The U.S. FDA issued a handful of warning letters to device makers in the month of April 2024, one of which is for the Waukegan, Il., plant operated by Cardinal Health Inc., of Dublin, Ohio. While the Waukegan plant escaped citations for most routine Quality System Regulation deviations, the FDA said Cardinal’s handling of contract manufactured luer locks and syringes fell well short of the agency’s expectations given that these issues led to a massive recall, a product removal and an FDA advisory.
The U.S. FDA announced March 7 that Cardinal Health of Dublin, Ohio, has expanded a product correction for Monoject devices to a product removal because of manufacturing changes that could affect product performance.
A slew of biosimilar versions of TNF-alpha inhibitor adalimumab will finally arrive on the U.S. market in 2023, almost seven years after the first such molecule, Amgen Inc.’s Amjevita (adalimumab-atto) gained U.S. FDA approval. Amgen commercially launched its product on Jan. 31. Seven more are lined up for launch over the summer, while two more are undergoing regulatory review. Their long-anticipated arrival will mark the beginning of the end for one of the most lucrative franchises in the history of the pharmaceutical industry. It represents, according to Cardinal Health Inc.’s newly published 2023 Biosimilars Report, “the largest loss of exclusivity event, perhaps ever in the U.S.”
A proposed $26 billion global settlement could end the state-by-state opioid litigation in the U.S. for Johnson & Johnson (J&J) and three drug distributors. The attorneys general from several states announced the proposed agreement July 21 with J&J, Amerisource Bergen Drug Corp., Cardinal Health Inc. and McKesson Corp.
Three of the largest biopharma distributors in the U.S. agreed to a settlement of $1.179 billion with New York, bowing out of the state’s ongoing opioid lawsuit.
Less than six years after acquiring Cordis Corp. from Johnson & Johnson, Cardinal Health Inc. is selling the troubled cardiovascular device manufacturer to private equity firm Hellman & Friedman LLC for roughly $1 billion. Shares of the medical products and drugs distributor (NYSE:CAH) were up 2.93% to $57.35 at close on Friday.