Genmab — Januar 2014
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European Medicines Agency (EMA) (www.ema.europa.eu)
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Idelalisib i CLL er også på programmet
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Mabthera (EMEA/H/C/000165/X/0083) MAH: Roche Registration Ltd, (rituximab), Rapporteur: Jens Ersbøll, PRAC Rapporteur: Doris Stenver, “Line extension to add subcutaneous route of administration: Mabthera 1400 mg solution for subcutaneous injection.”
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Arzerra (EMEA/H/C/001131/II/0023), Orphan MAH: Glaxo Group Ltd, (ofatumumab), Rapporteur: Jens Ersbøll, Co-Rapporteur: Ingunn Hagen Westgaard, PRAC Rapporteur: Doris Stenver, “Extension of indication to the first line treatment of chronic lymphocytic leukaemia in combination with alkylator-based regimens in patients not eligible for fludarabine-based therapy.
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Ser ikke ud til at Gazyva er med
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Samlet assesment på nye farmaka 210 aktive dage + 67 lovgivningsdage. Udvidelse af indikation assesment 90dage. Ser ud til vi overhaler Gazyva indenom
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Ikke meget nyt fra FF: https://www.nordnet.dk/mux/web/analys/nyheter/visaNyhet.html?itemid=293256013&sourcecode=ddk
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aktierne bliver først noterede om en uges tid - så evt §28 meddelelser kommer vel først der
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i det mindste kan FF da skrive af fra GENs materiale
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Ja, man må formode at den er clearet af med FDA i forbindelse med btd, den er nok mere risky hos EMEA
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jeg er for første gang enig med FF
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Jeg kan ikke se, hvorfor man skulle gå ud og styrke sin position med 1 mia. kr. ekstra, hvis det blot er til den almene forretningsudvikling, for det burde de have tilstrækkelige ressourcer til, siger Jyske Banks analytiker Frank Hørning Andersen til Ritzau Finans.
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Jeg kan heller ikke se det
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