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EL-BILER
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11/2 09:07 af Sukkeralf |
Bulder er det ikke 6 måneder fra accept, som gerne tager et par måneder ?
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11/2 09:04 af Doublo |
God morgen ved man noget om, i hvilken grad de kvinder der responderer på Tisotumab Vedotin bliver hjulpet, bliver nogen helbredt, eller er det markant livsforlængende. Er 24% contra under 15% en væsentlig forbedring i sådanne forsøg, og hvad sker der efter varighedsrespons på 8,3 mdr. skal de så have ny behandling? er det en dyr behandling? Hvor mange kvinder få livmoderhalskræft på verdensplan, der står kun hvor mange der dør af det, er det ubehandlet eller med kemo?
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11/2 08:59 af Bulder |
Sukker, med PR bliver det senest i løbet af august.
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11/2 08:27 af Helge Larsen/PI-redaktør |
Suveræn nyhed. :-) PS: Q&A med Jan er fastsat til d. 23. marts.
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11/2 08:26 af transalp |
Go morgen. :) spænende nyheder..
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11/2 07:47 af Helge Larsen/PI-redaktør |
Torsdagens danske avisuddrag med Vestas, Flying Tiger og FLSmidth(link)
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11/2 07:45 af Helge Larsen/PI-redaktør |
Asien: Lav aktivitet og små udsving - store markeder holder lukket (link)
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11/2 07:15 af bibob |
Dejlig nyhed. Nu også på MedWatch. (link)
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11/2 07:14 af bibob |
God morgen. :-).
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11/2 00:15 af Sukkeralf |
Bulder vel først i efteråret med mindre de får RTOR
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10/2 23:39 af royal |
Nice call EL. :-)
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10/2 23:31 af Bulder |
Så hvis det går igennem, er det godkendt til sommer.
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10/2 23:28 af Bulder |
... seeking accelerated approval...
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10/2 23:26 af GeorgeBest |
Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer (link)
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10/2 10:45 af E L |
thanks ;-) So he confirms they are hoping for Tisotumab to be approved this year already, quite ambitious , we should see the filing any day now then i would think
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10/2 10:38 af JørgenVarnæs |
Thank you so much StockBull - looks like Jan is vigilant in balancing risk/investment going forwards
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10/2 10:35 af StockBull |
end of story :-)
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10/2 10:34 af StockBull |
Pink Sheet, 11 Dec, 2020.) Amivantamab was developed using Genmab's DuoBody platform and licensed to Janssen.
J&J has a full range of bispecific antibodies in development with Genmab, including teclistamab (BCMAxDC3) in early clinical development for relapsed refractory multiple myeloma and four more candidates in earlier trials.
ADVERTISEMENT
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10/2 10:33 af StockBull |
J&J recently submitted a biologic licensing application for a Genmab-developed bispecific antibody with the FDA. Amivantamab targets tumors with activating and resistant EGFR mutations and MET mutations. It is pending approval for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations, whose tumors do not typically respond to standard of care. (Also see "Keeping Track: J&J Amivantamab, Infectious Disease Agents From Iterum, VBI And Atox Submitted; Another Furoscix CRL" -
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10/2 10:32 af StockBull |
Bispecific antibodies are getting a lot of attention, although toxicity concerns remain. Genmab is developing a PD-L1x4-1BB bispecific antibody in early clinical testing in solid tumors in collaboration with BioNTech SE a collaboration dating back to 2015 that gives Genmab 50/50 commercial rights.
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10/2 10:32 af StockBull |
The most advanced candidate in the deal with AbbVie is epcoritamab (CD3xCD20), which moved into Phase III testing in diffuse large B-cell lymphoma (DLBCL) early this year. (Also see "Genmab/AbbVie’s Epcoritamab Advances As Deal Bears Fruit" - Scrip, 14 Jan, 2021.) The deal also includes two other bispecific antibody candidates developed using Genmab's DuoHexaBody and DuoBody development platforms, which Genmab expects will continue to deliver drug candidates into the pipeline.
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10/2 10:32 af StockBull |
"It's difficult to say right now which molecule it will be [that] we will hang onto 100%," he said. If it is a drug targeted to a smaller cancer indication that can be marketed optimally with a specialized sales force, then that would be an appropriate candidate to launch independently, but for a drug with broad reach like Darzalex, the exec explained Genmab will still look to partner, particularly because of the broad scope of the clinical development program.
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10/2 10:31 af StockBull |
Wealthier biotechs are gaining new leverage when it comes to deal-making, van de Winkel added. "The dynamics between smaller biotech companies and bigger players is changing right now because some of the biotech companies, like Genmab, are very well capitalized."
Genmab also plans to retain full ownership of some molecules, at least in the regions where it builds up a commercial presence.
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10/2 10:31 af StockBull |
the products. (Also see "Genmab Lands Experienced Partner AbbVie In Broad Bispecific Antibody Collaboration" - Scrip, 10 Jun, 2020.)
"At a minimum, we will ask for 50% co-ownership," van de Winkel said, pointing to the AbbVie partnership as an example of the kinds of deals Genmab hopes to mirror in the future. "That is one of the nice things about the AbbVie relationship, they were perfectly on board to do 50/50 with us.
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10/2 10:31 af StockBull |
50/50 Deals At Least
The company's commercial evolution will impact its partnering strategy going forward as Genmab looks to hold onto more commercial rights for its products and eventually launch drugs independently. For example, a rich $750m upfront deal the company signed last year with AbbVie Inc. to develop and commercialize three next-generation bispecific antibody candidates included co-commercialization rights in the US and Japan and an option to co-promote in other regions for two of th
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10/2 10:30 af StockBull |
will be lean initially, though Genmab hasn't yet provided any specific details.
