Biotek-snakken — November 2023
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Altså når Ximluci har samme effekt som originalen, og det er jo begrundelsen for godkendelsen: The EU marketing authorization was based on data from a comparative analytical assessment and a phase 3 clinical trial that demonstrated similar safety and efficacy profiles between the Ximluci and the reference product in patients with wet AMD. The study involved 580 patients and the primary end point was the change in best corrected visual acuity at week 8 from baseline.
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The study achieved the primary end point as the adjusted treatment differences between the products were within the predefined equivalence margin.
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Erfaringen tilsiger at læger er enormt konservative og at det tager lang tid, at komme ind med et alternativt produkt til en eksisterende.. på den anden side, - og det er jo casen i en julenøddeskal, bør der komme en udvikling, som hjælper billigere produkter i markedet. Ellers drukner staterne i healthcare. Nu er muligheden der, med similars. Hvis staterne ikke hjælper til, er der ingen der gider investere i det i fremtiden…
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@exitnu: Markedsføringstilladelsen blev udstedt af EU i 2022. Hvordan Xbrane in- og eksternt, har brugt den efterfølgende tid, skal jeg ikke gøre mig klog på. De kommende faktuelle salgstal bliver uden tvivl vigtige for kursudviklingen. Jeg ejer ikke selv aktien.
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Godmorgen
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Xbrane Biopharma releases Interim report for January – September 2023:
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Tja, indtægterne stiger pænt, men det gør udgifterne så også
Vel fornuftigt nok at begrænse udgifterne, så de kan nå målet om at blive cash positive senest i Q1 2025. FIRST NINE MONTHS 2023*
• Revenue amounted to SEK 171.8 m (40.3). -
Nogen der har tal på hvad de havde forventet af omsætning på nuværende tidspunkt?
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Calliditas initiates clinical study to evaluate setanaxib in Alport Syndrome:
Calliditas Therapeutics AB
Calliditas is a commercial stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.
Calliditas Therapeutics AB (www.calliditas.se)
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Xbrane Biopharma Q3 2023: Slightly higher revenues and softer EBIT:
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