Genmab — April 2016
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Tak Bulder. Det vil jeg glæde mig til
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den har ikke opdateret i lang tid
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Fra blogbuster: The CHMP met today and has given Darzalex the green light: Dara wins EMA backing for approval. It shouldn’t be long now before official EMA registration. A great way to close an awesome week… Today, the Committee has issued a positive opinion recommending the grant of a conditional marketing authorisation for Darzalex in the EU for treatment of relapsed and refractory multiple myeloma. Darzalex has an orphan designation and was reviewed under EMA’s accelerated assessment scheme.
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On September 9, Janssen filed with the EMA and today, 205 days later, the positive opinion was issued. That’s close to their 210 day regular schedule, however, with its very rare ‘accelerated assessment‘ the EMA skips the 3-months clock stop. As such, this opinion has come 3 months and 5 days faster.
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