BREAKING NEWS

FDA Approves Duzallo for Hyperuricemia in Uncontrolled Gout
In trial, nearly twice as many hit uric acid targets with allopurinol/lesinurad combination
Number of Children Diagnosed With High Blood Pressure May Rise Under New Guidelines
Simplified tables from American Academy of Pediatrics likely to raise detection rates
Study Finds PCSK9 Inhibitors Are “Still Too Pricey”
Annual list costs need to drop dramatically to meet cost-effectiveness thresholds
Trump Signs FDA Reauthorization Bill, Officially Funding a New Digital Health Unit
New medical device user fee agreement establishes central digital health unit
New Studies of Inflammation in Infarcted Hearts Could Lead to Changes in Therapy
Spanish study overturns dogma that infarction is followed by progressive repair of injured myocardium
Lynparza Receives Additional FDA Approval for Ovarian Cancer
New tablet formulation approved as maintenance treatment regardless of BRCA status
Store-Branded OTC Nexium to Launch by End of September
Perrigo wins FDA approval and settles patient lawsuit with AstraZeneca
FDA Approves Besponsa for Relapsed or Refractory Acute Lymphoblastic Leukemia
Few options have been available for these patients
Mylan Agrees to Pay $465 Million to Resolve EpiPen Medicaid Claims
Company accepts independent annual review of its Medicaid drug rebate practices

P&T August 2017
Table of Contents

Features

FDA Guidance on Biosimilar Interchangeability Elicits Diverse Views
Pharmaceutical industry sectors are at odds as the Food and Drug Administration seeks to define “interchangeability” for biosimilars. The battle lines vary by topic, but biosimilar marketers, health plans, and drugstores are generally urging lower hurdles.
Cancer Immunotherapy, Part 3: Challenges and Future Trends
Despite dramatic breakthroughs, obstacles remain for the field of immunotherapy in cancer. These include the inability to predict treatment efficacy and patient response; the need for improved biomarkers; the development of resistance to immunotherapies; the lack of optimized clinical study designs; and high costs. Are solutions in sight?
Q&A
David B. Nash Advocates Better Outcomes And Lower Costs Through Population Health
As interest grows in the potential impact of population health strategies, a recognized leader in the field—the founding dean of the Jefferson College of Population Health—explains key concepts and the role for this approach in safety, efficacy, and costs.
Development of Antibiotic Stewardship Practices Targeting Urinary Tract Infections in a Hospital With Consultant-Based Infectious Disease Services
Stewardship programs that ensure proper use of antimicrobials translate to improved patient outcomes. The authors describe the development of an antibiotic stewardship program at a facility with consultant-based infectious disease services.
Meeting Highlights
American Society of Clinical Oncology And European League Against Rheumatism 2017
Notable American Society of Clinical Oncology sessions focused on prostate cancer, non–small-cell lung cancer, and hepatocellular carcinoma. Subjects at the European Congress of Rheumatology included rheumatoid arthritis and axial spondyloarthritis.

Departments

Medication Errors
Some IV Medications Are Diluted Unnecessarily in Patient-Care Areas, Creating Undue Risk
Diluting IV drugs in patient-care areas adds undue risk
Prescription:Washington
FDA Delays Drug-Tracking Pilot Programs
FDA delays drug-tracking pilot programs
Drug and Device News August 2017
Approvals, new indications, regulatory activities, and more
Pharmaceutical Approval Update August 2017
Naldemedine (Symproic) for opioid-induced constipation; deutetrabenazine (Austedo) for chorea associated with Huntington’s disease; and infliximab-abda (Renflexis), a Remicade biosimilar, for the treatment of Crohn’s disease, rheumatoid arthritis, and other diseases.
Drug Forecast
Probuphine (Buprenorphine) Subdermal Implants for the Treatment Of Opioid-Dependent Patients
Probuphine (buprenorphine) subdermal implants for the treatment of opioid-dependent patients
Research Briefs August 2017