FDA Voucher Leads to Speedy Approval of Boehringer Drug for First-Line Use in Lung Cancer

The label expansion for Boehringer Ingelheim’s Hernexeos was made under an FDA pilot program that accelerates regulatory review of products with national interest. The daily pill is now approved as a first-line treatment for HER2-positive non-small lung cancer, an indication with few treatment options. The post FDA Voucher Leads to Speedy Approval of Boehringer Drug…

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How do CMS negotiated prices compare to value?

That is the question asked in a recent Health Affairs Forefront article by Peter Neumann, Josh Cohen, Sean Sullivan and Feng Xie. They compare the CMS negotiated prices for Initial Price Applicability Year (IPAY) 2027 against value-based prices (using QALYs) from the Tufts Cost-Effectiveness Analysis (CEA) Registry. The authors found that cost-effectiveness estimates varied among…

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Redefining Clinical Oncology Trials: How Agile Site Networks Accelerate Novel Cancer Therapies

Site networks can play a pivotal role in aligning sponsors, sites, and investigators toward shared goals in oncology clinical trials, but they are not one-size-fits-all. Sponsors must carefully vet site networks to validate that they will deliver strategic value for each individual study.    The post Redefining Clinical Oncology Trials: How Agile Site Networks Accelerate Novel Cancer…

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