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***** GTCB 2007 ******

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  1. [verwijderd] 13 november 2007 18:04
    Pfff, Net weer 1,5 k Biomira binnen...Snap het niet: gisteren kort voor slot ongeveer 25k binnen op 0,52 en vandaag nog niets (tot daarnet)??? Er is toch al een en ander verhandeld op 0,52$???
  2. [verwijderd] 13 november 2007 19:09
    Campeone en zijn 7 verschillende handelshuizen actief, dus bij de ene kan de koers 51 zijn en bij de andere 52.

    .....§lagroom§oe§je§ for everybody.....
  3. [verwijderd] 13 november 2007 19:36
    Ja, dat weet ik Soesje maar het handelshuis waar ik onder "resorteer" was opvallend "onactief" vandaag, dus ik moest ze ff aanporren...voor de rest "no hard feelings" tegen deze beursjongens... ;)))
  4. [verwijderd] 13 november 2007 20:21




    09/04/2007
    GTC Biotherapeutics announced that the US Food and Drug Administration, or FDA, has designated ATryn a "fast track product" entitled to accelerated FDA review for the hereditary antithrombin deficiency indication. The FDA has also granted GTC permission to submit the associated Biologics License Application, or BLA, for ATryn(R) on a rolling basis. Fast track designation is provided to those products that are intended to treat serious or potentially life threatening conditions for which there is an unmet medical need. The BLA requesting marketing approval for ATryn will be submitted as sections are completed rather than waiting for all sections to be submitted together, enabling FDA review to begin sooner. GTC anticipates filing the initial sections with the FDA in the fourth quarter and completing the rolling submission after all clinical data is gathered, analyzed, and available for the BLA, which is planned to be by the end of the first quarter of 2008.

    08/06/2007
    GTC Biotherapeutics announced that its partner for ATryn in Europe, Canada and the Middle East, LEO Pharma A/S, has enrolled the first patient in a Phase II study of the recombinant antithrombin product in the treatment of disseminated intravascular coagulation, or DIC, in association with severe sepsis. Full enrollment of about 200 patients into the Phase II study is planned to take approximately 12 months with results expected to be available in the second half of 2008.

    08/02/2007
    GTC Biotherapeutics and LFB Biotechnologies, a wholly owned subsidiary of LFB S.A. (Laboratoire francais du Fractionnement et des Biotechnologies S.A.), have initiated development of a transgenically produced CD20 monoclonal antibody under the existing agreement between GTC and LFB Biotechnologies. The resulting product is expected to have target specificity similar to Rituximab (Rituxan, Mabthera) and to have relatively higher antibody dependent cell-mediated cytotoxicity, or ADCC. The existing relevant CD20 antibody patents will expire by 2014. The transgenically produced CD20 antibody is anticipated to be commercially developed for oncology and auto-immune indications. Rituximab is used in the treatment of B-cell non-Hodgkin's lymphoma, B-cell leukemia and rheumatoid arthritis. It is also under investigation for a range of auto-immune conditions such as systemic lupus erythematosus, immune thrombocytopenic purpura (ITP), and type-1 diabetes. Rituximab had worldwide sales of nearly $4 billion in 2006 and is projected to have a $5 billion market by 2010.

    07/17/2007
    GTC Biotherapeutics has been awarded a $41,000 grant from the Massachusetts Workforce Training Fund. The grant will fund 10 days of skills training in continuous improvement and Six Sigma process improvement to approximately 25 GTC employees in the areas of operations and quality. GTC has partnered with Worcester Polytechnic Institute's Corporate & Professional Education to deliver the five-course Certificate Program.

    05/24/2007
    GTC Biotherapeutics held its annual meeting of shareholders. Directors Robert W. Baldridge, James A. Geraghty, and Michael J. Landine were elected to three year terms on the board of directors. In addition, the proposed amendment and restatement of GTC's 2002 Equity Incentive Plan was approved.

