FDA suggests 2-mm beads to thwart chewers; DDN commits to the cold;

> Unintentional bead chewing may affect pharmacokinetics, so FDA suggests a maximum of two-millimeter beads in modified-release treatments formulated for sprinkle delivery. Draft guidance

> Channel management specialist DDN has added 140,000 square feet of temperature-controlled space, bringing its total Memphis footprint to one-half million. DDN release

> Morphotek is half way to completing its 60,000-square-foot pilot manufacturing plant for trial drugs; October is the targeted finish date. Article

> Belgian Manuel Calvelo has pleaded guilty in U.S. district court in Kansas to running an Internet pharmacy that sold $1.4 million worth of misbranded and counterfeit drugs. Article

> International law firm King & Spalding announces that former FDA official Steven Niedelman has joined the company's Washington, D.C., office as lead quality systems and compliance consultant. King & Spalding 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.