as marginal improvements over existing therapies — justify the enormous investment.

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Independent
Information
Journal of Law, Medicine & Ethics , Volume 42 , Issue 4 , Winter 2014 , pp. 564 - 575
Copyright
Copyright © American Society of Law, Medicine and Ethics 2014

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