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Home  /  Forum  /  BioPharma  /  Genmab, de Deense parel

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Genmab, de Deense parel

145 Posts
Pagina: «« 1 ... 3 4 5 6 7 8 »» | Laatste | Omlaag ↓
  1. [verwijderd] 3 augustus 2007 10:13
    GENMAB REGAINS RIGHTS TO HUMAX-TAC
    Copenhagen, Denmark; August 2, 2007 – Genmab A/S (OMX: GEN) announced today it has regained all rights to the HuMax-TAC™ antibody from Merck Serono following a portfolio review by Merck Serono. Worldwide rights to HuMax-TAC were previously licensed to Merck Serono in May 2005. Regaining the rights to HuMax-TAC will not influence Genmab’s financial guidance for 2007.

    “Now that we have regained rights to the HuMax-TAC program, Genmab will review the program internally to decide on future plans,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

    www.genmab.com/PressCentre/RecentNews...

  2. [verwijderd] 10 augustus 2007 17:24
    ROCHE FILES IND FOR SECOND GENMAB ANTIBODY
    Copenhagen, Denmark; August 10, 2007 – Genmab A/S (OMX: GEN) announced today that its partner Roche has filed an Investigational New Drug application (IND) with the US Food and Drug Administration for a Genmab antibody developed under the companies’ collaboration. Genmab will receive a milestone payment from Roche which does not influence Genmab’s financial guidance for 2007.



    Under the agreement with Roche, Genmab utilizes its broad antibody expertise and development capabilities to create human antibodies to a broad range of disease targets identified by Roche. Genmab receives milestone and royalty payments based on successful products. In certain circumstances, Genmab may obtain rights to develop products based on disease targets identified by Roche. If all goals are reached, the value of the collaboration to Genmab could be USD 100 million, plus royalties.



    “This will be the second antibody produced under our collaboration with Roche to enter the clinic and Genmab’s seventh antibody to enter clinical development overall,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “Our partnership with Roche continues to bear fruit and add value to Genmab’s expanding product pipeline.”

    www.genmab.com/PressCentre/RecentNews...

  5. [verwijderd] 3 september 2007 14:20
    Genmab to Attend Three September Investor Conferences...»

    Copenhagen, Denmark; September 3, 2007 - Genmab A/S (OMX: GEN) announced today its management will attend three investor conferences in September 2007. Genmab's Chief Operating Officer, Claus Møller, M.D., Ph.D., will attend the Goldman Sachs Biotech Symposium in London on September 7. Chief Executive Officer Lisa N. Drakeman, Ph.D., will present at the Bear Stearns 20th Annual Healthcare Conference in New York on September 11 at 11:00AM local time and at the Merrill Lynch Global Pharmaceutical, Biotech & Medtech Conference in London on September 18 at 1:00PM local time.

    Dr. Drakeman's presentations will be available via live and archived webcast at www.genmab.com.

    www.genmab.com/PressCentre/RecentNews...
  6. [verwijderd] 7 september 2007 12:00

    GENMAB ANNOUNCES ENCOURAGING PRECLINICAL DATA FOR OFATUMUMAB

    Copenhagen, Denmark; September 7, 2007 – Genmab A/S (OMX: GEN) announced today that ofatumumab (HuMax-CD20(R)) appeared more effective at inducing complement dependent cytotoxicity (CDC), an immune system killing mechanism, than rituximab in a pre-clinical study. The CD20 antibodies were incubated with tumor cells and analyzed using Spinning Disk Confocal Fluorescent Microscopy. This technology allows imaging of the effects on target cells induced by therapeutic antibodies in real time. Both antibodies were found to activate CDC and induced profound changes in both shape and appearance of target cells.

    Direct comparisons of ofatumumab and rituximab revealed ofatumumab to induce much more rapid and profound CDC and far more impressive cell changes than rituximab. This, furthermore, lead to more effective killing of target cells by ofatumumab.

    “This study supports the growing body of pre-clinical research that suggests ofatumumab may be more effective in eliminating target cells and treating diseases such as lymphoid cancers and rheumatoid arthritis than existing therapies,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

    These pre-clinical data will be presented in an oral presentation at the XIth European Meeting on Complement in Human Disease, in Cardiff, United Kingdom on September 9, 2007.

    www.genmab.com/PressCentre/RecentNews...
  7. [verwijderd] 13 september 2007 12:29
    DAHANCA INITIATES HEAD AND NECK CANCER STUDY WITH GENMAB’S HUMAX-EGFR

    Copenhagen, Denmark; September 13, 2007 - Genmab A/S (OMX: GEN) announced today the initiation of a Phase III study of HuMax-EGFr™ (zalutumumab) to treat head and neck cancer in cooperation with the Danish Head and Neck Cancer Group (DAHANCA). The study will include approximately 600 previously untreated head and neck cancer patients to assess whether concomitant therapy with HuMax-EGFr can improve the efficacy of primary curative radiotherapy.

