References
- AbbVie . 2017. “AbbVie Receives FDA Approval of MAVYRET® (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes.” Press Release, September 26. Accessed 3 December 2019. https://news.abbvie.com/news/press-releases/abbvie-receives-fda-approval-mavyret-glecaprevirpibrentasvir-to-shorten-treatment-duration-to-eight-weeks-for-treatment-nave-patients-with-chronic-hepatitis-c-and-compensated-cirrhosis-across-all-genotypes.htm .
- Andrews, M. 2017. “FDA's Approval Of A Cheaper Drug For Hepatitis C Will Likely Expand Treatment.” Shots, October 4. Accessed 3 December 2019. https://www.npr.org/ sections/health-shots/2017/10/04/555156577/fdas-approval-of-a-cheaper-drug-for-hepatitis-c-will-likely-expand -treatment.
- Benchoufi, M. , and P. Ravaud . 2017. “Blockchain Technology for Improving Clinical Research Quality.” Trials 18: 335. doi:10.1186/s13063-017-2035-z.
- Biosimilars Resource Center . 2017. “Biologics Price Competition and Innovation Act of 2009.” Academy of Managed Care Pharmacy, n.d. Accessed 6 December 2019. https://www. biosimilarsresourcecenter.org/ laws-regulations/federal-legislation-implementing-biosimilars-pathway/ biologics-price-competition-and-innovation-act-of-2009/.
- Challener, C. A. 2019. “FDA Marks Record for New Drug Approvals.” Pharmacy Technology 43 (1): 30–33.
- Deloitte . 2018. “Blockchain: A Technical Primer.” Insights, February 6. Accessed 8 December 2019. https://www2.deloitte.com/us/en/insights/topics/emerging-technologies/blockchain-technical-primer.html .
- Gatza, C. 2016. “Effects on Combination Products: The Biologics Price Competition and Innovation Act of 2009.” Carmango, October 13. Accessed 23 July 2020. https://camargo pharma.com/resources/blog/effects-on-combination-products-the-biologics-price-competition-and-innovation-act-of-2009/.
- Gottlieb, S. 2019. “Price Controls Would Stifle Biotech Innovation.” The Wall Street Journal, December 12, p. A19.
- IBM/KPMG/Merck/Walmart . 2020. FDA DSCSA: Blockchain Interoperability Pilot Project Report. February. Accessed 21 June 2020. https://www.ibm.com/downloads/cas/9V2L RYG5.
- Madden, B. J. 2018. Free to Choose Medicine: Better Drugs Sooner at Lower Prices . 3rd ed. Arlington Heights, IL : Heartland Institute.
- Myshko, D. 2017. “Trending 2018: Pipeline Disrupters.” Pharma Voice, November-December: 66–75.
- Myshko, D. 2018. “The Business of Biologics.” Pharma Voice, September. Accessed 24 November 2019. https://www.pharmavoice.com/article/2018-09-biologics/ .
- Pharmaphorum . 2018. “60% of Pharma Companies Using or Trying Blockchain – Survey.” September 28. Accessed 3 December 2019. https://pharmaphorum.com/news/60-of-pharma-companies-using-or-trying-blockchain-survey/ .
- Silverman, E. 2019. “Most State Medicaid Programs Continue to Restrict Access to Hepatitis C Medicines.” Stat+, October 16. Accessed 30 November 2019. https://www.statnews. com/pharmalot/2019/10/16/medicaid-hepatitis-access-drug-prices/.
- Timmis, R. 2015. “The Biologics Price Competition and Innovation Act: Potential Problems in the Biologic-Drug Regulatory Scheme.” Northwestern Journal of Technology and Intellectual Property 13 (2): 215–231.
- U.S. Food and Drug Administration . 2016. “Implementation of the Biologics and Price Competition and Innovation Act of 2009.” February 12. U.S. Food and Drug Administration 2016. Accessed 20 June 2020. https://www.fda.gov/drugs/ guidance-compliance-regulatory-information/implementation-biologics-price-competition-and-innovation-act-2009.
- U.S. Food and Drug Administration . 2019a. “Drug Approvals and Databases.” Accessed 5 December 2019. https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases .
- U.S. Food and Drug Administration . 2019b. “FDA Takes New Steps to Adopt More Modern Technologies for Improving the Security of the Drug Supply Chain Through Innovations that Improve Tracking and Tracing of Medicines.” Press Release, February 7. Accessed 21 June 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-adopt-more-modern-technologies-improving-security-drug-supply-chain-through .
- Walker, N. 2017. “Biologics: Driving Force in Pharma.” Pharma’s Almanac, June 5. Accessed 23 November 2019. https://www.pharmasalmanac.com/articles/biologics-driving-force-in-pharma .
- Zahreddine, M. 2018. “How Blockchain Will Revolutionize the Pharmaceutical Industry.” Forbes, November 14. Accessed 4 December 2018. https://www.forbes.com/sites/forbes techcouncil/2018/11/14/how-blockchain-will-revolutionize-the-pharmaceutical-industry/ #772766b126e5.