KV's Makena rollercoaster descends with FDA compounding OK; J&J tallies another recall, expansion;

> For now, compounding pharmacies will face no regulatory action for producing cheap versions of KV Pharma's just-approved and high-priced pre-term birth drug, Makena. Story

> Add a one-lot recall of Tylenol 8-Hour caplets to J&J/McNeil's ongoing callback parade; add 718,000 caplets of five other drugs to a previous recall. Story

> The FDA has issued an advisory to drugmakers on the formation of glass Lamellae in Injectables. Advisory

> CMO Almac has invested in two ZED automated inline wallet presses, for plants in Pennsylvania and Craigvon, to speed blister card packing. Story

> Unilife has begun initial production of the Unifill ready-to-fill (prefilled) syringe at its plant in York, PA. Release

> Contract manufacturer Pharma Tech Industries has completed a cleanroom for pouch filling of powder-based products, built to house an Oystar Jones Adjustable Pouch King high-speed unit for packaging and sealing technology. Story

> Contractor AAIPharma has relocated its compendial raw materials testing group to a purpose-built lab at company headquarters in Wilmington, NC, headquarters facility. Release

> Unilife Corp. has begun initial production of the Unifill ready-to-fill syringe at its York, PA, facility. 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.