Genmab — November 2022
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Der er ingen fast tidsgrænse for hvornår fda skal meddele acceptance. Gilead fik f.eks. I sommers acceptance efter en måned. https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-fda-acceptance-of-new-drug-application-for-investigational-lenacapavir
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The timelines for NMEs and BLAs that fall under PDUFA V’s “Program”
Review Model are 10-months for standard applications and 6-months for priority reviews from the 60-day filing date (or 12 months
and 8 months respectively from the date of submission of the application). -
Alle detaljer findes her: https://www.fda.gov/media/78941/download
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Det har også undret mig at de får Milestone ved acceptance. Men Andrew Carlsen bekræftede jo ved sidste q&a, at det gør de. Om de så får igen ved godkendelse må tiden vise. Hvad angår størrelsen, skrev de forleden i meddelelsen, at den var signifikant. Det er hvad vi ved - så vidt jeg ved.
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GSK’s Blenrep fejlede endemål i MM. https://www.reuters.com/business/healthcare-pharmaceuticals/gsks-blood-cancer-drug-fails-main-goal-superiority-trial-2022-11-07/
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small mention of epcoritamab in the EMEA CHMP agenda for this week, under B.6.1. Start of procedure for New Applications: https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-7-10-november-2022_en.pdf
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