DSCSA Compliance Guide: What to do now that enforcement as begun

Thani Jambulingam, Ph.D., says MFN pricing, Section 232 tariffs and PBM reform will converge to shape how pharma launches and commercializes new drugs.

In this week’s Pharma Pulse, Lilly brings Zepbound and Foundayo to Hims & Hers, Swisslog Healthcare expands its Tenutō cold storage line, and FDA adds a NAION warning across the GLP-1 class.

In Episode 1, Part 3, Jon Hamrick, Rena Goins and Bob Cochran explain why specialty networks should start small and how to balance access, data and support.

In Episode 1, Part 2, Jon Hamrick, Bob Cochran and Rena Goins explain why trade belongs in commercial planning at least a year before launch.

CVS Health’s proposed separation of its retail pharmacy business from insurance and pharmacy benefit management raises a fundamental question: Will changing ownership improve pharmaceutical distribution, competition and patient access, or simply redistribute market power?

In Episode 1, Part 1, Jon Hamrick, Rena Goins and Bob Cochran discuss how 340B, the IRA, specialty therapies and launch planning have reshaped the role of commercial trade.

APIIC's Brian Doty says renovating shuttered US plants with advanced manufacturing is faster and cheaper than building new to reshore generics.

Joint clinical assessment, shifting HTA demands and pricing pressure are making launch the start of continuous evidence generation.