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BioWorld - Friday, September 22, 2023

CHMP

Home » Topics » Regulatory » CHMP
  • 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.
  • 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.
  • Ema icons
    July 21, 2023
    By Lee Landenberger

    CHMP says no to Mirati’s lung cancer treatment

    Mirati Therapeutics Inc.’s cancer treatment Krazati (adagrasib) is having a tough time outside the U.S. The EMA’s Committee for Medicinal Products for Human Use (CHMP) came out with a negative opinion on an MAA for treating KRAS G12C-mutated advanced non-small-cell lung cancer (NSCLC). The ruling came with a flurry of positive CHMP opinions for companies, including Abbvie Inc., Beigene Ltd. and the Janssen Pharmaceutical Cos., plus a mixed result for Ipsen SA after a stumble earlier this week.
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  • Randy Osborne
  • Cormac Sheridan
  • Michael Fitzhugh
  • Lee Landenberger
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