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BioWorld - Monday, June 29, 2026

U.S.

Home » Topics » North America » U.S.
  • Performance hit target
    June 29, 2026
    By Marian (YoonJee) Chu

    Samsung Bioepis’ Keytruda biosimilar hits phase I, III endpoints

    Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement.
  • Us law flag gavel
    June 29, 2026
    By Mari Serebrov

    The court said what it said, DC Circuit tells Norwich

    While the U.S. Supreme Court made it clear earlier this month in Hikma v. Amarin that skinny labels are still on the board for generics, the court didn’t resolve all disagreements over the generic carveouts.
  • Acquisition puzzle
    June 29, 2026
    By Jennifer Boggs

    Zymeworks bolsters royalty stream with Theravance buy

    One company was looking to add to its royalty stream and R&D portfolio. The other was seeking strategic alternatives in the wake of clinical misfires over the last few years. In an agreement aimed at satisfying both goals, Zymeworks Inc. will acquire Theravance Biopharma Inc., paying $17 per share, or about $929 million, though the transaction is structured in a way that minimizes the former’s current capital position.
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  • Health care politics illustration
    Aug. 26, 2020
    By Mari Serebrov

    U.S. politicking threatens public trust in the FDA and CDC

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