Genmab — November 2018
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Amgen fik Kyprolis godkendt 4 mdr efter data release på ny dosering weekly i stedet for to https://www.amgen.com/media/news-releases/2018/10/fda-approves-kyprolis-carfilzomib-onceweekly-70-mgm2-in-combination-with-dexamethasone-kd70-for-patients-with-relapsed-or-refractory-multiple-myeloma/
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Men der var jo ikke tale om en ny opskrift. Det er der med dara sc + rhuph20. Supplements with CMC formulation changes and supplements with pharmacology/toxicology data will be excluded. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm
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Nu kender de jo begge stoffer ganske godt. Men det er da muligt du har ret. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf
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