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Clinical Trials
0
0 active
Approvals
5
Total approvals
Agencies
2
Regulatory bodies
Founded
N/A
No trial phase data available
No trial data available
FDA
Food and Drug Administration
CANADA
Health Canada
3
- The Health Resources and Services Administration has approved eight pharmaceutical companies to participate in the 340B Rebate Model Pilot Program, which will begin on January 1, 2025. - Nine drugs from major manufacturers including Bristol Myers Squibb's Eliquis, Novo Nordisk's Novolog, and Janssen's Stelara will be included in the voluntary rebate program. - The pilot program allows drugmakers to provide 340B discounted pricing through a rebate model rather than upfront discounts, with HRSA planning to evaluate the program for at least one year. - The initiative follows legal challenges from Johnson & Johnson, Bristol Myers Squibb, and Eli Lilly regarding HRSA's authority to review and approve rebate models in the 340B program.
