Patent and regulatory hurdles combined with low returns on investment are stifling antibiotic R&D in the pharmaceutical industry.
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References
Bad bugs, no drugs: as antibiotic R&D stagnates... a public health crisis brews (Infectious Diseases Society of America, Alexandria, Virginia, 2004).
Utility Examination Guidelines, 66 Fed. Reg. 1092 http://www.uspto.gov/web/officer/com/sol/notices/utilexmguide.pdf (2001).
Tufts Center for the Study of Drug Development pegs cost of a new prescription medicine at $802 million. http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=6 (2001).
Fermini, B. & Fossa, A.A. Nat. Rev. Drug Discov. 2, 439–447 (2003).
Harris, G. Approval of antibiotic worried safety officials. New York Times (19 July 2006).
FDA rejects Replidyne drug application. Denver Business Journal (23 October 2006).
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Katz, M., Mueller, L., Polyakov, M. et al. Where have all the antibiotic patents gone?. Nat Biotechnol 24, 1529–1531 (2006). https://doi.org/10.1038/nbt1206-1529
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DOI: https://doi.org/10.1038/nbt1206-1529
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