Biotek-snakken — Juni 2021
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Vi har nu to gange været nedlagt i dag uagtet at vores sikkerhed er helt i top. Det beklager jeg
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Medix informed Saniona that it will gather the requested information and continue discussions with the committee as soon as possible, and that it fully intends to continue to pursue the process of seeking approval for tesofensine. However, Medix advised that the continuing discussions with the committee may delay the anticipated final approval decision from COFEPRIS into 2022.
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En forsinkelse af godkendelse til 2022….vel ikke nogen katastrofe, men koster nok lidt på kursen mandag?
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Iterum kan ikke lade være: https://drive.google.com/file/d/10tez59UrLVKEhp3qkLWJ3ElZAHIS1UtE/view
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Dejlig nyhed at vågne til Jazzz, selvom det var ventet….toget kører videre…Og
Xbrane has additionally three biosimilars in its pipeline targeting SEK 100 billions in originator sales. -
- Top-line data Xplore (juli-aug 2021)
- Ansökan marknadsgodkännande EMA (aug - sep 2021)
- Ansökan marknadsgodkännande FDA (Q4 2021)
- Utlicensiering/partner för försäljning av Xlucane i Kina/Japan/Sydamerika (2021)
- Xlucane marknadsgodkännande EMA/FDA (Q3/Q4 2022)
- Försäljningsstart Xlucane (Q3/Q4 2022)
- Partner Xcimzane (Stada?) (2021)
- Bevis analytisk bioekvivalens Xcimzane i kommersiell produktionsskala (H2 2022)
- Xcimzane Fas I (H2 2022)
- Xcimzane Fas III (H1 2023)
- Godkänd Xcimzan
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Stängd affär Spherotide (Q4/Q1 2021/2022)
- Bevis bioekvivalens kommersiell produktionsskala Xdivane (2023)
- Xdivane Fas I / Fas III (2024)
- Avtal med partner som vill driva Xoncane genom slutet på preklinik/fas I/fas III
- Positivt operativt kassaflöde (vinst) 2023/2024
- Annonsering ny biosimilar (2022/2023/2024..)
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