Genmab

	22/7 21:17 af E L	this is that article in pdf form in the AJMC journal (link)
	22/7 21:15 af E L	Janssen's Wildgust Breaks Down Bispecific Antibodies in Development for Non-Small Cell Lung Cancer and Multiple Myeloma (link)
	22/7 21:15 af E L	this is a very interesting read:
	22/7 18:00 af E L	this was in the Lancet on that recently Fewer cancer diagnoses during the COVID-19 epidemic in the Netherlands (link)
	22/7 17:14 af Helge Larsen/PI-redaktør	Netop.
	22/7 17:14 af gdn55	Hvordan tror du det gik med kræftbehandlingen i Italien, da hele sygehusvæsnet var ved at bryde sammen.
	22/7 17:14 af Helge Larsen/PI-redaktør	Jeg tænker på hele Europa i relation til ROW.
	22/7 17:06 af AaBforever	Det er rigtigt Helge. Det er altid naboen det går ud over...lige indtil man selv står midt i det.
	22/7 16:57 af Helge Larsen/PI-redaktør	Aabforever...Det har der været skrevet en del i medierne under nedlukningen.
	22/7 16:39 af AaBforever	Ved hvor vigtigt det er at behandling for cancer kører fuldstændig straight, hvis man skal overleve!
	22/7 16:37 af AaBforever	Usmageligt! Hvis man vælger kræftsyge patienter fra!
	22/7 16:28 af gdn55	Ja
	22/7 16:17 af AaBforever	Du mener at de bare får lov til at sejle deres egen sø?
	22/7 15:59 af E L	Senior Vice President (link)
	22/7 15:57 af E L	As we continue our journey toward becoming a fully integrated biotech company, we welcome Brad Bailey as Genmab’s first US General Manager. Brad will lead the Genmab US market organization and build the US team to enable Commercialization success. #Genmabnews
	22/7 15:49 af gdn55	Hvis der under en krise ikke er personale nok til at udfører behandlingerne, må der jo vælges. Hvad der udsættes kan bliver udsat.
	22/7 15:44 af AaBforever	Patienter med cancer får vel ikke mindre behov for medicin og behandling, selv under en coronakrise?
	22/7 15:31 af nohope	Yep. Det kan også sagtens tænkes at der er en mindre effektueringsprocent af Symphony tallene end ellers pga corona.
	22/7 15:06 af Helge Larsen/PI-redaktør	De tidlige nedlukninger i Q2 i Europa må have påvirket ROW kraftigt i negativ retning.
	22/7 13:26 af bikube	Der var det jo en reduktion på prisen, der fik et negativt udslag. Det skulle jo nødigt gentage sig. Jeg blev da noget skuffet over, at ROW blev sat tilbage ift. U S salg.
	22/7 13:17 af nohope	"Problemet" er nok ROW.
	22/7 13:11 af bikube	Hvis man kan holde den stigningstakt, ser det da smukt ud.
	22/7 11:14 af Helge Larsen/PI-redaktør	US Darzalex salg fra Symphony Health for juni USD 219.8M. Juni 22 arbejsdage, mod 20 i maj. Stigning på dagsbasis ca. 8%
	22/7 10:44 af E L	New Teprotumumab trial - A Randomized, Double-Blind Multicenter Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) - (link)

	22/7 10:09 af gentogen	Thanks EL
	22/7 09:57 af E L	i had no choice GB, I was forced ;-)
	22/7 09:54 af Helge Larsen/PI-redaktør	Ditto from me. :-)
	22/7 09:54 af GeorgeBest	Thanks for All the info E L :-)
	22/7 09:49 af E L	we saw this article before, and the funny thing is that it is using Dara instead of Isa ;-)
	22/7 09:48 af E L	Kiadis announces publication in Blood highlighting proof-of-concept to enhance potency of anti-CD38 antibodies with Kiadis’ K-NK004, recently licensed by Sanofi (link)
	22/7 09:30 af E L	So- a lot of attention in that call on Ofa.
	22/7 09:30 af E L	And we expect to get a new trade name, which will actually reflect both the efficacy and safety of the label. So we will get a new brand name associated with this. So I think this would be a different overall label and brand name for ofatumumab.
	22/7 09:29 af E L	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.
	22/7 09:29 af E L	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,
	22/7 09:29 af E L	Q- Vas, you mentioned that you were in final labeling discussions with FDA on ofatumumab. Given it was filed as an sBLA and Arzerra has a black box warning, should we be expecting a black box warning for ofa?
	22/7 09:28 af E L	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.
	22/7 09:28 af E L	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.
	22/7 09:27 af E L	-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.
	22/7 09:27 af E L	We've invested significantly in patient services and are rethinking our onboarding to make it seamless and flexible. Our launch will be tailored in a very different environment but with a very different approach, state-by-state, prescriber-by-prescriber. And as soon as we get the green light from FDA, we'll be ready to launch.
	22/7 09:26 af E L	It's also dosed precisely to sustain B cell depletion and it comes in a subcu injection. This has the potential to truly change how physicians treat MS in first line and first switch. Our focus in these past months has been to make it as easy as possible to prescribe and access this product.
	22/7 09:26 af Helge Larsen/PI-redaktør	:-D
	22/7 09:26 af E L	we're very much looking forward to bringing ofatumumab to market. And we believe the FDA now has all the data they need to give us the green light. What is most compelling about ofatumumab is that it can give patients the possibility to live relapse-free for 9 to 10 years. What ofatumumab does is it effectively depletes B cells. This is the most efficacious way to treat MS. We've also developed this product specifically for MS with a favorable safety.
	22/7 09:25 af E L	hahaha, I can't say no anymore now, can I? Lazy Danes :-D
	22/7 09:20 af Helge Larsen/PI-redaktør	Then we will have the information in the chat-history. :-)
	22/7 09:19 af Helge Larsen/PI-redaktør	It´s ok to do it. :-)
	22/7 09:02 af E L	a few more comments on Ofa there, but maybe a bit too much to paste all here
	22/7 09:00 af E L	Transcript of Novartis earnings call (link) When you look at our late-stage pipeline, just to go through some of the key assets in detail, ofatumumab, we continue to have very good discussions with FDA. We're on track for our action date in September of 2020, no major issues. And happy to, of course, answer any questions, but we feel very good about where we are in that discussion and the ongoing label negotiation.
	22/7 07:46 af Stroka	Genmab i rekord får lagt 18,5 pct. til kursmålet hos Bernstein 06:40 Det amerikanske finanshus Bernstein har løftet sit kursmål for Genmab med 18,5 pct. til 2275 kr. fra 1920 kr. Samtidig holdes der fast i den positive anbefaling outperform, fremgår det af data fra Bloomberg News. Genmab-aktien er - ligesom store dele af det danske marked - inde i en god periode lige nu, og tirsdag sluttede aktien atter i rekord, da den steg med 0,1 pct. til 2340 kr.
	22/7 07:10 af bibob	FDA approval sought for Selinexor in Myeloma after 1 prior line of therapy. (link)
	22/7 06:59 af bibob	God morgen. :-)