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Home  /  Forum  /  BioPharma  /  Genmab, de Deense parel

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Genmab, de Deense parel

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3.511 Posts
Pagina: «« 1 ... 71 72 73 74 75 ... 176 »» | Laatste | Omlaag ↓
  2. Omegaplan 17 november 2017 08:27
    Company Announcement

    Genmab to receive milestone payment of USD 50 million in DARZALEX collaboration
    Milestone triggered by sales of DARZALEX reaching USD 1 billion in a calendar year
    Copenhagen, Denmark; November 17, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that it has achieved a USD 50 million sales volume milestone in its DARZALEX® (daratumumab) collaboration with Janssen Biotech, Inc. The milestone was triggered by confirmation by Janssen that sales of DARZALEX reached USD 1 billion in a calendar year. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize DARZALEX.

    "We continue to be pleased with the rapid uptake seen with DARZALEX since its initial launch and approval and are excited to have reached the USD 1 billion sales milestone," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

    The milestone was included in Genmab's 2017 financial guidance published on November 14, 2017
  5. [verwijderd] 17 november 2017 20:43
    @juargo: Mijlpaal is afgelopen week gehaald volgens informatie J&J.

    Het dal is gelukkig volledig gemanipuleerd door Blackrock en duid ook weer op de potentie van Genmab.

    Gerucht over een verkoop van +-4000DKK (of dit nu 3k of 5k zal worden is om het even) is alleen maar mooi voor ons als investeerders. Ook als er geen verkoop zal zijn dan is het rustig zitten blijven tot de groei vanuit Genmab gerealiseerd zal worden.
  10. Juargo 21 november 2017 13:21
    ir.genmab.com/releasedetail.cfm?Relea...

    Genmab Announces European Regulatory Submission for Daratumumab in Front Line Multiple Myeloma
    PDF
    Company Announcement
    Application to broaden label for daratumumab in front line multiple myeloma submitted to EMA
    Submission based on data from Phase III ALCYONE study
    Genmab to receive USD 3 million in milestone payments from Janssen
    Copenhagen, Denmark; November 21, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation application to the European Medicines Agency (EMA). This application seeks to broaden the existing marketing authorization for daratumumab (DARZALEX®) to include use in combination with bortezomib, melphalan and prednisone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The submission of the application triggers milestone payments totaling USD 3 million to Genmab from Janssen. The milestone payments were included in Genmab's financial guidance for 2017, which was published on November 14, 2017. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
    "We are very pleased about this submission, which marks the first application for the use of daratumumab for patients with newly diagnosed multiple myeloma. We look forward to working with both Janssen and the EMA so that daratumumab can potentially become available for a broader group of multiple myeloma patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
    The submission is based on data from the Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone in front line multiple myeloma. This data will also be used as the basis for a potential regulatory submission to the U.S. Food and Drug Administration.
  11. Juargo 21 november 2017 15:17
    J&J multiple myeloma drug succeeds in first-line combination study
    Bill Berkrot
    (Reuters) - Johnson & Johnson’s blockbuster multiple myeloma drug Darzalex when added to a standard therapy regimen reduced the risk of disease progression or death by 50 percent compared with the standard therapy alone in patients not previously treated for the blood cancer, according to data released on Tuesday.

    The data could lead to approval of the Darzalex combination as an initial, or first-line, therapy for multiple myeloma, providing a larger sales opportunity for the medicine, one of J&J’s most important growth drivers.

    Darzalex, a biotech drug known chemically as daratumumab, is already approved in combination with other medicines or alone in patients who had received one or more prior treatment regimens.
  12. Omegaplan 21 november 2017 16:11
    Media Release

    Late-breaking abstract accepted for oral presentation
    Data from Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone in front line multiple myeloma
    Copenhagen, Denmark; November 21, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that data from the Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) versus VMP alone treating newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplantation (ASCT), which was submitted by our collaboration partner Janssen Biotech, Inc., was accepted as a late-breaking abstract for oral presentation at the 59th Annual Meeting of the American Society of Hematology (ASH). The abstract is published online on the ASH website: www.hematology.org.

