FDA sends Bausch & Lomb warning letter; Lonza picked to manufacture stems cells;

> Bausch & Lomb has received a warning letter from the FDA saying that 6 dilutions of pilocarpine hydrochloride ophthalmic solutions should be treated as prescription drugs. Letter

> The European Medicines Agency (EMA) has issued new guidance to drug manufacturers of slow release oral and patch products on what it expects them to do to show that "the prolonged release product maintains its drug release characteristics regardless of relevant variability in physiological conditions." Story

> Lonza has received a $9.5 million grant from the National Institutes of Health to provide GMP manufacturing of induced pluripotent stem cells (iPSCs) and clinical-grade iPSC-derived cell types. Item

> Hungarian drug developer Genetic Immunity has gotten approval from regulators there for a manufacturing facility in Budapest for clinical trials material and eventually for commercial production. Release

And Finally... A joint event between CPhI and a Russian pharma group will be held in April in St. Petersburg, Russia. Item


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.