India releases biosimilar manufacturing guide; Frazier wraps up packaging deal;

> India used the BIO 2012 conference to release new "similar biologics" guidelines that will require manufacturers of biosimilars prove similarity within four years of post-market safety data to either a drug licensed in India or one approved elsewhere. Story

> Catalent Pharma Solutions is partnering with formulation specialists Bend Research to offer integrated solutions for the development and manufacture of specialized multiparticulate oral controlled-release products. News

> Pluristem Therapeutics, a developer of placenta-based stem-cell therapies, is building a manufacturing facility near its headquarters in Haifa, Israel, even before it has gotten its therapy approved. Story

> Food Standards Australia New Zealand is alerting the public against taking sports food supplements containing 1,3-dimethylamylamine (DMAA) because of its links to high blood pressure and other adverse health effects. Item

> Frazier Healthcare has completed its acquisition of Catalent Pharma Solutions' U.S. commercial pharmaceutical packaging operations and will run as Packaging Coordinators, Inc., which is what it was previously named. Report

> Healthpoint Biotherapeutics says it will invest about $60 million to add 25,000 square feet of manufacturing infrastructure, as well as lab and clean room space in Fort Worth, TX, for production of its cell-based products. Announcement


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.