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 ...
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 ...
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 ...
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