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June 2018

Features

Bills Are Wide Ranging and Well Intentioned but Mostly Lightweight
Although some aspects of the opioid epidemic, such as physician overprescribing, have lessened in the past few years, the overdose death rate continues to climb. The author describes the latest federal actions aimed at tackling the crisis.
Data mining electronic sources, including adverse event reports, medical literature, electronic health records, and social media, has been successful in identifying new drug–adverse drug event associations for drug safety surveillance purposes. We explore the use of “big data” and how it is contributing to pharmacovigilance efforts.
Current practice guidelines recommend dual antiplatelet therapy comprised of aspirin and a purinergic signaling receptor Y12 (P2Y12) for patients following acute coronary syndrome. This article compares the efficacy, safety, and other characteristics of the three available oral P2Y12 inhibitors—clopidogrel, prasugrel, and ticagrelor.
Pipeline Plus
Therapeutic options in development for the treatment of Crohn’s disease represent a broad range of approaches to this complex disease. This active pipeline contains a combination of both small-molecule entities and targeted monoclonal antibodies.
Meeting Highlights
Our coverage of this year’s International Liver Congress reviews sessions on hepatitis C, primary biliary cholangitis, nonalcoholic steatohepatitis, homozygous familial hypercholesterolemia, and advanced hepatocellular carcinoma.

Departments

Prescription: Washington
Upcoming Guidance Documents Will Spell Out What and How to Submit
Approvals, new indications, regulatory activities, and more
Burosumab-twza (Crysvita) for a rare inherited form of rickets; ibalizumab-uiyk (Trogarzo) for human immunodeficiency virus type 1 infection; and tildrakizumab-asmn (Ilumya) for adults with moderate-to-severe plaque psoriasis
Drug Forecast
Valbenazine (Ingrezza): the first FDA-approved treatment for tardive dyskinesia