FDA sued over lethal injection drug import; Teva gets FDA warning;

> The FDA is being sued on behalf of death-row prisoners; lawyers are demanding that a Federal District Court prohibit importation and use of sodium thiopental. Article 

> Teva has received an FDA warning letter following the September inspection of its oral solid dosage manufacturing plant in Jerusalem. Story

> "Questionable" manufacturing and marketing practices have led to the third big financial hit GSK has taken since mid-2010, a fourth-quarter legal charge of $3.5 billion. Article

> Thanks to tip-offs by manufacturers, the FDA was able to avert 38 drug shortages last year by helping to find raw material suppliers, alternative production sites and foreign manufacturers. News

> Improved manufacturing efficiency from its Project Fuel optimization initiatives was more than offset by lower net sales and higher expenses for Hospira, resulting in a 37 percent decline in fourth-quarter profit. Report

> U.K. CMO NextPharma is adding prefilled syringe capabilities at its facility in Belgium. Item

> Lack of senior leadership and poor visibility of the supply chain to execs are the main barriers to strategy implementation. Story

> NextPharma has named Brigitte Genard quality director at its sterile contract development and manufacturing plant in Belgium. NextPharma 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.