    "We are excited for DAHANCA to begin the largest HuMax-EGFr trial to date," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We hope that HuMax-EGFr provides additional benefit to head and neck cancer patients receiving radiotherapy."

    About the trial

    Patients in the study will be randomized to treatment with radiotherapy or HuMax-EGFr plus radiotherapy. All patients will receive treatment with accelerated radiotherapy plus nimorazole and may also receive cisplatin chemotherapy. Patients receiving HuMax-EGFr will receive six weekly doses of 8 mg/kg of HuMax-EGFr. Patients will be followed for at least 5 years and will be clinically evaluated at months 2, 5, 8 and 12 after completion of treatment. Evaluations will continue every 4 months in the second year and every 6 months the third and fourth year and once a year thereafter.

    The objective of the study is to determine the efficacy of HuMax-EGFr in combination with radiotherapy in treating patients with squamous cell carcinoma of the head and neck. The primary endpoint is loco-regional control and secondary endpoints are overall survival, disease free survival and acute and late side effects.

    About cancers of the head and neck

    Head and neck cancers may affect the mouth, nasal cavities, sinuses, larynx and pharynx. Most are squamous carcinomas but others include lymphoepithelioma and lymphoma. Head and neck cancers account for 3 % of all cancers in the U.S., with 40,000-60,000 cases diagnosed and 12,000 deaths annually. Worldwide incidence is about half a million with nearly 250,000 deaths.

    www.genmab.com/PressCentre/RecentNews...

  8. [verwijderd] 13 september 2007 12:30
    GENMAB ANNOUNCES ASSET EXCHANGE AGREEMENT

    Copenhagen, Denmark; September 13, 2007 – Genmab A/S (OMX: GEN) announced today the execution of an asset exchange agreement with Medarex, Inc. Under the terms of the agreement, Genmab will receive full rights to HuMax-Inflam™/MDX-018, which targets IL-8, and Medarex will receive full rights to multiple disease programs in oncology. Genmab and Medarex will release to each other all previously held economic interests in the assets exchanged.

    “Genmab will now hold all the rights to the HuMax-Inflam antibody which we have developed in cooperation with Medarex and hope to move the product into further clinical studies soon,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

    www.genmab.com/PressCentre/RecentNews...

  9. [verwijderd] 13 september 2007 12:31
    GENMAB DISCLOSES TARGET AND DEVELOPMENT PLANS FOR HUMAX-INFLAM

    Copenhagen, Denmark; September 13, 2007 – Genmab A/S (OMX: GEN) announced today its fully human HuMax-Inflam™ antibody is directed to IL-8 (interleukin-8) and may have potential application in oncology and inflammation. Genmab will initially focus on studies to treat glioblastoma, a cancer of the central nervous system. Other possible indications include chronic obstructive pulmonary disease (COPD) and pustular dermatoses. In pre-clinical studies, HuMax-Inflam has been shown to inhibit tumor growth in tumor models using primary human tumors in immunodeficient mice. HuMax-Inflam was also effective in reducing disease activity in palmoplantar pustulosis patients in a clinical study.

    Genmab is currently preparing an improved commercially viable cell line for HuMax-Inflam and hopes to start the next phase of clinical trials in 2008.

    “Genmab’s development plans for HuMax-Inflam have been a closely guarded secret for several years now and we are happy to announce the solution to the mystery, which has been much anticipated by the investment community,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We believe that HuMax-Inflam may have potential to treat patients with glioblastoma, which has a very low survival rate.”

    About HuMax-Inflam and IL-8

    HuMax-Inflam is a high affinity fully human IgG1,κ antibody directed towards IL-8. IL-8 is a major mediator of inflammation, a potent chemoattractant for white blood cells called neutrophils, as well as an important factor in angiogenesis. HuMax-Inflam effectively blocks binding of IL-8 to neutrophils and inhibits neutrophils from migrating towards sites of inflammation via a process known as chemotaxis. HuMax-Inflam also potently inhibits IL-8 induced neutrophil activation. In pre-clinical studies, HuMax-Inflam has been shown to inhibit tumor growth in tumor models using primary human tumors in immunodeficient mice.

    Results from a Phase I/II study of HuMax-Inflam in patients with palmoplantar pustulosis were reported by Genmab and Medarex in December 2004. Fifty-seven percent (16 of 28) of patients who completed the study achieved a 50% or more reduction in disease activity at week 8. In a pooled analysis of all dose groups after 8 weeks, a statistically significant reduction in disease activity of 56% was seen. In addition to effectively reducing disease activity in study patients, HuMax-Inflam was also effective at inhibiting neutrophil chemotaxis in fluids sampled from patients and the concentration of HuMax-Inflam in such fluids increased in parallel with higher treatment doses.

