NOVO — September 2023
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Godmorgen
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Novo indgår aftale med Ypsomed om levering af "store mængder" pennesystemer
20.9.2023 07.19 • MarketWire •
Novo Nordisk har indgået en aftale med Ypsomed om, at det schweiziskbaserede selskab skal levere "en stor mængde" pennesystemer til Novo.Det skriver Bloomberg.
Aftalen får ikke betydning for Ypsomeds finansielle forventninger i indeværende regnskabsår, men ventes at påvirke salget fra 2025/26.
.\˙ MarketWire
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After inspecting Novo's Clayton facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality control lapses, according to a Form 483 seen by Fierce Pharma.
Specifically, the two-observation report suggested Novo failed to thoroughly investigate unexplained batch discrepancies and dropped the ball when it comes to microbial controls.
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As for what those "discrepancies" were, the FDA said Novo on at least three separate occasions identified "objectionable organisms" during in-process testing of intermediate semaglutide.
In terms of controls, microbial limits "have not been established for in-process API material," in which microbes were discovered during the recovery phase, the FDA went on to say.
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Novo-rival sagsøger forskellige klinikker for salg af falsk diabetesmiddel https://www.proinvestor.com/investornyt/1051934/novo-rival-sagsoger-forskellige-klinikker-for-salg-af-falsk-diabetesmiddel
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@Stockwatch1 Kilde til 08:31 og 08:32?
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Regner med, det er dette https://www.fiercepharma.com/pharma/inside-form-483-novo-nordisks-north-carolina-semaglutide-plant
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Ja, det er det link
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Hvordan hænger det så sammen med novo’s udtalelse igår ? - det kan jeg ikke rigtigt gennemskue.
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Når FDA kommer på inspektion kommer der altid anmærkninger. Det er helt normalt på alle lokationer. Så kan der være forskel på hvor alvorlige de er.
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Det er yderst sjældent at der ikke er anmærkninger.
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Bemærk det er lover 2 mdr siden FDA var på inspektion. Så de kan i teorien allerede være fuldt ud compliance
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Den ene af dem er noget så simpelt som de ikke har en specificeret proces for microbial limits. Den burde de kunne lave inden de skulle sende handlingsplanen til FDA
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Den anden er de ikke har udført en detaljeret root cause undersøgelse af en/nogle batches som afveg fra deres proces
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Så passér gade. Her er intet at se
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Her lidt mere om dagens aftale med Ypsomed https://finance.yahoo.com/news/rpt-3-ypsomed-signs-autoinjector-090801711.html
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