FDA warning letters to foreign manufacturers jump 40%; Novartis turns to CMO to meet demands;

> The FDA sent 52 GMP warning letters in the last 12 months, and 40% of those were to manufacturing plants outside the U.S. Story

> Novartis ($NVS) is using some contract manufacturing operations to help it meet drug demands while its plant in Nebraska continues remediation. Story

> The FDA has sent letters to more than four dozen doctors and medical practices in the U.S. warning them they may have purchased counterfeit Avastin, which, if used, could harm patients. Story

> Spectrum Pharmaceuticals ($SPPI) says it has increased its manufacturing capacity for cancer treatment Fusilev (levoleucovorin) for injection. Item

> Novasep, which makes pharma purification systems, has named Jean-Claude Romain director of quality and placed him on the company's executive committee. 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.