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P&T August 2017


Current and Potential Marketers Complain About Too-High Hurdles

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.

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?


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.

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

Notable American Society of Clinical Oncology sessions focused on prostate cancer, non–small-cell lung cancer, and hepatocellular carcinoma.

Meeting Highlights

Subjects at the European Congress of Rheumatology included rheumatoid arthritis and axial spondyloarthritis.


Medication Errors

Diluting IV drugs in patient-care areas adds undue risk


FDA delays drug-tracking pilot programs

Approvals, new indications, regulatory activities, and more

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