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Pharming Group NL0010391025

Laatste koers (eur)

0,842
  • Verschil

    0,000 0,00%
  • Volume

    2.259.723 Gem. (3M) 5,4M
  • Bied

    0,840  
  • Laat

    0,850  
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15.953 Posts
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  1. pafrans 26 februari 2016 14:51
    quote:

    Cor S schreef op 26 februari 2016 14:48:

    Het volume moet gaan toenemen, dan zijn we er zo door heen - op naar de 10 milj.
    Vanmiddag lossen die laadblokken van zelf op. Vanmiddag begint de rally naar boven.
  2. [verwijderd] 26 februari 2016 15:03
    heb ook een telefoontje gewaagd en kreeg hetzelfde antwoord.
    Er is niemand stuur aub maar een mail...

    Ik heb gezegd dit is erg belangrijke informatie welke via Pharming moet komen, en zojuist staat het op hun site...
    nu nog een pb naar de brokers.
  3. [verwijderd] 26 februari 2016 15:03
    quote:

    dmem2 schreef op 26 februari 2016 14:39:

    [...]

    en maar negatief blijven doen.
    Nee hoor,want daar moet je het van hebben.Omzet omzet omzet.Als het niet zo is;hoor ik het wel.
  4. [verwijderd] 26 februari 2016 15:11
    Pharming Announces Positive CHMP Opinion To Change The Terms Of The Marketing Authorisation For Ruconest®
    Pharming Announces Positive CHMP Opinion To Change The Terms Of The Marketing Authorisation For Ruconest®
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    -Treatment Of HAE Attacks In Adolescents With HAE Approved-
    -IgE Testing Requirements Removed-

    Leiden, The Netherlands, 26 February 2016: Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT: PHARM) today announced that following evaluation of a dossier submitted by the Company last year, the CHMP has issued a positive opinion to the European Commission on Pharming’s request to include the treatment of HAE attacks in adolescents with HAE and to remove the requirements for rabbit IgE testing that forms part of the EU label for RUCONEST®.

    Following adoption of the CHMP opinion by the European Commission, this will mean that adolescents with HAE now also have access to (non- blood derived) recombinant C1- inhibitor therapy for the treatment of their angioedema attacks. In addition, the requirement to test HAE patients for pre-existing antibodies against rabbit dander, prior to treatment with RUCONEST and following each tenth treatment with RUCONEST, will be removed from the label. The requirement for IgE testing was a specific EU request based on a single adverse drug reaction in a study subject, who did not disclose the pre-existing rabbit allergy prior to rhC1Inh treatment. The need for testing was not required in the US as more safety data were available at the time of the Biologics License Application (BLA) and subsequent FDA-approved label in 2014.

    Prof. Bruno Giannetti, MD, PhD, Pharming’s COO commented: “This EU label change will now also give adolescent in the EU the long awaited access to treat their HAE attacks with a non- blood derived C1- inhibitor and in addition, the positive CHMP opinion confirms the well-established safety profile of RUCONEST® , based on a database of a dozen controlled clinical trials as well as more than 12,000 post-marketing doses of RUCONEST® provided to HAE patients. After adoption of the CHMP opinion by the European Commission, this will remove the burden on patients and doctors to perform testing prior to and after treatments with RUCONEST® and enable emergency treatment with Ruconest® for HAE attacks in previously untreated HAE patients. HAE patients previously dependent on plasma derived C1INH therapies, including adolescents, will be able to receive RUCONEST® with the benefit of eliminating risks of exposure to known blood borne pathogens, such as Hepatitis A, B, C, E, HIV, and CJD, as well as continuously (re)-emerging pathogens, such as the recent ZIKA virus.”
  5. [verwijderd] 26 februari 2016 15:15
    quote:

    Hoopmazzel schreef op 26 februari 2016 15:03:

    [...]

    Nee hoor,want daar moet je het van hebben.Omzet omzet omzet.Als het niet zo is;hoor ik het wel.
    hoopmazzel heeft wel gelijk,
  6. [verwijderd] 26 februari 2016 15:18
    quote:

    tb alrac schreef op 26 februari 2016 15:10:

    [...] publicatie aan de late kant hoor
    Krijg hem net via de mail binnen Carla.Dus te laat.
  7. forum rang 4 hangklok 26 februari 2016 15:19
    Dit kom je om 13.00 uur zien aankomen, dus degene die er niet in zit, het kan nu nog goedkoop. Maandag zeker over de 0,30
15.953 Posts
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