    04/10/2007
    GTC Biotherapeutics has been granted a non-exclusive worldwide license from Start Licensing, Inc., a joint venture between Geron and Exeter Life Sciences, Inc., for the patents and patent applications developed by the Roslin Institute to apply nuclear transfer to the production of therapeutic proteins in the milk of transgenic animals. Nuclear transfer may be utilized, as an alternative to micro-injection, to provide schedule predictability in developing the first animal that incorporates into its genome the transgene for a therapeutic protein to be expressed in milk. Nuclear transfer may also be used to speed the development of large scale transgenic production capacity. Financial terms include an upfront payment of $200,000 to Start and a total of 278,370 shares of GTCB common stock, based on the 10-day average closing price ending April 5, divided equally between Start and Exeter. There will also be a royalty payable to Start for those products developed with the patented nuclear transfer technology. The license agreement remains in place through the last patent to expire, which is expected in 2016 for the currently issued patents.

    04/03/2007
    GTC Biotherapeutics announced the expansion of its capabilities in business and commercial development. Ashley Lawton, Ph.D., GTC's new Vice President of Business Development, will focus primarily on additional strategic partnering for our proprietary programs, including monoclonal antibodies, as well as developing partners for follow-on biologics. Rick Finnegan, GTC's new Vice President of Commercial Development, will focus on market introduction strategies for our products, including through partners.

    03/13/2007
    GTC Biotherapeutics and PharmAthene have entered into an agreement providing PharmAthene an expanded license to GTC's patent rights, which will support the further development, manufacturing, regulatory approval and commercialization process for PharmAthene's Protexia program. Protexia is a recombinant form of human butyrylcholinesterase (rBChE) produced by PharmAthene in the milk of transgenic goats. PharmAthene is developing Protexia as a pre- and post-exposure therapy for military or civilian victims of a chemical nerve agent attack. The expanded license agreement includes rights to utilize GTC's transgenic technology in the worldwide development and commercialization of Protexia for all uses. This expanded license agreement follows the recently announced agreement under which GTC is providing PharmAthene clinical supply and manufacturing services for Protexia. The financ
  5. [verwijderd] 13 november 2007 20:22
    vervolg:
    The financial terms of the expanded license agreement were not disclosed. While the utility of human plasma derived butyrylcholinesterase (hBChE) to protect against nerve agent toxicity is well documented, a major limitation hindering its commercial development has been the inability to produce commercial quantities of hBChE due to a limited availability of appropriate blood supplies, low levels of the protein in plasma, and low production yields using traditional biotechnology methods. PharmAthene's recombinant hBChE overcomes these limitations by enabling substantially larger production yields than are possible using other expression systems or through purification of the native protein from human plasma. Transgenic production and manufacturing is estimated to be capable of supplying sufficient rBChE to make Protexia available for use by the military and civilian populations.

    03/05/2007
    GTC Biotherapeutics and PharmAthene, Inc. have entered into an agreement under which GTC will provide process development and clinical supply manufacturing services for PharmAthene's Protexia program. Protexia is a recombinant form of human butyrylcholinesterase (rBChE) produced in the milk of transgenic goats, which is being developed by PharmAthene as a pre- and post-exposure therapy for military or civilian victims of a chemical nerve agent attack.

    01/03/2007
    GTC Biotherapeutics announced that the market authorization of ATryn for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency has been transferred to its distribution and development partner, LEO Pharma A/S, following approval by the European Commission. ATryn is a recombinant form of human antithrombin. Antithrombin is normally found in human plasma and has both anticoagulant and anti-inflammatory properties. The approval of the transfer of the market authorization enables LEO to enter into negotiation of reimbursement rates as part of preparing for the commercial launch of ATryn in Europe on a country-by-country basis. The initial launch is being planned for around the end of the second quarter 2007. In addition, LEO is conducting a phase II study of ATryn in Europe for the treatment of disseminated intravascular coagulation, or DIC, associated with severe sepsis. LEO has initiated the regulatory approval procedures to enable the opening of clinical sites and recruitment of patients into the study. GTC is continuing to supply the product to LEO to conduct this study.

    10/05/2006
    GTC Biotherapeutics was awarded an additional grant of $1.4 million for its CD137 monoclonal antibody program from the Small Business Innovative Research, or SBIR, program of the National Institutes of Health. The first year committed funding is approximately $780,000. This grant will fund process development, characterization of the antibody and efficacy testing in preclinical models in anticipation of future manufacturing for clinical trials. GTC in-licensed the CD137 antibody from the Mayo Clinic and obtained initial SBIR funding in 2004. The work planned under this additional grant will be performed over two years in collaboration with Dr. Scott Strome at the University of Maryland and Dr. Lieping Chen at the Johns Hopkins School of Medicine.

