BREAKING NEWS

FDA Approves First Generic Versions of Suboxone Sublingual Film
However, patent dispute will delay one launch
Study: With FDA Input, Compassionate Use Programs Appear to Work Well
Some experts still opposed to “right to try” treatments
Moxidectin Receives FDA Approval for the Treatment of River Blindness
Approval acquired through tropical disease priority review voucher program
Valeant Hit With CRL for Key Dermatology Drug
FDA questioning the pharmacokinetics of psoriasis lotion Duobrii
Keytruda Scores New Indication for Specific Refractory or Relapsed Non-Hodgkin’s Lymphoma
Therapy approved for adults and children with refractory PMBCL or who have relapsed after two or more prior lines of therapy
Lilly, AstraZeneca Pull the Plug on Alzheimer's Trials
Latest failure brings amyloid hypothesis into question
CMS Urges States to Better Utilize Medicaid to Treat Opioid-Addicted Infants
Guidance published on how to best design coverage for treatment of the smallest, most vulnerable victims of the opioid crisis
House Panel Questions FDA's Track Record Combating Illegal Opioids
Agency plans to respond after receipt of letter of concern
FDA Clears Wearable Device to Treat Opioid Addiction
Continuous nerve stimulation helps to alleviate withdrawal symptoms
Study: One-Third of U.S. Adults May Unknowingly Use Medications That Can Cause Depression
Polypharmacy, including both prescription and OTC drugs, increase risk

P&T June 2018
Table of Contents

Features

Congress Moves Toward Opioid Response 2.0
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.
Big Data and Pharmacovigilance: Data Mining for Adverse Drug Events and Interactions
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.
Comparative Review of Oral P2Y12 Inhibitors
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
Targeting Remission in Moderate-to-Severe Crohn’s Disease
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
The International Liver Congress 2018
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

Medication Errors
Accidental Overdoses Involving Fluorouracil Infusions
Prescription: Washington
FDA to Collect Patient Experience Data
Upcoming Guidance Documents Will Spell Out What and How to Submit
Drug and Device News June 2018
Approvals, new indications, regulatory activities, and more
Pharmaceutical Approval Update June 2018
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)
Valbenazine (Ingrezza): the first FDA-approved treatment for tardive dyskinesia
Research Briefs June 2018

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