January/February 2016

Complera treats HIV infection in previously untreated adults with a viral load of 100,000 copies/mL or less.

The second article in a two-part series examines oncology drug approvals and late-breaking FDA actions.

Specialty pharmacies could serve as the primary conduit to generate value from at-risk agreements between manufacturers and providers.

USP may subject pharmacies to both state board and FDA inspections.

The global launch of a new drug requires careful orchestration of sales and marketing support activities—a challenge that can have a large financial impact.

Industry stakeholders must carefully examine every detail of drug adherence programs to ensure compliance with the Anti-Kickback Statute.

Unique compliance issues may affect specialty pharmacy distribution plans.

Approvals expected for new drugs to treat bladder cancer and advanced ER+ breast can­cer.

Pharmacists must understand the potential value of biosimilars as a competitive generation of more cost efficient drugs hit the market.

OptiMed takes a value-driven approach to specialty patient management.

CRISPR technology may eventually hit the specialty landscape with promising treatments for HIV and cancer.

Lines must be drawn among specialty pharmacies and manufacturers to ensure professional services do not exceed regulatory parameters.