FDA Actions in Brief November 2012

During the Health System Executive Summit, Candy Tsourounis, PharmD, and Elise Wozniak, PharmD got candid about the barriers and financial risk surrounding this innovative therapy.

Foundational Pharmacy Strategies’ Christine Johnston on how rebate structures, pending legislation, and a stalled pipeline are reshaping — and threatening — the biosimilar market heading into 2027.

Melody Chang, R.Ph., says payers cover bispecific and CAR-T drugs but not the monitoring that lets community practices deliver them safely at lower cost.

Continuous glucose monitoring cut mean A1C from 8.8% to 7.2% over 26 weeks in adults with type 2 diabetes not on insulin, 0.9 points more than routine care in the CONNECT trial.

American Oncology Network’s Melody Chang, R.Ph., says 18% of its first 70 outpatient bispecific patients had CRS, all low grade with no hospitalizations.

A screening program in eight countries found early-stage type 1 diabetes in about 1 in 350 children with no family history of the disease.

Healthcare leaders should be preparing now for important changes in prior authorization and other areas of healthcare.

UC Davis Health’s Tiffany Phung, Pharm.D., and Tim Cutler, Pharm.D., say staff-driven ideas protect research independence in industry partnerships.