Cardinal HealthNYSE: CAH

Cardinal Health (CAH) recalls its procedure kits that contain plastic syringes manufactured by a Chinese manufacturer, Jiangsu Shenli.

PDUFA Target Action Dates in Late December 2024 Highly Selective CRF1 Antagonist is the Potential First New Treatment for CAH in 70 Years SAN DIEGO , July 1, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has accepted its two New Drug Applications (NDA) with Priority Review designations for crinecerfont in the treatment of children, adolescents and adults with classic congenital adrenal hyperplasia (CAH). If approved, crinecerfont would be the first new treatment option for CAH in 70 years and a first-in-class therapy, with a novel approach for the treatment of this rare and serious endocrine disorder.

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SAN DIEGO , June 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) and Diurnal Ltd., a Neurocrine Biosciences company, presented information from its neuroendocrinology pipeline at the Endocrine Society Annual Meeting, ENDO 2024, including primary data just published in The New England Journal of Medicine from its CAHtalyst™ Phase 3 registrational studies of crinecerfont in pediatric and adult patients with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency.

-          CAHtalyst™ Pediatric Study Met Primary and Key Secondary Endpoints, with Crinecerfont Treatment Decreasing Androstenedione Levels and Enabling Glucocorticoid Dose Reduction While Maintaining Androstenedione Control     -          30% of Crinecerfont Participants Achieved a Physiologic Glucocorticoid Dose at Week 28 while Maintaining Androgen Control versus 0% of Placebo Participants     -          Favorable Trends in Endpoints Reflecting Supraphysiologic Glucocorticoid Dosing and Androgen Excess     -          Crinecerfont was Generally Well Tolerated SAN DIEGO , June 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the primary study results from its CAHtalyst™ Pediatric Phase 3 study investigating crinecerfont for the treatment of congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency have been published in The New England Journal of Medicine online edition and will appear in a future print issue of the journal. The CAHtalyst Pediatric Phase 3 study met the primary and key secondary endpoints related to androgen reduction (during an initial glucocorticoid-stable period) and glucocorticoid (GC) dose reduction while maintaining androgen control.

100% of Participants (n=6) With CAH Maintained Androstenedione (A4) Below the Upper Limit of Normal at all Time Points on Atumelnant (80 mg)

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Cardinal Health (CAH) gains from a solid pharmaceutical segment and a diversified product portfolio. Gross margins improve.