BREAKING NEWS

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
Novo Nordisk's Semaglutide Bests Trulicity in Diabetes Trial
Longer-acting GLP-1 diabetes drug reports strong results in Sustain-7 trial
Dramatic Increase in Knee Osteoarthritis Likely Related to Modern Environment
Damage to the joint may be “partly preventable,” researchers say
FDA Puts New Restrictions on Hiring of Foreign Scientists, Documents Show
Policy linked to newly updated requirements for government employee ID cards
Biogen, Merck Use Predictive Modeling to Better Negotiate Value-Based Contracts
Drug-makers utilizing this strategy to better understand the value of their products
Study: Doctors Trained at Lowest-Ranked Medical Schools Prescribe More Opioids
Analysis finds that the prescribing disparity is greatest among general practitioners
Gene-Editing Pioneers to Receive $500K Prize for the Development of CRISPR-Cas9
Scientists’ contributions “revolutionized biomedical research”
South Carolina Sues OxyContin Maker Purdue Over Opioid Marketing
Such suits are seeking to holding pharma partially accountable for the opioid epidemic
Multiple Products From Florida Company Recalled Due to Bacteria Concerns
Products manufactured by PharmaTech were sold by three firms

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 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
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