    This data will be presented as part of the Late-Breaking Abstracts Session on December 12, 2017 at 8:15 AM EST (2:15 PM CET).

    "We are very pleased that the exciting ALCYONE data in front line multiple myeloma has been chosen as one of the Late-Breaking abstracts to be presented at this year's prestigious ASH annual meeting, which shows that treatment with daratumumab reduced the risk of disease progression or death by 50%, compared to those in the study who did not receive daratumumab" said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
  13. [verwijderd] 21 november 2017 16:56
    Ook vandaag weer een klein voorbeeld van: er zit nog heel veel in het vat, alleen al wat betreft Darzalex. Geduld en een sterke maag (sterke koersfluctuaties) zullen over aantal jaren iets heel moois opleveren. J&J lijkt vastbesloten van deze blockbuster een megablockbuster te maken. Sterk product + global marketing-& sales powerhouse.
  14. Omegaplan 21 november 2017 17:18
    Company Announcement

    sBLA submitted to U.S. FDA for daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant
    Submission based on data from Phase III ALCYONE study
    Copenhagen, Denmark; November 21, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc., has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the use of daratumumab (DARZALEX®) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

    "We are extremely pleased that submissions have now been made in both the U.S. and Europe for daratumumab to treat patients with newly diagnosed multiple myeloma. We believe these submissions exemplify the further potential of daratumumab, and we look forward to working with both Janssen and the FDA to bring DARZALEX to a wider group of multiple myeloma patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

    A request for Priority Review has been submitted by Janssen with this sBLA. The FDA will inform Janssen whether a Priority Review has been granted within the next 60 days. If the FDA grants Priority Review, the review should be completed within 6 months from today.

    The submission is based on data from the Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone in front line multiple myeloma. Janssen also submitted a Type II variation application for daratumumab in this indication to the European Medicines Agency (EMA).
  16. [verwijderd] 22 november 2017 12:11
    Sales cijfers USA zijn uit: USD 91 mln...17% up t.o.v. September. Benieuwd naar progressie in rest van wereld. In loop van 2018 krijgen we meer gevoel bij de groei(versnelling) naar verdere toekomst toe. Hoe dan ook, als dit zo doorzet in november/december zitten we denk ik aan bovenkant van de eerder door Genmab afgegeven range.
  18. [verwijderd] 22 november 2017 13:38
    Juargo, USA sales cijfers altijd maand vertraagd, dus rond 3e week januari en volledige cijfers wereld zal bij Q4 2017/heel 2017 release zijn van J&J....effe googelen bij jaarcijfers 2017 J&J. dan zal Genmab er ook ongetwijfeld een pers release aan wijden, plus ook meenemen in hun 2017 rapporteringscijfers...maar pas nadat J&J heeft gerapporteerd. Dus, gaat nog een maand of 3 a 4 duren...nog even geduld dus.
  20. Genmob 22 november 2017 16:00
    Op het andere forum wordt veel gesproken over Investor AB, het bekende investment vehikel van de Zweedse familie Wallenberg. Zij zouden continue zwaar aan het verkopen zijn en mede de oorzaak zijn voor de heftige daling cq het gelimiteerde herstel, zelfs bij positief nieuws. Voor zover bekend hebben zij echter geen shortpositie. Ik meen ze in het verleden ook wel eens te hebben gezien als één van degenen die een behoorlijk pakket bezitten/bezaten. Ken echter de historie, huidige motivatie of verdere achtergond t.a.v. hun involvement met Genmab niet....
    Iemand die hier meer over weet en kan vermelden?
3.511 Posts
Pagina: «« 1 ... 71 72 73 74 75 ... 176 »» | Laatste |Omhoog ↑

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