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BioWorld - Thursday, September 28, 2023

EMA

Home » Topics » Regulatory » EMA
  • Boy in wheelchair
    Sep. 15, 2023
    By Randy Osborne

    Repeat defender: PTC to appeal Translarna case in Europe – again

    “We’re going to battle,” PTC Therapeutics Inc. CEO Matthew Klein said, responding to a surprise negative opinion from the EMA’s Committee for Medicinal Products for Human Use on converting the conditional marketing authorization to full status for Translarna (ataluren) in the treatment of nonsense mutation Duchenne muscular dystrophy. The opinion applies to the renewal of the existing conditional authorization, too.
  • Ema icons
    Sep. 14, 2023
    By Mari Serebrov

    One trial, two regulators, two opinions on Oncopeptides drug

    Supporting their conclusions with data from the same phase III study, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for extending the use of Oncopeptides AB’s Pepaxti (melflufen) to earlier lines of treating relapsed, refractory multiple myeloma even as the FDA dug in its heels about withdrawing the drug from the U.S. market.
  • Sep. 6, 2023
    By Mari Serebrov

    Time for US biosimilar path to catch up with the science?

    Now that the U.S. FDA has nearly 15 years of experience with developing and implementing a biosimilar pathway, it’s time for that regulatory path to catch up with the science, according to experts that have been involved in biosimilar development even before Congress passed the Biologics Price Competition and Innovation Act that created the framework for the U.S. biosimilar market.
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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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  • Lynn Yoffee
  • Nuala Moran
  • Cormac Sheridan
  • Marie Powers
  • Randy Osborne
  • Mari Serebrov
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