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Real-world Evidence (RWE) for Regulatory and Reimbursement Decisions

We have previously discussed the potential roles of real-world data (RWD) and real-world evidence (RWE) for drug access. However, the precise roles of RWE...

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for...

KENILWORTH, N.J.--(BUSINESS WIRE)--FDA Grants Priority Review to Merck’s Supplemental BLA for KEYTRUDA® (pembrolizumab) with Inlyta® (axitinib) as First Line Treatment for Advanced RCC

U.S. proposes Medicare coverage for CAR-T cancer therapies

The U.S. Centers for Medicare & Medicaid Services (CMS) on Friday proposed Medicare coverage of approved CAR-T cell therapies that use the patient's immune system to fight cancer.

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Trends in The New Value-Based Reimbursement Model

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