FDA and EMA get comfortable in joint inspections; GSK, Pfizer provide discounted vax to GAVI;

> The FDA and the European Medicines Agency continue to cozy up, moving from confidence-building in their joint GMP inspections to reliance upon each other. Story

> GlaxoSmithKline ($GSK) and Pfizer ($PFE) say they will provide 180 million doses of discounted pneumococcal vaccine for use by the Global Alliance for Vaccines and Immunization. Story

> Covidien ($COV) says it plans to spin off its $2 billion pharmaceuticals business, creating a public company. Article

> DSM Sinochem Pharmaceuticals will build a production facility for semi-synthetic cephalosporins in Zibo, China. Story

> Pfizer ($PFE) has put three real estate lots--the last of its presence in Brooklyn--on the market. Item

> Contract service provider Advanced BioScience Labs has hired industry vet Claire Zhang to lead its downstream bioprocessing group. Item

> Lonza has expanded its early-phase, small-molecule manufacturing capacity in Nansha, China. Announcement

> Tom Flachmeyer has joined Prolong Pharmaceuticals to head the engineering and facilities planning function for it oxygen therapeutic product, Sanguinate. 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.