    Conference Call

    Genmab will hold a conference call about the news today, Thursday September 13, 2007 at:


    3:00 PM CEST

    2:00 PM BST

    9:00 AM EDT


    The dial in numbers are as follows:


    +1 800 289-0533 (in the US)

    +1 913 981-5525 (outside the US)


    The conference call will be held in English.


    A live webcast of the call will be available at www.genmab.com. The webcast will also be archived on Genmab’s website.

    www.genmab.com/PressCentre/RecentNews...

  10. [verwijderd] 14 september 2007 07:13
    GENMAB PROVIDES INSIGHTS INTO IgG4 ANTIBODIES

    Copenhagen, Denmark; September 13, 2007 – Genmab A/S (OMX: GEN) announced today its scientists have discovered the basis for the instability of human IgG4 antibodies underlying their biological role in the immune system. In pre-clinical studies, Genmab discovered that IgG4 antibodies are dynamic and unstable molecules that naturally exchange their target-binding arms with other IgG4 molecules. This exchange leads the antibody to essentially become bispecific with the potential ability to bind to two different targets. However, the IgG4 antibodies usually do not bind to two different targets simultaneously in vivo.

    This exchange of target-binding arms underlies the anti-inflammatory activity seen with IgG4 antibodies and may lead to a dampening effect on inflammatory reactions in certain conditions such as allergies or autoimmune disease. These dynamic and unstable properties make IgG4 antibodies unpredictable and thus unfavorable for human therapeutic use, in spite of their potential advantage in treating diseases for which effector function is not desired.

    These findings will be published in the journal Science on September 14. The studies were performed in collaboration with scientists at Sanquin Research, Amsterdam and the University of Maastricht, the Netherlands.

    “These insights into the mechanisms of human IgG4 antibodies are what led Genmab to develop the UniBody™ technology platform,” said Prof. Jan G. J. van de Winkel, Chief Scientific Officer at Genmab. “By removing the hinge region of the IgG4 antibody molecule, we have created a small, stable and inert half-molecule with a long half-life called UniBody which may provide effective treatments for certain types of cancer and autoimmune disease.”

    www.genmab.com/PressCentre/RecentNews...
  13. [verwijderd] 27 mei 2009 16:28
    UPDATE 1-US FDA staff question data on Glaxo, Genmab drug
    Wed May 27, 2009 10:18am EDT

    WASHINGTON, May 27 (Reuters) - U.S. drug reviewers have questioned if a proposed leukemia drug from GlaxoSmithKline PLC (GSK.L) and Genmab (GEN.CO) provides enough benefit to warrant approval, documents released on Wednesday said.

    Food and Drug Administration staff said the magnitude of anti-cancer activity in patients with chronic lymphocytic leukemia (CLL) was "difficult to quantify."

    "The major issue regarding this application is whether the effect sizes ... are reasonably likely to predict clinical benefit," FDA staff said in a memo prepared for an FDA advisory panel.

    In a separate summary, Glaxo said the drug's response rate and safety were better than available therapies for CLL patients who have failed other options. The company also said the drug, Arzerra, met the regulatory requirements for approval.

    www.reuters.com/article/marketsNe...
  16. [verwijderd] 27 mei 2009 16:43

    Credit Suisse keeps "outperform" before FDA speaks on Genmab's leukaemia drug

    26 May 2009 - Credit Suisse reiterated its "outperform" stance and the share price target of DKK370 on Danish biotech firm Genmab A/S (CPH: GEN) before an expert panel to the US Food and Drug Administration (FDA) states its opinion on the firm's drug Arzerra.

    www.m2.com/m2/web/story.php/2009FE021...
  18. [verwijderd] 29 mei 2009 18:34
    US FDA panel votes in favor of Glaxo, Genmab drug
    ORLANDO, Fla., May 29 (Reuters

    A small trial of Arzerra, which is being developed by GlaxoSmithKline PLC (LSE: GSK.L - news) and Genmab (Copenhagen: GEN.CO - news) for treating chronic lymphocytic leukemia, is sufficient for the U.S. Food and Drug Administration to approve the drug, an advisory committee to the agency said on Friday.

    The panel voted 10-3 that the trial results were likely to predict clinical benefit, with one member abstaining.

    'I am impressed by the resolution of symptoms,' said Dr. Margaret Tempero, deputy director at the University of California at San Francisco's cancer center. 'I also thought the overall survival benefit looked encouraging.'

    Glaxo and Genmab are seeking accelerated approval of Arzerra, based on results from a small trial that did not include a comparison arm.

    Initially, the companies are seeking approval for CLL patients who have failed two other treatments -- fludarabine and alemtuzumab -- and others who have failed fludarabine and for whom alemtuzumab, sold by Genzyme (NASDAQ: GENZ - news) as Campath, was inappropriate because of their bulky tumors. Keywords: GLAXOSMITHKLINE/FDA/ARZERRA

    uk.biz.yahoo.com/29052009/323/fda-pan...
145 Posts
Pagina: «« 1 ... 3 4 5 6 7 8 »» | Laatste |Omhoog ↑

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