BREAKING NEWS

FDA Approves Opdivo Plus Yervoy Combination for Certain Renal Cell Carcinoma
Regimen showed significant improvement in overall survival in trial versus Sutent
Pradaxa Reversal Agent Praxbind Receives Full FDA Approval
Drug is first and only approved specific reversal agent for a novel oral anticoagulant
FDA Approves Artificial Intelligence-Based Device to Detect Certain Diabetes-Related Eye Problems
Test performed in the primary care setting may improve access to screening
Study: As Cancer Drug Prices Climb, Value Not Keeping Pace
Researchers found no association between clinical value and cost
FDA Clears First Contact Lens With Light-Adaptive Technology
Lenses automatically darken in bright light
FDA OKs Second Ovarian Cancer Indication for PARP Inhibitor Rubraca
Agent is now approved for the maintenance treatment of recurrent disease regardless of BRCA status
FDA Restricts Sale and Distribution of Essure Contraception Device
Agency aims to ensure women are properly informed of the risks
Researchers Propose New Alzheimer’s Definition Based on Biology
Approach would allow for drug testing in patients before clinical symptoms appear
Duobrii Produces Positive Phase 3 Results in Psoriasis Treatment
Product would be the first lotion to combine halobetasol and tazarotene in one formulation
Keytruda Scores Another Win in Phase 3 Lung Cancer Study
Monotherapy significantly improved overall survival as first-line therapy in certain NSCLC patients

P&T April 2018
Table of Contents

Features

Frustration Over Generic Drug Shortages and Prices Prompts Federal and Private Actions
Health Systems Take Matters Into Their Own Hands
Generic shortages are draining hospital resources throughout the U.S. and in some cases imperiling inpatient treatment. The author considers the FDA’s performance and describes the approach some health systems are taking to create a solution.
Pharmacological Agents Utilized in Patients With Type-2 Diabetes: Beyond Lowering A1c
Staying up to date with evolving pharmacotherapies is important to providing optimal therapies to patients. The authors present available evidence to support the role of novel and existing agents in treating type-2 diabetes.
Management and Preventive Measures for Febrile Neutropenia
The authors briefly review febrile neutropenia, describe risk assessment tools, and discuss treatment and prophylactic options for this serious complication.
Pipeline Plus
Intense Focus Yet Many Setbacks for Alzheimer’s Disease Drug Development
Despite failures in late-phase trials, the pipeline of medications for Alzheimer’s disease is robust as companies hope to be the first to bring an effective therapy to market. We review several investigational agents in late-stage development.

Departments

Medication Errors
Severe Harm and Death Associated With Errors and Drug Interactions Involving Low-Dose Methotrexate
Harm and death associated with methotrexate errors
Prescription: Washington
CMS Consideration of Rebate Overhaul Elicits Strong Opinions Both Pro and Con
CMS consideration of rebate overhaul elicits strong opinions
Drug and Device News April 2018
Approvals, new indications, regulatory activities, and more
Pharmaceutical Approval Update April 2018
Netarsudil ophthalmic solution (Rhopressa) for the reduction of elevated intraocular pressure; ertugliflozin (Steglatro) for adults with type-2 diabetes; and lutetium lu 177 dotatate (Lutathera) for certain gastroenteropancreatic neuroendocrine tumors
Drug Forecast
Plecanatide (Trulance) for Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
Plecanatide (Trulance) for chronic idiopathic constipation and irritable bowel syndrome with constipation
Research Briefs April 2018