    10/02/2006
    GTC Biotherapeutics and LFB- Biotechnologies, a wholly owned subsidiary of LFB S.A. (Laboratoire francais du Fractionnement et des Biotechnologies S.A.) have entered into a strategic collaboration to develop selected recombinant plasma proteins and monoclonal antibodies using GTC's transgenic production platform. A Joint Steering Committee will agree on product development as well as commercialization plans. GTC will be responsible for development of the production system for the products and will retain exclusive commercial rights to the products in North America. LFB Biotechnologies will be responsible for clinical development and regulatory review of the first program of this collaboration, and will have exclusive commercial rights in Europe. GTC and LFB Biotechnologies will hold co-exclusive rights in the rest of the world to the products developed through their collaboration. The first program in this collaboration is for development of a transgenically produced recombinant form of human factor VIIa (rhFVIIa). Factor VIIa is a clotting factor in the coagulation of blood. A research program on rhFVIIa was initiated by LFB three years ago.

    08/06/2006
    GTC Biotherapeutics announced that its partner for ATryn in Europe, Canada and the Middle East, LEO Pharma A/S, has enrolled the first patient in a Phase II study of the recombinant antithrombin product in the treatment of disseminated intravascular coagulation, or DIC, in association with severe sepsis. Full enrollment of about 200 patients into the Phase II study is planned to take approximately 12 months with results expected to be available in the second half of 2008.

    08/02/2006
    GTC Biotherapeutics reported that the European Commission has granted market authorization to ATryn, GTC's recombinant form of human antithrombin, for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. Antithrombin is a naturally occurring plasma protein that has both anticoagulant and anti-inflammatory properties. GTC produces ATryn in the milk of goats that have a transgene for human antithrombin. ATryn is the first transgenically produced protein to be approved for human therapeutic use anywhere in the world. ATryn is also the first recombinant antithrombin product approved anywhere in the world and the first antithrombin product, whether recombinant or derived from the human blood supply, that has been approved through the centralized EMEA procedure for use in all 25 countries of the European Union.

    06/14/2006
    GTC Biotherapeutics received a $1 million payment from LEO
  6. [verwijderd] 13 november 2007 20:23
    vervolg:

    06/14/2006
    GTC Biotherapeutics received a $1 million payment from LEO Pharma A/S for achieving the milestone of a positive opinion on the market authorization application for ATryn from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The CHMP has recommended that ATryn, GTC's recombinant form of human antithrombin, be granted market authorization for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. Final market authorization by the European Commission, which is expected in about three months, will trigger an additional $2 million milestone payment from LEO Pharma.

    06/02/2006
    GTC Biotherapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion on the market authorization application (MAA) for ATryn, GTC's recombinant form of human antithrombin. The CHMP has recommended that ATryn be granted market authorization for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. ATryn may be given in association with heparin or low molecular weight heparin in these situations. The CHMP opinion recommends granting market authorization under the EMEA's procedures for exceptional circumstances. Final market authorization by the European Commission is expected in about three months. The positive CHMP opinion followed a defined process this week that included a review of GTC's submission of the grounds supporting re-examination of the previous opinion as well as a review of responses to specific questions posed by the CHMP to an independent expert panel composed of internationally recognized experts in the fields of hematology and hemostasis. These review activities are an integral part of the regulatory process for re-examination of a prior opinion

    Dree
  7. [verwijderd] 13 november 2007 21:10
    Vooral bij Pharming, wat (op dit moment nog) beter gevolgd wordt door de financiele wereld dan GTC zijn de lyrische woorden niet meer bij te houden. Het laagste koersdoel staat geloof ik op de 5 euro nu, en vele analisten vonden de sprong omhoog na zulk goed nieuws erg lauw.

  8. [verwijderd] 13 november 2007 21:17
    K'ben overnemende partij van Dree zijn stukjes...hahaha
    Heb ze nu alle 700 binnen (weer 100 per keer...pff), ben benieuwd wie mij die andere 9,3k zal "offreren" ;)))
    Nog steeds geen verdere Biomira stukjes ontvangen op 0,52$ tot op heden... :(
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