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P&T December 2014

Features

The FDA Is Struggling to Ground Them

The prices of some generic pharmaceuticals have lifted off into the stratosphere. A variety of reasons account for the increases, including loss of competition, dropping of product lines, and delays at the Food and Drug Administration.

Stem cell therapies offer great promise for a wide range of diseases and conditions. However, stem cell research—particularly human embryonic stem cell research—has also been a source of ongoing ethical, religious, and political controversy.

No agents are approved to reverse the effects of newer anticoagulants used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. This review focuses on ways to monitor, interrupt, and reverse such anticoagulation.

Antidiabetic agents can be delivered orally or with a syringe, but other options are also available, such as insulin and non-insulin pen devices and insulin pumps. This article reviews the available delivery devices and their current place in therapy.

Departments

Medication Errors

Another tragic parenteral nutrition compounding error

FDA approvals, drug indications, and updates

Ledipasvir/sofosbuvir (Harvoni) for hepatitis C virus genotype 1 infection; dulaglutide (Trulicity) for glycemic control in type-2 diabetes; netupitant/palonosetron (Akynzeo) for prevention of nausea and vomiting related to chemotherapy; and naloxegol (Movantik) for opioid-induced constipation in patients with chronic noncancer pain

Drug Forecast

Ceftolozane/tazobactam: a new option in the treatment of complicated gram-negative infections

Meeting Highlights

Sessions covered metastatic breast cancer, cachexia in non–small-cell lung cancer, recurrent and/or metastatic head and neck squamous-cell carcinoma, and melanoma.

Pipeline Plus

Global prevalence of type-2 diabetes is expected to reach 330 million cases by 2022, with medication sales of $67.7 billion. The market is crowded with generic medications, and most products now in the development pipeline are “me-too” drugs.