FDA offers bioequivalance API guidance; U.S. gets BASF's API HQ; Daiichi Sankyo consolidates;

> The FDA has issued draft guidelines for dozen of APIs intended to provide insight for drugmakers designing bioequivalance studies. Guidelines

> BASF ($BASF) will move the world headquarters for its API and excipient operations, Pharma Ingredients & Services, to Florham Park, NJ, from Switzerland. Item

> Japanese drugmaker Daiichi Sankyo is consolidating two plants and its logistics operations to make them more efficient. Item

> Indian drugmaker Anil Bioplus says it will spend about $28 million to build a plant in Halol, India, where it will manufacture enzymes and bio-chemical products. Report

> Lonza will manufacture Mydicar, an enzyme replacement therapy, for trials for developer Celladon, with the potential for a supply agreement if the treatment is approved. Item

And Finally... Indian manufacturer Dishman Pharmaceuticals and Chemicals says it intends to launch 60 generic APIs over the next 24 months. Story


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.