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Latest From bluebird bio

Sen. Cassidy Gives Strong Defense – And Asks Tough Questions – Of Pharma CEOs At Hearing

Despite objecting to Democrats’ reasons for hauling three pharma CEOs in front of the Senate Health Committee, Ranking Member Bill Cassidy pressed the execs on anticompetitive tactics on biosimilars and how to keep gene therapies from bankrupting state Medicaid programs.

Legislation Market Access

Gene Therapy: US FDA Willing To Accept Single-Arm Trials For Approval, But Sponsors May Hesitate

Data indicates a smaller percentage of studies intended for product registration or indication expansion are single-arm trials, compared to the proportion for all gene therapy trials.

Gene Therapy Clinical Trials

Medicaid Payments For Cell, Gene Therapies Outside Hospital Bundle Supported By Developers

Separate, and higher, payments outside the bundle means manufacturers will owe Medicaid rebates, and that is OK, Alliance for Regenerative Medicine tells Sen. Cassidy. But manufacturers want assurances they won't be liable for rebates on treatments included in bundled payments.

Reimbursement Gene Therapy

Sickle Cell Gene Therapy In Medicaid: CMMI Model As ‘Bandwidth Extender’ For Less Resourced States

Outcomes-based contract that federal government will negotiate with manufacturers on behalf of Medicaid programs might not be appealing to large states. Bluebird and Vertex can apply to the demonstration project this spring and negotiations would follow between May and November.

Reimbursement Policy
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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
      • Macromolecule
  • Biotechnology
    • Gene Therapy, Cell Therapy
    • Large Molecule
  • Other Names / Subsidiaries
    • Genetix Pharmaceuticals
    • Precision Genome Engineering, Inc. (Pregenen)
    • Oncology Newco