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Aandeel Galapagos AEX:t20925, BE0003818359

  • 56,890 24 jun 2021 10:38
  • -1,340 (-2,30%) Dagrange 56,760 - 58,390
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GLPG0634 (Filgotinib)

877 Posts
Pagina: «« 1 ... 38 39 40 41 42 ... 44 »» | Laatste | Omlaag ↓
  1. forum rang 6 harvester 14 januari 2021 09:51
    quote:

    de tuinman schreef op 28 december 2020 22:38:


    [...]

    Bedankt voor je antwoord.
    Lokale vertegenwoordiger...... klinkt bijna als beledigend gezien het feit dat Galapagos Filgotinib volledig ontwikkeld heeft.


    ach het is gewoon het gevolg van de oude deal.
    Galapagos verkocht de wereldwijderechten voor een royalty.en mag vervolgens helpen bij de verkoop en is in enkele landen de locale alleenvertegenwoordiger.

    Just part of the first great deal met Gilead, waar de 2e deal op volgde.
    Persoonlijk denk ik dat Galapagos (door Michele Manto en meer flexibiliteit in sales bonussen direct gelinkt aan EU markt) succesvoller was met de opbouw van het verkoop team in Europa dan Gillend en dat daarom Gilead wel oren had naar heet benoemen van Galapagos als Europese distributeur.

    Die verkopers van Galapagos steken het heus niet onder stoelen of banken dat het een In EU en door het Europees bedrijf Galapagos ontwikkeld product is.
  2. forum rang 4 winx09 15 januari 2021 09:23
    quote:

    winx09 schreef op 28 november 2020 12:32:


    [...]

    btw, iemand een idee waar Divergence1 (NCT03046056) blijft ?



    Bijzonder. Gister verscheen 1 secondary endpoint op de sheet. We missen de primary endpoint, resultaten voor de 100mg en 32 patiënten.

    Er zullen dus wel geen pb´s met resultaten van Divergence 1 &2 komen.

    Wat is de boodschap van de disclaimer onder aan de sheet (10) ?
  3. forum rang 6 Wall Street Trader 15 januari 2021 10:32
    quote:

    winx09 schreef op 15 januari 2021 09:23:


    [...]

    Bijzonder. Gister verscheen 1 secondary endpoint op de sheet. We missen de primary endpoint, resultaten voor de 100mg en 32 patiënten.

    Er zullen dus wel geen pb´s met resultaten van Divergence 1 &2 komen.

    Wat is de boodschap van de disclaimer onder aan de sheet (10) ?


    Lama Daila asked the same question to Bertrand Delsuc.

    At the bottom of the slide “DIVERGENCE1 was stopped early”. I don’t remember if this was communicated yet. I see at the start of the study 100 patients anticipated and now 78 actual.

    Bertrand Delsuc replied

    It was, on clinicaltrials.gov. When COVID started, they closed the enrollment early in February and never re-opened it, not a big deal.
    A lot of companies have been doing this for their early stages studies in the past months.
  4. forum rang 4 winx09 15 januari 2021 10:45
    @WST
    Timeline does not fit with Covid.
    Divergence 1 nummer of participants was altered 24 february 2020. Covid was just appearing on the radar of most. imho Covid could not have been the reason.
    Divergence 2 number of participants was altered 26-august 2020 (could be covid related)


    btw indeed it was already noticed on the board in February. point is, why put this extra comment on the sheet. What is the intention to communicate ?
  5. forum rang 5 Lama Daila 20 januari 2021 14:19
    quote:

    Lama Daila schreef op 27 november 2020 07:48:


    [...]
    Het is niet zeker dat deze studie er gekomen is op vraag van de FDA en mocht dat toch zo zijn, dan zie ik niet de link met het al dan niet gegeven van feedback van de type A meeting.
    Deze studie zou er ook kunnen gekomen zijn op vraag van de EMA:
    www.ema.europa.eu/en/documents/produc...

    Lipids
    Treatment with filgotinib was associated with dose-dependent increases in lipid parameters, including total cholesterol, and high-density lipoprotein (HDL) levels, while low-density lipoprotein (LDL) levels were slightly increased (see section 4.8). LDL cholesterol returned to pre-treatment levels in the majority of patients who started statin therapy while taking filgotinib. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined (see section 4.2 for monitoring guidance).

    No clinical studies have been performed to investigate interactions with OATP1B1 and OATP1B3 substrates. Therefore, it cannot be excluded that co-administration of filgotinib with OATP1B1 or OATP1B3 substrates may increase their exposure and the risk of adverse events. Co-administration with sensitive OATP1B1 or OATP1B3 substrates (e.g., valsartan, statins) is therefore not recommended.

    Other medicines and Jyseleca
    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially if you use medicines that affect your immune system (such as azathioprine, ciclosporin and tacrolimus).
    It is also very important to talk to your doctor of pharmacist if you are taking any of the following:
    • medicines to treat heart failure, coronary disease or high blood pressure (such as digoxin, diltiazem, carvedilol or valsartan)
    • medicines to treat high cholesterol (such as fenofibrate or statins including atorvastatin, pravastatin or simvastatin)




    Ondertussen is deze studie “Completed”:

    clinicaltrials.gov/ct2/history/NCT046...

    Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

  6. forum rang 5 Lama Daila 21 januari 2021 08:24
    quote:

    Lama Daila schreef op 5 december 2020 10:55:


    [...]

    Binnenkort vermoedelijk het verslag van deze NICE-meeting.


    ml-eu.globenewswire.com/Resource/Down...

    www.nice.org.uk/guidance/indevelopmen...

    Provisional Schedule

    Final appraisal document 21 January 2021 - 04 February 2021
    Expected publication 24 February 2021
  7. forum rang 6 Wall Street Trader 21 januari 2021 10:21
    NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

    Why the committee made these recommendations

    Expected publication date: 24 February 2021

    People with severe rheumatoid arthritis have a number of advanced treatment
    options (biological and targeted synthetic DMARDs) available to them if their disease
    has not responded well enough to 2 or more conventional DMARDs. These
    advanced treatment options are currently not available for people with moderate
    rheumatoid arthritis.

    Clinical trials show that filgotinib with methotrexate or other conventional DMARDs is
    more effective than adalimumab with methotrexate or methotrexate alone for treating
    moderate to severe rheumatoid arthritis that has not responded well enough to 2 or
    more conventional DMARDs. It is also more effective than conventional DMARDs
    alone for treating moderate to severe active rheumatoid arthritis that has not
    responded well enough to 1 or more biological DMARDs.

    There are no trials comparing filgotinib with the full range of biological and targeted
    synthetic DMARDs in severe disease. However, an indirect comparison shows that
    filgotinib with conventional DMARDs (including methotrexate) works as well as the
    biological and targeted synthetic DMARDs recommended by NICE.

    The most likely cost-effectiveness estimates show that filgotinib with methotrexate is
    an acceptable use of NHS resources for some people with moderate and severe
    rheumatoid arthritis (see sections 1.1 to 1.3).

    The cost effectiveness of filgotinib monotherapy is more uncertain but is still likely to
    be within what NICE considers an acceptable use of NHS resources, therefore it is
    recommended.

    www.nice.org.uk/guidance/gid-ta10541/...
  8. forum rang 5 Lama Daila 21 januari 2021 10:22
    www.nice.org.uk/Media/Default/About/w...

    In appendix B een mooi stappenplan van de “ STA process timelines”.
    Week 21:
    Appraisal Committee meeting to develop appraisal consultation document (ACD) or final appraisal determination (FAD). Note: CHMP positive opinion required by this point for single technology appraisal to proceed

  9. forum rang 6 Wall Street Trader 21 januari 2021 10:27
    quote:

    Lama Daila schreef op 21 januari 2021 09:09:


    Geen vermelding van de dosis die NICE aanbeveelt. Ik vermoed beide dosissen? Of hoeft NICE daar geen uitspraak over te doen en ligt dit eerder bij NHS ?



    Healthcare professionals should choose the most appropriate treatment
    after discussing the options with the person having treatment


    3.26 The committee recalled that having a range of treatment options was
    important in rheumatoid arthritis (see section 3.1). It also recalled that a
    range of biological and targeted synthetic DMARDs are already available
    for severe rheumatoid arthritis (see section 3.2). It noted that a number of
    NICE technology appraisals are currently ongoing for moderate
    rheumatoid arthritis (GID-TA10759 and GID-TA10586). The committee
    concluded that healthcare professionals should choose the most
    appropriate treatment after discussing the advantages and disadvantages
    of the treatments available with the person having treatment. If more than
    1 treatment is suitable, they should start treatment with the least
    expensive drug (taking into account administration costs, dose needed
    and product price per dose). This may vary from person to person
    because of differences in how the drugs are taken and treatment
    schedules.


    Choose the most appropriate treatment after discussing the advantages
    and disadvantages of the treatments available with the person having
    treatment. If more than 1 treatment is suitable, start treatment with the
    least expensive drug (taking into account administration costs, dose
    needed and product price per dose). This may vary from person to person
    because of differences in how the drugs are taken and treatment
    schedules.


    www.nice.org.uk/guidance/gid-ta10541/...

    Treatment pathway for moderate-severe RA and proposed position of filgotinib

    www.nice.org.uk/guidance/gid-ta10541/...


  10. forum rang 5 Lama Daila 25 januari 2021 07:32
    www.pharmastar.it/news//italia/27-nuo...

    Jyseleca op de markt in Italië vanaf 01/02:


    JYSELECA 30 cpr rev 100 mg filgotinib
    GILEAD SCIENCES AIC: 049054012 1572,14 € Cnn / RNRL on the market since: 01/02/2021

    JYSELECA 30 cpr rev 200 mg filgotinib
    GILEAD SCIENCES AIC: 049054036 1572.14 € Cnn / RNRL on the market from: 01/02/2021

    Cnn:
    pharmaboardroom.com/legal-articles/re...
    Class C(nn): separate class for centrally approved medicinal products which pricing and reimbursement decision in Italy has not yet been taken. These are not reimbursed by the SSN.

    RNRL:
    www.micromedexsolutions.com/micromede...
    RNRL: Recipe Repeated Limited with Restrictions: drugs which require a receipt done by a medical specialist or authorised medical unit. The receipt can be used just once.

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