Biotek-snakken — December 2019
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Er der kommet et nyt kursmål på Hansa Biopharma siden oppdateringen den anden dag. Eller er det dit personlige kursmål Nadia6111. Bare for oppklaring (-:. Når man høre konferencen fra den anden dag så bliver der sagt at fase 3 forsøget i USA ikke kommer til at ender på deres finansielle guiding. Men betyder det at de ikke må hente penge ? Deres kassebeholdning ser ikke ud til at være stor nok til at køre fase 3 mm frem til 2023. Eller regner de med nok indtægter fra Europa.
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Orphazyme får amerikansk særstatus i endnu en indikation
Biotekselskabet Orphazyme kan se frem til en række regulatoriske fordele i det videre arbejde med hovedkandidaten arimoclomol, der har fået endnu en særstatus - denne gang mod muskelsvindssygdommen sIBM.
(medwatch.dk)
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Spændende år Orphazyme går ind i.
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Photocure (PHO) : Studieresultat er netop offentliggjort https://www.marketscreener.com/PHOTOCURE-ASA-1413243/news/Photocure-Reduced-recurrence-after-flexible-Blue-Light-Cystoscopy-with-Hexvix-in-surveillance-Ne-29748393/
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Hansa Biopharma: https://www.proinvestor.com/debat/80265
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U.S. Food and Drug Administration granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers. https://www.fda.gov/news-events/press-announcements/fda-approves-new-type-therapy-treat-advanced-urothelial-cancer
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Interstitial lung disease is a very important side effect to monitor and be vigilant for, but KOL is concerned that practitioners are going to be hyper-vigilant and patients will be taken off a drug that's very active because of an inflated perception of interstitial lung disease
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"There's absolutely no comparison. You wouldn't see a response rate this high in the third- or fourth-line setting. Once you get past first- and second-line therapy, you're seeing response rates in the 20% to 30% range at best. The response rate for trastuzumab deruxtecan was so high [61%] with progression-free survival for so long [16.4 months], that it knocks all other therapies out of the park."
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Der er bekymringer omkring bivirkningsprofilen (bl.a. ILD) og det er jo her at ZW49 virkelig gerne skulle vise sit værd, da det jo bevidst er dette Zymeworks er gået efter. Så lad os håbe på at ZW49 har effekt som DS8201 og en langt bedre bivirkningsprofil, så bliver det rigtig sjovt
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