Biotek-snakken — April 2024
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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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Genovis AB: Genovis årsredovisning 2023 publicerad:
https://investor.genovis.com/wp-content/uploads/Genovis_AR_2023_Sv.pdf
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Calliditas Announces Positive NefIgArd Open Label Extension Results
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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Også muligt med et Kinpeygo-svar fra EMA i denne uge:
https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-22-25-april-2024_en.pdf
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