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Kiadis Pharma« Terug naar discussie overzicht

Kiadis Pharma januari 2018.

1.753 Posts
Pagina: «« 1 ... 34 35 36 37 38 ... 88 »» | Laatste | Omlaag ↓
  1. Kogovus 17 januari 2018 16:39
    quote:

    Windkracht schreef op 17 januari 2018 16:32:

    220k verhandeld in de laatste twee uur, erg fors!
    Koper en verkopers, dat houd het momentum en de interesse erin. Volatiliteit is belangrijk. Je hebt het de laatste maanden gezien waar de koers door maar niet hoger en lager wilde, boksen tegen de acht maar geen kracht door lage volatiliteit.

    Mag van mij zo wel een tijdje doorgaan, langzaam omhoog met mooie pieken en dalen, elke dag weer een stapje.

    Als we vandaag boven het slot van gisteren, 8,85, mogen sluiten ben ik tevreden.

    Gr. Ko
  2. [verwijderd] 17 januari 2018 16:44
    Het duurt niet lang meer dan gaat het gebeuren kiadis op eigen kracht naar de 15 euro dan het bod van een grote pharma bedrijf dan wordt dit mijn 3 overnamen bedrijf in 6 mnd (gemalto en tigenix) lekker tocht ben nu vol ingestapt succes allemaal PS ben er tijdig bij je weet maar nooit morgenvroeg!!!
  3. Windkracht 17 januari 2018 16:56
    www.novartis.com/news/media-releases/...

    Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
    Jan 17, 2018
    Filing acceptance marks second Priority Review granted to Kymriah by the FDA for two distinct indications, underscoring the potential of first ever FDA-approved CAR-T therapy

    EMA granted accelerated assessment to Kymriah for children, young adults with r/r B-cell ALL and adults with r/r DLBCL who are ineligible for autologous stem cell transplant

    Novartis is working closely with the FDA and EMA to make Kymriah available to more patients with critical unmet need
    Basel, January 17, 2018 - Novartis today announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by the US Food and Drug Administration (FDA) for Priority Review. In addition, the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Authorization Application (MAA) for Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r DLBCL who are ineligible for ASCT. Priority Review and accelerated assessment are granted to therapies which may provide a significant improvement in the safety and effectiveness of the treatment of a serious disease, and the designations are intended to expedite the standard review time. If approved by the FDA and EMA, Kymriah would represent the first chimeric antigen receptor T cell (CAR-T) therapy available for two distinct indications in non-Hodgkin lymphoma and B-cell ALL.

    Kymriah became the first CAR-T cell therapy to receive regulatory approval when it was approved by the FDA in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse.

    "The first approval of a CAR-T therapy truly redefined the future of the cancer treatment landscape, and we are only at the beginning of this new era in cancer care," said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development. "The Priority Review designation and accelerated assessment signal that the FDA and EMA have recognized the potential of Kymriah to provide a much-needed therapeutic option for these patients with relapsed or refractory B-cell ALL and DLBCL. We are now focused on working with these regulatory agencies to bring this potentially transformative therapy to more patients."

    Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer. Kymriah uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular expansion and persistence. In 2012, Novartis and the University of Pennsylvania (Penn) entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers.

    The regulatory applications in the US and EU are based on data from the Novartis-sponsored global clinical trial program of Kymriah in children and young adults with r/r B-cell ALL and adult patients with r/r DLBCL demonstrating the efficacy and safety of Kymriah across studies. Results from the pivotal phase II JULIET clinical trial served as the basis of the sBLA and MAA (applications submitted by pharmaceutical companies to health authorities when seeking approval of a new product) for Kymriah in adult patients with r/r DLCBL. Results from the pivotal phase II ELIANA study were submitted as part of the MAA for Kymriah in children and young adults with r/r B-cell ALL.

    JULIET is the first multi-center global registration study for Kymriah in adult patients with r/r DLBCL. JULIET is the largest study examining a CAR-T therapy in DLBCL, enrolling patients from 27 sites in 10 countries across the US, Canada, Australia, Japan and Europe, including: Austria, France, Germany, Italy, Norway and the Netherlands. Data from the six-month primary analysis of JULIET were presented at the annual meeting of the American Society of Hematology (ASH) in December 2017.

    ELIANA is the first pediatric global CAR-T cell therapy registration trial, examining patients in 25 centers in the US, Canada, Australia, Japan and the EU, including: Austria, Belgium, France, Germany, Italy Norway, and Spain.

    Novartis plans additional regulatory submissions for Kymriah in pediatric and young adult patients with r/r B-cell ALL and adult patients with r/r DLBCL beyond the US and EU in 2018.
  4. Kogovus 17 januari 2018 17:04
    quote:

    Windkracht schreef op 17 januari 2018 16:57:

    De snelheid van berichtgeving omtrent CAR-T (nieuws, goedkeuring, overnames) neemt steeds grotere vormen aan. KIADIS gaat knallen!!
    Hoop is een uitgestelde teleurstelling dus ga ik er gewoon vanuit dat je gelijk krijgt WK, zou mooi zijn.

    Gr. Ko

    Edit: maar vooralsnog rond de 9.00 dansen.
  5. Kogovus 17 januari 2018 17:48
    quote:

    Barend-B schreef op 17 januari 2018 17:42:

    [...]

    Ik waardeer je inzicht, maar deze keer zit je er een keer naast ;)
    Dansen rond de 9, wees niet verbaasd, verwonder u slechts, als dit het patroon voor de eerst komende week of zo blijft.

    In ieder geval 0,15 erbij met een uitschieter naar de 9,25. Met het nemen van kleine stapjes leer je ook hardlopen. ;-)
1.753 Posts
Pagina: «« 1 ... 34 35 36 37 38 ... 88 »» | Laatste |Omhoog ↑

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