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July 2017

Features

The Agency Wants to Use Manufacturing Data to Attack Drug Shortages
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.
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.
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
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
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!
Prescription: Washington
A significant change in tiering exceptions policy for Part D is coming in 2018
Approvals, new indications, regulatory activities, and more
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) for the treatment of irritable bowel syndrome with diarrhea