BREAKING NEWS

AstraZeneca Reports “Disappointing” Results From MYSTIC Lung Cancer Trial
Durvalumab/tremelimumab combo fails to improve PFS compared to chemotherapy
FDA Approves Fycompa for Use as Monotherapy in Some Epilepsy Cases
Eisai is first to take advantage of new FDA regulatory pathway
Celgene Settles Case Alleging Marketing Violations for $280 Million
Violations focused on promotion of Thalomid and Revlimid
Global Biosimilars Market Expected to Reach $ 36 Billion by 2020
U.S. poses challenges for biosimilars, consultant argues
Child Living With HIV Maintains Remission Without Drugs Since 2008
9-year-old treated for 40 weeks in infancy is the third such reported case
Poison Control Centers Got 275,000 Dietary Supplement Calls From 2000 to 2012
Researchers suggest FDA regulation of yohimbe and energy products
Stopping a Cholesterol-Lowering Drug Due to Aches and Pains May Be Dangerous in the Long Run
Patients who discontinue statins increase their risk for death, heart attack, or stroke
Small Drop in U.S. Measles Vaccinations Would Have Outsized Effect
A 5% drop would cause annual measles cases to triple, according to study
New Zika Testing Recommendation Issued for Pregnant Women
Declining cases of infection and limitations of the blood test prompt revision
Merck’s Biosimilar Debuts at a 35% List Price Discount to Remicade
Renflexis also costs 20% less than a biosimilar already on the market

P&T TV

SIRT for Liver Cancer: Similar Efficacy, Less Toxicity Than Sorafenib

Valérie Vilgrain, MD, of Hôpital Beaujon Service de Radiologie in Paris, describes results of the SARAH trial. Selective internal radiation therapy provided efficacy similar to sorafenib for hepatocellular carcinoma but with considerably fewer adverse events.

European Association for the Study of the Liver International Liver Congress, April 2017

P&T July 2017
Table of Contents

Features

Letter to the Editor
Continuing the Debate: Branko Furst’s Alternative Model And the Role of the Heart
Drug Industry Groups Oppose FDA “Quality Metrics” Plan
Raising their voices in nearly unanimous opposition, pharmaceutical manufacturers and their suppliers have mounted a campaign to dissuade the FDA from launching a voluntary program in 2018 that is aimed at reducing drug shortages.
Cancer Immunotherapy, Part 2: Efficacy, Safety, and Other Clinical Considerations
This article, the second in a series of three, provides an overview of the efficacy and safety of cancer immunotherapies ranging from monoclonal antibodies to vaccines, including additional clinical considerations regarding immune checkpoint blockers.
Heart Failure: A Class Review of Pharmacotherapy
A recent guideline update for the treatment of heart failure has created the need for a new look at the medication classes and trials related to the disease. The authors focus on pharmacological options available for treating the problem.
Pharmacovigilance Forum
Drug-Induced QT Prolongation And Torsades de Pointes
Torsades de pointes (TdP)—an uncommon but life-threatening polymorphic ventricular tachycardia—is almost always drug induced. The authors describe the causes, risk factors, symptoms, diagnosis, and treatment of TdP.
Meeting Highlights
Seeking Solutions to the Opioid Crisis
At an event focusing on population-health approaches to the opioid epidemic, discussants agreed that better coordination of care, community involvement in finding solutions, and more consistent use of improved pain-control options are required.

Departments

Medication Errors
Strengthen Your Resolve: No Unlabeled Containers Anywhere, Ever!
Strengthen your resolve: no unlabeled containers anywhere, ever!
Prescription: Washington
Significant Change Coming in 2018 in Tiering Exceptions Policy for Part D
A significant change in tiering exceptions policy for Part D is coming in 2018
Drug and Device News July 2017
Approvals, new indications, regulatory activities, and more
Pharmaceutical Approval Update July 2017
Niraparib (Zejula) for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; ocrelizumab (Ocrevus) for relapsing or primary progressive multiple sclerosis; and dupilumab (Dupixent) for moderate-to-severe atopic dermatitis
Drug Forecast
Eluxadoline (Viberzi)
Eluxadoline (Viberzi) for the treatment of irritable bowel syndrome with diarrhea
Research Briefs July 2017