REMS for new biologic; CMO pair seeks high-volume orders;

> The FDA has required a risk evaluation and mitigation strategy for Xiaflex, the recently approved biologic from Auxilium Pharmaceuticals. Item

> A collaboration between Albemarle Corp. and PharmaCore aims to handle projects that require high-volume capacity. Release

> East African nations are considering counterfeit-drug legislation that threatens generics--to India's dismay. Article

> Formatech is celebrating the issuance of U.S. patent 7,659,310, "Methods of Enhancing Solubility of Agents," which covers novel formulation methods for hydrophobic compounds. Release

> The $20-million Abacus Parenteral Drug facility in Mukono, Uganda, is up and running, yielding cheaper drugs and displacing imports from Europe and India. Article


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

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

Learn how 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.