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Aandeel Gilead Sciences OTC:GILD, US3755581036

  • 59,970 26 okt 2020 20:59
  • -0,820 (-1,35%) Dagrange 0,000 - 0,000
  • 1.695 Gem. (3M) 9,6M

Remdesivir

125 Posts
Pagina: «« 1 2 3 4 5 6 7 »» | Laatste | Omlaag ↓
  1. forum rang 6 Endless 28 augustus 2020 23:12
    FDA OKs emergency use of Gilead's remdesivir for moderate COVID-19

    Aug. 28, 2020 4:56 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
    Gilead Sciences (NASDAQ:GILD) announces the FDA emergency use nod for Veklury (remdesivir) for the treatment of hospitalized COVID-19 patients with moderate pneumonia.

    It was approved for the emergency treatment of severely ill patients on May 1.

    The expanded use was based on results from the Phase 3 SIMPLE study and an NIAID trial in hospitalized patients with a range of disease severity.

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  2. forum rang 6 Endless 2 september 2020 17:51
    New analysis of COVID-19 studies show mortality benefit of inexpensive steroids

    Sep. 2, 2020 11:33 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
    A meta-analysis of pooled data from seven completed studies involving 1,703 critically ill COVID-19 patients showed that the administration of corticosteroids reduced mortality compared to standard-of-care (SOC) treatment. The results were just published online in Journal of the American Medical Association (JAMA).

    Patients were randomized to receive systemic dexamethasone, hydrocortisone or methylprednisolone on top of SOC treatment or placebo + SOC. The primary outcome measure was all-cause mortality 28 days after randomization.

    The overall 28-day all-cause mortality rate was 38.0% (n=647/1,703). The mortality rate in patients receiving corticosteroids was 32.7% (n=222/678) compared to 41.5% (n=425/1,025) in those receiving SOC only, implying a 21.2% relative reduction in mortality risk. Results were consistent across the studies.

    Results from an Oxford University-led study, RECOVERY, reported almost three months ago, showed a similar mortality benefit from dexamethasone in severely ill patients on ventilators, cutting the risk of death by 28 - 40%. Mortality risk was reduced by 20 - 25% in COVID-19 patients receiving supplemental oxygen. It did not appear to help patients with milder symptoms.

    These corticosteroids have been off patent for years and are available at low prices worldwide. In England, for example, a 10-day regimen of dexamethasone only costs ~£5 per patient. In the U.S., a 10-tablet regimen of dexamethasone is available for ~$6, prednisone for a bit less.

    By comparison, Gilead Sciences' (GILD +1.1%) Vektury (remdesivir) costs $390/vial or $2,340/five-day course.

    A Phase 3 study, SIMPLE-Severe, showed a mortality rate of 7.6% at day 14 in severely ill COVID-19 patients receiving remdesivir + SOC compared to 12.5% for SOC alone, implying a 39.2% relative reduction in mortality risk (the company reported 62% less risk based on an adjusted odds ratio of 0.38. This approach holds other variables constant and provides the odds ratio for the variable of interest, in this case, mortality).

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  3. forum rang 6 Endless 10 oktober 2020 18:36
    COVID-19-onderzoeken gaan snel door, meer dan 2.000 lopende / geplande

    10 oktober 2020 12:30 uur ET|Over: Gilead Sciences, Inc. (GILD)|Door: Douglas W. House , SA Nieuwsredacteur
    Het aanhouden van de wereldwijde pandemie van het coronavirus heeft het voorspelbare effect gehad op de inspanningen om effectieve behandelingen en vaccins te vinden. Een vraag in ClinicalTrials.gov onthulde dat er 2.015 COVID-19 interventionele (een behandeling betreft) klinische onderzoeken zijn die momenteel actief, voltooid of gepland zijn. Slechts acht hebben definitieve resultaten opgeleverd.

    304 worden vermeld als fase 1, 767 fase 2 en 450 fase 3 (de rest wordt gecategoriseerd als "niet van toepassing", dit zijn doorgaans onderzoeken die onafhankelijk worden uitgevoerd door onderwijsinstellingen, onderzoeksorganisaties, medische onderzoekers, enz.). 534 studies worden gefinancierd door de industrie. 50 proeven worden gefinancierd door de NIH of een ander Amerikaans federaal agentschap.

    Er zijn 21 onderzoeken die Gilead Sciences testen ' (NASDAQ: GILD )Veklury (remdesivir) die ofwel aan het rekruteren zijn, actief zijn, niet rekruteren of nog niet rekruteren. 12 zijn fase 3.

    Met deze hoeveelheid onderzoeken zullen er volgend jaar en daarna voldoende gegevens worden uitgelezen.

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  4. forum rang 6 Endless 16 oktober 2020 07:22
    www.gilead.com/-/media/gilead-corpora...
    GILEAD SCIENCES STATEMENT ON THE SOLIDARITY TRIAL
    We are aware that initial data from the World Health Organization’s (WHO) SOLIDARITY Trial has been made public prior to publication in a peer-reviewed journal. The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury® (remdesivir). We are concerned that the data from this open- label global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design. The SOLIDARITY Trial is a multi-center, open-label global trial that provided early access to Veklury, among other investigational COVID-19 treatments, to patients around the world - particularly in countries where ongoing trials of investigational treatments were not available. The trial design prioritized broad access, resulting in significant heterogeneity in trial adoption, implementation, controls and patient populations and consequently, it is unclear if any conclusive findings can be drawn from the study results.
    The benefits of Veklury have been demonstrated in three randomized, controlled clinical trials, including a randomized, double-blind, placebo-controlled clinical trial (ACTT-1) – the gold standard for evaluating the efficacy and safety of investigational drugs. The results from the National Institute for Allergy and Infectious Diseases (NIAID)’s ACTT-1 trial, which was conducted primarily in the United States and Europe, found that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments in hospitalized COVID-19 patients. These data were peer-reviewed and published in the New England Journal of Medicine and have supported Veklury’s inclusion in multiple treatment guidelines. These data have also supported regulatory approvals or temporary authorizations to treat COVID-19 in approximately 50 countries worldwide. Additionally, we are pleased that today WHO has prequalified remdesivir, which assures procurement agencies such as the United Nations that Veklury has met global standards of quality, safety and efficacy.
    Important Information about Veklury in the United States
    Veklury has not been approved by the U.S. Food and Drug Administration (FDA) for any use, and its safety and efficacy have not been established. Gilead submitted a new drug application for Veklury on August 7, 2020; the NDA is currently under FDA review. Veklury is currently authorized for temporary use under an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with COVID-19, including patients with moderate to severe disease, regardless of the need for supplemental oxygen. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of Veklury and mandatory requirements of the EUA in the U.S., please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.
    Media Contact:
    Sonia Choi (650) 425-5483
  5. forum rang 6 Endless 22 oktober 2020 22:07
    FDA OKs Gilead's remdesivir

    Oct. 22, 2020 4:01 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
    The FDA's website indicates that it has fully approval Gilead Sciences' (GILD +0.8%) Veklury (remdesivir). It does not specify the specific indication, but the company completed its rolling application in early August for severely ill hospitalized COVID-19 patients.

    The agency granted emergency use authorization for these patients on May
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