Catalent says FDA made three observations in Eylea inspection, Bloomberg reports

Catalent (CTLT) says its facility underwent inspection related to its role in production of Regeneron’s (REGN) Eylea, that the FDA made three observations in the inspection and that the company has already provided proposed corrective actions, according to Bloomberg. The comments follow yesterday’s news that the FDA issued a Complete Response Letter, or CRL, for the Biologics License Application, or BLA, for aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy, which Regeneron said was “solely due to an ongoing review of inspection findings at a third-party filler.”