BREAKING NEWS

Latest failure brings amyloid hypothesis into question
Guidance published on how to best design coverage for treatment of the smallest, most vulnerable victims of the opioid crisis
Agency plans to respond after receipt of letter of concern
Continuous nerve stimulation helps to alleviate withdrawal symptoms
Polypharmacy, including both prescription and OTC drugs, increase risk
Agent decreases the chance of infection due to chemo-induced febrile neutropenia
But some in industry disagree with the idea
Newer data and statistical methods can improve diagnosis and prescribing
A modified form of adoptive cell transfer targets mutations
Drug now approved for moderately to severely active ulcerative colitis

P&T June 2018
Table of Contents

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

P&T TV

Perspectives on the Opioid Crisis With Dr. David B. Nash

Dr. David B. Nash, Dean of the Jefferson College of Population Health, talks about the national opioid emergency with Lyn Chesna, Managing Editor of P&T. Dr. Nash describes how population health professionals, big pharma, and nonprofit organizations, such as the 1889 Foundation and the Pharmacy Quality Alliance, are addressing the issue. 

April 2018 interview