Genmab — Januar 2021
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this approval was very fast, specially if you consider the pandemic... 'The FDA approved this application 7 weeks ahead of the FDA goal date.' https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-darzalex-faspro-newly-diagnosed-light-chain-amyloidosis
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Ja, der er fart på:
Purpose of the RTOR Pilot
The Oncology Center of Excellence Real-Time Oncology Review (RTOR) pilot program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality and balancing the review team’s workload through data and analysis standardization, and early iterative engagement with the applicant. -
ØU i dag: "Genmab går mod nye højder i det nye år. Der er linet op til et kapløb mellem Genmab og Roche indenfor de bi-specifikke antistof-fer i NHL. Efter lidt konsolidering omkring det nuværende kursleje virker aktien nu klar til at bevæge sig op i nye højder i det nye år". ...
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Nyheden fra i går aftes er i sagens natur ikke med i David Myginds artikel.
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David skriver skriver dog, at de fantastiske ANDROMEDA-data, der blev fremlagt på ASH underbygger ræsonnementet, at lanceringssandsynligheden i AL er 100 procent. Det fik han så ret i.
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Han forventer, at amy-loidosis-salget bliver 200 mio. USD.
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TEPEZZA Short-Term Supply Disruption FAQ https://www.horizontherapeutics.com/media-center/horizon-resources/tepezza-short-term-supply-disruption-faq
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E L. Unfortunately not the first quarter. That is the top sales estimate.
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Dara is fully established, it is not a new drug, most MD’s will already have had experience with it and a lot of them even with SC. You can see from the numerous twitter reactions how enthusiastic most MD’s are. It is the first and only therapy and It will go straight to first line.
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Besides the 4000 new patients expected to get diagnosed this year, there are many currently waiting for new treatment. In addition, amyloidosis is significantly under-diagnosed; I expect that 4000 number to go up over the next few years when MD’s learn what to look for. JNJ already started an awareness campaign.
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