Genmab — Juli 2020
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-Yes. So the timing for ofa was based on, as you remember, the 3-month extension from the FDA. And the timelines currently are in the mid-September time frame. I don't have the exact date, but it's mid-September. And so we're negotiating the aspects of label with FDA. And we expect to reach those timelines, as Vas presented earlier.
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So we really feel that there's no better time to bring a highly efficacious and safe treatment that can be administered at home to MS patients considering the context. Our initial focus will be to really drive the broad adoption with MS specialists and general neurologists. And we're using a really highly agile approach between face-to-face and virtual outreach. We've actually developed a digital affinity score for physicians to understand where they are and how much digital promotion we can do.
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We're also leveraging our learnings from recent launches and facing significant focus on patient services to ensure seamless and flexible onboarding. So that's really -- our objective is to make sure that patients can access quickly and easily ofatumumab. We expect to see ramp-up in 2021 as we see the conversion of patients to product in ex U.S. towards the second half of 2021.
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A- Yes. So on Arzerra, I think the black box warning specifically refers to both PML cases and HBV reactivation. And looking at the mechanism of ofatumumab, if you think about the overall approach, what we've actually looked at for ofatumumab is the fastest B cell repletion. So when patients are actually receiving subcu injections,
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they have very low and very quick recovery of their B cells. So in return, in the studies for ASCLEPIOS I and II, we did not see any cases of PML and we also did not see any cases of HBV reactivation. So you can -- I think the FDA will accurately reflect what was in our ASCLEPIOS I and II studies. And I believe that will be the readthrough in terms of how we will have the label moving forward.
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Kiadis announces publication in Blood highlighting proof-of-concept to enhance potency of anti-CD38 antibodies with Kiadis’ K-NK004, recently licensed by Sanofi https://www.globenewswire.com/news-release/2020/07/22/2065517/0/en/Kiadis-announces-publication-in-Blood-highlighting-proof-of-concept-to-enhance-potency-of-anti-CD38-antibodies-with-Kiadis-K-NK004-recently-licensed-by-Sanofi.html
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Thanks for All the info E L
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Ditto from me.
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New Teprotumumab trial - A Randomized, Double-Blind Multicenter Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) - https://clinicaltrials.gov/ct2/show/NCT04478994?term=genmab+OR+daratumumab+OR+darzalex+OR+ofatumumab+OR+Teprotumumab+OR+Tisotumab+OR+camidanlumab+OR+Enapotamab+OR+ADCT-301+OR+duobody&lupd_s=07%2F20%2F2020&draw=2&rank=12
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US Darzalex salg fra Symphony Health for juni USD 219.8M. Juni 22 arbejsdage, mod 20 i maj. Stigning på dagsbasis ca. 8%
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De tidlige nedlukninger i Q2 i Europa må have påvirket ROW kraftigt i negativ retning.
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