"I spoke with my peers in the industry and it sometimes takes over 10 years before you have a good commercial infrastructure," van de Winkel said.
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10/2 10:30 af StockBull |
Tepezza (teprotumumab) – and Genmab receives sales royalties on all of them.
"This is probably one of our most exciting years ever for the company," CEO Jan van de Winkel said in a recent interview. "To become an end-to-end integrated biotech, a powerhouse, directly delivering new molecules to patients with the Genmab name on the vial is a big thrill for us."
The company is taking a cautious, stepwise approach to building out a commercial organization, focusing on the US and Japan. The team wi
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10/2 10:29 af StockBull |
cancer based on positive Phase II data. (Also see "Genmab And Seattle Genetics Progress Cervical Cancer ADC" - Scrip, 30 Jun, 2020.)
It is a transitional year for Genmab as it begins to build out a commercial footprint for the first time. The Danish biotech has developed several drugs that have reached the market, but those drugs have been launched by the company's partners. They include Johnson & Johnson's Darzalex (daratumumab), Novartis AGs' Kesimpta (ofatumumab) and Horizon Therapeutics plc
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10/2 10:29 af StockBull |
Several drugs developed by Genmab A/S are already on the market, but the company is planning to participate in its first commercial launch in 2021. Genmab is preparing for the US launch of the antibody-drug conjugate tisotumab vedotin for metastatic cervical cancer in the second half of the year in partnership with Seagen Inc. , if it is approved by the US Food and Drug Administration as expected.
The companies plan to file tisotumab vedotin for accelerated approval for metastatic cervical canc
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10/2 10:28 af StockBull |
I dont see any news in this article as such
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10/2 10:00 af JørgenVarnæs |
Looks interesting...
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10/2 09:58 af E L |
if anyone has access to scrip.pharmaintelligence.informa ; you can tell us if there is anything useful in this article ;) (link)
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10/2 09:51 af Helge Larsen/PI-redaktør |
Aktier/tendens: Vild regnskabsdag med A.P. Møller-Mærsk og mange andre(link)
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10/2 07:40 af Helge Larsen/PI-redaktør |
Onsdagens aviser med Demant, Danske Bank og TDC: (link)
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10/2 07:39 af Helge Larsen/PI-redaktør |
Asien: Generel fremgang men Tokyo halter efter: (link)
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10/2 06:45 af Helge Larsen/PI-redaktør |
God morgen. :-)
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9/2 17:23 af Solsen |
Det passer fint med en forventet stigning frem imod guidance
;-)
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9/2 17:08 af E L |
for what it is worth, we broke the small down-trendline from mid januari, next hurdle 2530ish, a quick move to 2650 would not surprise me when that breaks
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9/2 13:21 af kkjoel |
Shoe, hat - same, same. As long as displaying repentance in abundance.
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9/2 13:00 af Doublo |
Der er uendeligt mange fordele ved voldgift, det går hurtigere, intet kommer ud til offentligheden, parterne kan selv vælge dommerne, jurister, kommercielle personer, fagfolk med særligt kendskab til specielle brancher. Federal Arbittration Act. er forpligtet til at afvise søgsmål og henvise sagsøgerens. til voldgiftafgørelsen
i overensstemmelse med aftalen.
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9/2 12:53 af Mcjean |
:-D
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9/2 12:53 af Doublo |
I USA er voldgiftsafgørelser inappelable.
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9/2 12:53 af E L |
guys, i don't think you'll be able to resolve this difference of opinion
between yourselves. I suggest arbitrage :-D
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9/2 12:51 af kkjoel |
Jamen ok, så har jeg ikke mere at skulle have klinket. Regner med at du æder en eller anden gammel hat (eller nogen tilsvarende uindbydende), LLI, hvis der går knude i voldgiften og vi pludselig har en retssag?! ;-)
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9/2 12:43 af Mcjean |
I skotland er den bindende og kan aldrig appelleres.
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9/2 12:43 af Mcjean |
(link) Læs om reglerne i USA, Sagen kan være bindende eller ikke bindende og jeg mener den er accepteret som være bindende, altså den gælder som en retsag og kan kun meget sjældent appelleres.
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9/2 12:38 af kkjoel |
Ja Mcjean, du kan tage fejl. Og jeg kan. Specielt når ingen herinde har dyb viden om US voldgiftssager, love, retspræcedens og generelt medicin/patent-jura. Det var egentlig blot det jeg påpegede... :-)
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9/2 12:32 af kkjoel |
@LLI, vil forsøge at fastholde mit argument: hvis man er uenig i udfaldet af en voldgiftssag, _og har penge nok_, kan man vel _altid_ finde en måde at komme i retten på?! Osse selvom man har accepteret at voldgiftssagen er endelig. Man finder vel bare på en måde at opstille sagsforholdet/uenigheden på, således den ikke kan afgøres ved voldgift, men skal i retten?! Det er USA, trods alt.
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9/2 12:31 af Mcjean |
Jeg er ret skråsikker på at de ikke kan tabe begge sager og jeg er ret sikker på jeg ikke ved om de taber første tvist, men hvis de gør så kan de ikke afholde Genmab fra at få royalties til 35. Tvist nummer 2 vil kun aktiveres som en tvist hvis J&J taber første tvist, så vil de kræve at Genmab skal betale royalties efter 2030 da deres patent kun løber dertil. J&J ved udemærket godt at de ikke kan vinde begge sager det giver simpelthen ingen mening heller ikke for J&J. Jeg kan tage fejl!
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9/2 12:23 af Doublo |
okay tak for oplysningen
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