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BioWorld - Sunday, January 11, 2026

EMA

Home » Topics » Regulatory » EMA
  • Inspection illustration
    Jan. 5, 2026
    By Nuala Moran

    EMA gets to work on implementing new EU pharmaceutical rules

    After welcoming the political agreement on the EU pharmaceutical legislation in December 2025, the EMA says it will be devoting 2026 to “intense preparation” for its implementation.
  • Lung cancer 3d illo
    Dec. 23, 2025
    By Lee Landenberger

    Patient deaths prompt halt in Merck-Daiichi phase III in lung cancer

    Daiichi Sankyo Inc. told BioWorld it voluntarily placed a partial hold in recruitment and enrollment in the phase III IDeate-Lung02 study of antibody-drug conjugate ifinatamab deruxtecan because of a higher than anticipated incidence of grade 5 interstitial lung disease events. The company did not say how many deaths there had been.
  • Lung cancer 3d illo
    Dec. 19, 2025
    By Lee Landenberger

    Patient deaths prompt halt in Merck-Daiichi phase III in lung cancer

    Daiichi Sankyo Inc. told BioWorld it voluntarily placed a partial hold in recruitment and enrollment in the phase III IDeate-Lung02 study of antibody-drug conjugate ifinatamab deruxtecan because of a higher than anticipated incidence of grade 5 interstitial lung disease events. The company did not say how many deaths there had been.
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Blog Posts

  • Oct. 28, 2013
    By Marie Powers

    Patient Experience Still Undervalued in Regulating Drugs

  • July 10, 2012
    By Cormac Sheridan

    Venter, Watson Warm Up for Clash of the Titans

  • May 7, 2012
    By Nuala Moran

    The EMA’s Shambolic Handling of Glybera

  • June 27, 2011
    By Lynn Yoffee

    Video Coverage from #BIO2011 - State of the British Biotech Industry

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