Genmab — Marts 2016
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The application is based on the results from a Phase III study, COMPLEMENT 2, which evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL. Top-line results from this trial were reported in April 2015. The study met the primary endpoint with a median progression free survival in patients receiving ofatumumab in combination with FC of 28.9 months compared to 18.8 months in patients receiving FC alone (HR =0.67, p=0.0032).
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"Today's regulatory submission in Europe brings us another step closer to making ofatumumab available to a wider group of patients with relapsed CLL and we look forward to the EMA's response," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab
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Det var svært at nå før slutauktionen.
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Børsen fik den hurtigt på: http://penge.borsen.dk/artikel/1/321262/genmab_vil_have_udvidet_arzerra-godkendelse_i_europa.html
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Hermed ordret oversættelse (i hvertfald så tæt på som jeg lige kan komme):
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Van Winkel ignites the fire by referring to the fact that January was the worst month ever for biotech. “This is a good moment to get onboard”. He subsequently continues to appraise his company Genmab that has a fabulous drug with its cancer medicine Darzalex.
The market has acknowledged Genmab as ripe for takeover for two years now. Van der Winkel is not declining (or taking away / putting away / opposing) the rumors. He, to the contrary, refers to the takeover of Pharmacyclics by Abbvie for 2 -
21B USD. Johnson and Johnson were outsmarted by this a year ago. Van de Winkel: “J&J won’t let this happen once more. They, on top of this, have 35B “stored” overseas. A takeover is becoming more and more appealing to them”.
“Not that I want to let go of Genmab” he continues. But if it comes that far, then it will be a friendly takeover. However, I expect a premium of 100% on the current share price.” -
Og det var så af de mest følsomme oplysninger i Hollandsk artikel...
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Jeg ved ikke, om det er en DuoBody.??..https://clinicaltrials.gov/ct2/show/NCT02454270?term=JNJ-64052781&rank=1
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Tak. Jeg er sådan set med på, at Jan har oplyst, at EM1 er startet. Jeg googlede så bare lidt, da jeg egentlig undrer mig lidt over, hvorfor de vælger kun at starte op i Syd Korea. Og ifølge CT (der ellers er opdateret for nylig) er der ingen rekrutterende klinikker endnu. Nå, men så faldt jeg bare i farten over denne anden. Tak for info.
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) Protein in Subjects With Relapsed or Refractory B-cell Malignancies
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