Archive for June 2019

How real world evidence was used to support approval of Ibrance for male breast cancer “Leveraging RWD to improve regulatory decisions is a key strategic priority for the FDA. This data may be derived from a variety of sources, such as electronic health records, medical claims, product and disease registries, laboratory test results and even…

 “Immune Checkpoint Inhibitors (ICIs) were first approved for the treatment of aNSCLC in 2014, and since this time have seen rapid adoption in the marketplace. [This study] sought to describe the characteristics of patients with aNSCLC receiving ICIs in the real-world, as well as to examine treatment patterns and outcomes in the time since initial…

  “Data collection infrastructure for patient outcomes in the UK – opportunities and challenges for cell and gene therapies launching” “Existing data collection infrastructure in indications with potential cell or gene therapies launches in the next five years in the UK is overall not sufficient to facilitate outcomes-based reimbursement.” Click here to see the source article  Reference Jørgensen, J.,…