Genmab — September 2015
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Her er FDAs egen glitter brochure for 2014 approvals: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM430299.pdf
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With a move away from general cytotoxic chemotherapy drugs with marginal efficacy findings to targeted drugs having unprecedented response rates, the review question is not whether we should approve the drug, but how quickly we can approve the drug.
These types of applications do not need to go to ODAC.
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Many drugs are vying for expedited approval, and preparations for ODAC would slow down the approval.
“In making a decision regarding whether an ODAC is necessary, we must also balance the timing of the meeting versus an expedited approval,” Pazdur said. “Our office has commonly approved important applications prior to their Prescription Drug User Fee Act goal date.
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God morgen.
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Godmorgen
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"
Spørger man rundt blandt speciallæger på hospitalerne, så betegnes Genmabs Daratumumab som noget nær en gamechanger på niveau med da mobiltelefonen blev introduceret. Her vil man altså ikke tøve med at anbefale, eller gøre brug af produktet" -
Altid godt at starte dagen med et positivt indspark.
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Om ikke andet så har PR givet en masse positiv omtale...mon ikke der er flere der har fået blod på tanden
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