Genmab — November 2022
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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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BioNTech Announces Third Quarter 2022 Financial Results and Corporate Update https://investors.biontech.de/news-releases/news-release-details/biontech-announces-third-quarter-2022-financial-results-and - Presentation - https://investors.biontech.de/static-files/49e8b81b-bc33-4d65-85ea-c935610dd6b2
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Genmab sammen med Bava, har ingen omsætning i dag, så det er nok Hr. og Fru. Jensen der styrer markedet med de små handler.
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Esmo abstract Dec 1. At 00.05 https://www.esmo.org/meeting-calendar/esmo-immuno-oncology-congress-2022/abstract
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