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REFERENCES 1 US Food and

REFERENCES 1 US Food and Drug Administration. Novel drugs 2015. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ DrugInnovation/UCM485053.pdf. Published January 2016. Accessed March 2016. 2 US Food and Drug Administration. 2015 biological license application approvals. http://www.fda.gov/BiologicsBloodVaccines/ DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm434961.htm. Published January 14, 2016. Accessed March 2016. 3 US Food and Drug Administration. Novel drugs 2015. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ DrugInnovation/UCM485053.pdf. Published January 2016. Accessed March 2016. 4 US Food and Drug Administration. FDA approves Cotellic as part of combination treatment for advanced melanoma. http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm471934.htm. Published November 10, 2015. Accessed March 2016. 5 US Food and Drug Administration. FDA approves first-of-its-kind product for the treatment of melanoma. http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm469571.htm. Published October 27, 2015. Accessed March 2016. 6 US Food and Drug Administration. FDA approves Nucala to treat severe asthma. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm471031.htm. Published November 4, 2015. Accessed March 2016. 7 US Food and Drug Administration. FDA approves two new drug treatments for diabetes mellitus. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm464321.htm. Published September 25, 2015. Accessed March 2016. 8 Novo Nordisk. Novo Nordisk receives US FDA approval for Tresiba ® and Ryzodeg ® 70/30. http://www.novonordisk.com/content/Denmark/ HQ/www-novonordisk-com/en_gb/home/media/news-details.1954709.html. Published September 25, 2015. Accessed March 2016. 9 US Centers for Disease Control and Prevention. National diabetes fact sheet, 2011. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed March 2016. 10 US Food and Drug Administration. FDA approves new drug to treat schizophrenia and bipolar disorder. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm463103.htm. Published September 17, 2015. Accessed March 2016. 11 US Food and Drug Administration. FDA approves new injectable drug to treat schizophrenia. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm465801.htm. Published October 6, 2015. Accessed March 2016. 12 Alkermes. FDA approves ARISTADA for treatment of schizophrenia. http://phx.corporate-ir.net/phoenix.zhtml?c=92211&p=irol-corpor ateNewsArticle&ID=2094281. Published October 5, 2015. Accessed March 2016. 13 Robinson JG. Management of familial hypercholesterolemia: A review of the recommendations from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Manag Care Pharm. 2013;19(2):139–149. 14 The FH Foundation. About HoFH. https://thefhfoundation.org/about-fh/homozygous-familial-hypercholesterolemia. Accessed March 2016. 15 US Food and Drug Administration. FDA approves Praluent to treat certain patients with high cholesterol. http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm455883.htm. Published July 24, 2015. Accessed March 2016. 16 US Food and Drug Administration. FDA approves Repatha to treat certain patients with high cholesterol. http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm460082.htm. Published August 27, 2015. Accessed March 2016. 17 American Heart Association. Heart disease and stroke statistics—2015 update: A report from the American Heart Association. http://circ.ahajournals.org/content/131/4/e29.extract. Accessed March 2016. 18 US Food and Drug Administration. FDA approves Corlanor to treat heart failure. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm442978.htm. Published April 15, 2015. Accessed March 2016. 19 US Food and Drug Administration. FDA approves new drug to treat heart failure. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm453845.htm. Published July 7, 2015. Accessed March 2016. 20 US Food and Drug Administration. Novel new drug summaries (2011-2015): Calculated average from each report’s data. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm. Accessed April 2016. 21 US Food and Drug Administration. Novel drugs 2015. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ DrugInnovation/UCM485053.pdf. Published January 2016. Accessed March 2016. 14 Improving the Lives of Patients

22 US Food and Drug Administration. FDA approves Darzalex for patients with previously treated multiple myeloma. http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm472875.htm. Published November 16, 2015. Accessed March 2016. 23 US Food and Drug Administration. FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma. http://www. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474684.htm. Published November 30, 2015. Accessed March 2016. 24 US Food and Drug Administration. Novel Drugs 2015. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ DrugInnovation/UCM485053.pdf. Published January 2016. Accessed March 2016. 25 US Food and Drug Administration. FDA approves new treatment for cystic fibrosis. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm453565.htm. Published July 2, 2015. Accessed March 2016. 26 US Food and Drug Administration. FDA approves new treatment for cystic fibrosis. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm453565.htm. Published July 2, 2015. Accessed March 2016. 27 US Food and Drug Administration. FDA approves new treatment for rare metabolic disorder. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm468836.htm. Published October 23, 2015. Accessed March 2016. 28 US Food and Drug Administration. FDA approves first therapy for high-risk neuroblastoma. http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm437460.htm. Published March 10, 2015. Accessed March 2016. 29 US Food and Drug Administration. FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients. http://www. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476013.htm. Published December 8, 2015. Accessed March 2016. 30 US Food and Drug Administration. FDA approves new orphan drug to treat rare autosomal recessive disorder. http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm457867.htm. Published September 4, 2015. Accessed March 2016. 31 US Food and Drug Administration. FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476013.htm. Published December 8, 2015. Accessed March 2016. 32 US Centers for Disease Control and Prevention. Vital signs: Avoidable deaths from heart disease, stroke, and hypertensive disease— United States, 2001–2010. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6235a4.htm. Published September 6, 2013. Accessed March 2016. 33 Towfighi A, Saver JL. Stroke declines from third to fourth leading cause of death in the United States: Historical perspective and challenges ahead. Stroke. 2011;42(8):2351-55. 34 Schober SE, Carroll MD, Lacher DA, Hirsch R. High serum total cholesterol—An indicator for monitoring cholesterol lowering efforts: US Adults, 2005–2006. NCHS Data Brief. 2007;(2):1-8. 35 PhRMA. A decade of innovation in chronic diseases: 2006–2016. http://phrma.org/sites/default/files/pdf/decade-of-innovation-chronicdisease.pdf. Published 2016. Accessed March 2016. 36 American Cancer Society. Cancer facts & figures, 2016. http://www.cancer.org/acs/groups/content/@research/documents/document/ acspc-047079.pdf. Published 2016. Accessed March 2016. 37 American Association for Cancer Research. AACR cancer progress report 2013. http://cancerprogressreport.org/2013/ Documents/2013_AACR_CPR_FINAL.pdf. Published 2013. Accessed March 2016. 38 Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. http://onlinelibrary.wiley.com/doi/10.3322/caac.21332/full. Published January 7, 2016. Accessed March 2016. 39 American Cancer Society. Cancer facts & figures, 2016. http://www.cancer.org/acs/groups/content/@research/documents/document/ acspc-047079.pdf. Published 2016. Accessed March 2016. 40 Druker BJ, Guilhot F, O'Brien SG, et al. Five-year follow-up of patients receiving Imatinib for chronic myeloid leukemia. N Engl J Med. 2006;355:2408–17. 41 US Centers for Disease Control and Prevention. Surveillance for viral hepatitis—United States 2013. http://www.cdc.gov/hepatitis/ statistics/2013surveillance/commentary.htm. Accessed March 2016. 42 US Food and Drug Administration. Package insert PEG-Intron (Peginterferon alfa-2b). http://www.accessdata.fda.gov/drugsatfda_ docs/ label/2001/pegsche080701LB.htm. Accessed December 2015. 43 PhRMA. A decade of innovation in chronic diseases: 2006–2016. http://phrma.org/sites/default/files/pdf/decade-of-innovation-chronicdisease.pdf. Published 2016. Accessed March 2016. Improving the Lives of Patients 15

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