Seven firms were selected for a two-phase FDA program linking new US manufacturing facilities to planned NDA/BLA/ANDA filings or supplements, targeting supply needs and unmet medical needs. Phase 1 ...
Only 18% of payers report using RWE in coverage decisions despite 80% expressing demand, reflecting a market access disconnect driven primarily by interpretability and usability barriers. Payers’ ...
This week's Pharma Pulse covers the launch of Medicare's GLP-1 Bridge, FDA's approval of the first regulatory T-cell therapy for chronic GVHD, seven companies tapped for FDA's PreCheck manufacturing ...
Deanna Horner, EVP of Enterprise DIRECT Strategy at EVERSANA, breaks down what's fueling pharma's embrace of direct-to-patient models. The direct-to-patient (DTP) channel has moved from experimental ...
Capital is flowing into CGTs, while outpatient CAR-T delivery reached 45% in 2025, expanding the number of administration sites requiring specialized, time-critical logistics support. Maintaining vein ...
Gerren McHam of the API Innovation Center outlines what a whole-of-government approach to meaningful pharmaceutical supply ...
Gerren McHam of the API Innovation Center on what a resilient US pharmaceutical supply chain looks like in five to ten years, and what execution actually requires. In the final part of his interview ...
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