Genmab — September 2015
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Taler vi så 8 måneder, 10 måneder eller lignende i stedet for 12-13 ?
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150 dage dvs. maks 6 måneder fra i dag af eller fra indsendelse?
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forskellen mellem BLA og NDA er om det er biologisk materiale eller et "almindeligt" compound
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Man skal dog huske at fra CHMP kommer med en anbefaling går der oftest 1-2 måneder før den endelige approval og derefter 2-3 måneder før man har godkendelser i de enkelte lande + tilskud osv. på plads
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Men jannsen har nok en hurtig og smidig maskine her
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new drug application og biologic license application ?
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det lille "s" står for om det er supplementary - dvs om der allerede er givet en approval fra FDAs side i en anden indikation
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præcis. og OPdivos hurtige approval var i 2.indikation
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så en sBLA burde alt andet lige være hurtigere end en BLA. Og pga produktionsprocessen vil en NDA være hurtigere end en BLA
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Siden dara er en BLA vil den principielt være i den langsomme gruppe - modsat vil den blive hurtigere pga unmet need
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Så vidt jeg kan gennemskue er Opdivo's godkendelse af BLA (den første gang) den hurtigste godkendelse - 3 måneder før pdufa
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Conditional marketing authorisation allows for the early approval of a medicine on the basis of less complete clinical data than normally required, if the medicine addresses an unmet medical need and targets a seriously debilitating or life-threatening disease
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European Medicines Agency (EMA) (www.ema.europa.eu)
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NDA & BLA Application NDA and BLA are applications to market a new product. NDAs are used by CDER (center for drugs) and BLAs are used by CBER (center for biologics) – The BLA requires close scrutiny of the and facilities, because of the greater products. manufacturing process variability of biological – The application will include complete reports on all studies including patient listings, analysis according to the original statistical analysis protocol (SAP) as well as any exploratory analysi
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Opdivo tog fra 26/9 - 22/12 2014 fra accept til approval i melanoma
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http://www.slideshare.net/gas25/usfda-nda-vs-bla pkt 30 og frem
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Vi kan vel håbe på approval omkring ASH
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