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Tuesday, September 11, 2018

FDA review of Akorn facility finds data integrity issues, Bloomberg reports


A six-week review by the FDA of Akorn’s (AKRX) Somerset, New Jersey, facility found some of the same data integrity issues that were cited by Fresenius SE (FSNUY) in its cancellation of the $4.3B buyout of the generic drugmaker, Bloomberg reports, citing an unsealed court filing. Delaware Chancery Court JudgeTravis Lasteris scheduled hold a telephonic hearing today on Akorn’s request to provide details on the FDA review before the judge issues a ruling in the case, Bloomberg adds.

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