FDA to pursue pharma exec prosecutions; Portal aids cold-chain audits;

> Following GAO criticism of its industry performance-standards development, the FDA says it plans to "thoughtfully" invoke its seldom-used "strict liability" tool to prosecute corporate executives for criminal actions within their companies. Article

> The Kelsius Cold Chain Portal sits atop a SaaS-based wireless sensor network, providing data from various operational points to a repository that can format audit trail documentation. Release

> VGXI has nearly doubled its cGMP plasmid manufacturing facility in Texas to meet demand for our research and manufacturing services. Announcement

> India is claiming title as the world's top exporter of generic medicines. Article

> The FDA has given its thumbs-up to the facility intended for commercial production of Cell Therapeutics' non-Hodgkin's lymphoma treatment pixantrone, expected to undergo FDA review this month. Release


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.