Biotek-snakken — April 2024
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BioArctic And Eisai Collaborate On Evaluating BAN2802 For Alzheimer's Disease https://www.proinvestor.com/investornyt/1148131/bioarctic-and-eisai-collaborate-on-evaluating-ban2802-for-alzheimers-disease
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En fabriksorienteret Complete Response Letter (CRL) kan typisk resultere i en forlængelse på 1 til 6 måneder, men i visse tilfælde kan forlængelsen vare op til 12 måneder eller mere.
"Receiving a complete response letter is not a rejection, but it introduces important business questions for product launch planning."
https://avalere.com/insights/what-is-a-complete-response-letter
(Avalere)
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Complete Response Letter (CRL) betyder en udfordring for Xbrane. De skal håndtere forsinkelsen, ekstra omkostninger men også en ekstra usikkerhed omkring godkendelse. Rent statistisk er høj godkendelsesraten for biosimilar ganske pæn. Har ikke Xbrane.
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Xbrane Biopharma: Ximluci – CRL
Redeye provides its initial comments on yesterday evening’s news that Xbrane has received a CRL from the FDA related to its Ximluci BLA. This means the FDA requires additional clarifications and a potential US approval will be delayed.
(Redeye)
"Given the available information, we believe that a realistic expectation for a new BsUFA date would be in the coming 6-9 months."
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Curasight får grønt lys til fase 2-forsøg mod prostatakræft https://www.proinvestor.com/investornyt/1148313/curasight-far-gront-lys-til-fase-2-forsog-mod-prostatakraeft
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Godmorgen
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