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Home  /   Forum   /   NOVO-NORDISK AS   /   Forum Novo Nordisk geopend

Aandeel NOVO-NORDISK AS CHX:NOVOB_C.DXE3, DK0062498333

Laatste koers (dkk) Verschil Volume
761,600   -7,300   (-0,95%) Dagrange 761,000 - 776,400 200.117   Gem. (3M) 1,2M

Forum Novo Nordisk geopend

Volgen
183 Posts
Pagina: «« 1 2 3 4 5 6 ... 10 »» | Laatste | Omlaag ↓
  2. forum rang 10 DeZwarteRidder 13 september 2023 12:25
    quote:

    Polleke schreef op 13 september 2023 12:24:

    Ben niet bekend met een split van aandelen. Heb 10 stuks in mijn portefeuille.
    Tegen afgifte van één aandeel ontvangt u 2 aandelen NOVO NORDISK A/S -B (DK0062498333).
    Ex-coupondatum: 13-09-2023
    Betaaldatum: 13-09-2023
    Wat moet ik doen?
    Helemaal niks!!!!
  11. forum rang 8 GakGak 21 september 2023 17:10
    ai,

    U.S. FDA found lapses at Novo's main U.S. factory in May 2022 -report
    NOVO B

    642,30 -20,30 -3,06%
    (Adds detail on factory in paragraph 3, company comment in 7, FDA response in 8-10)

    By Maggie Fick

    LONDON, Sept 21 (Reuters) - U.S. drug regulators issued a report detailing quality control lapses at Novo Nordisk's main factory in North America as early as May last year, according to the report obtained by Reuters via a Freedom of Information Act request.

    The inspection by the U.S. Food and Drug Administration (FDA) was at Novo's facility in Clayton, North Carolina, which the company says produces the active pharmaceutical ingredient (API), semaglutide.

    The site makes oral semaglutide for Novo's diabetes drug Rybelsus, a spokesperson told Bloomberg on Thursday. A spokesperson declined to comment when asked by Reuters to confirm this.
    Semaglutide is also used in Novo's hugely popular weight-loss drug Wegovy and type 2 diabetes drug Ozempic, which are injections.
    There is no evidence that compliance failures flagged in the report known as a Form 483 resulted in harm to users of Wegovy and Ozempic. A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable".

    The issues were with the factory's control systems to prevent microbial contamination, the same as those raised in the more recent inspection this July, which was first reported by financial news agency MarketWire and pushed Novo's shares down 3%.
    Novo declined to comment on the May 2022 report, which was first reported by Reuters, but repeated its statement on Monday in response to the FDA's report from its July inspection that the Clayton site was "running and producing for the market".

    The FDA said in a statement to Reuters that FDA inspectors, as part of the agency's normal operations, conducted "pre-approval and routine inspections" of the facility and issued Form 483s following those inspections.

    "The company responded to these observations with information describing corrective actions," the FDA's statement read.
    "At this time, based on the FDA’s inspections and the company’s responses to the inspectional observations, the FDA does not have information that suggests ongoing compliance issues that raise concerns about the quality of drug products manufactured at the site."

    One industry expert, who spoke on condition of anonymity due to the sensitivity of the matter, said similar issues at two inspections some time apart could expose the site to increased scrutiny from the FDA going forward.
    The report from the May 2022 inspection shows that FDA officials found the factory had failed to include one type of bacteria, abbreviated as B. cepacia, on its list of "objectionable organisms".
    Two of the factory's laboratory investigations, in 2020 and 2021, found drug product samples containing this particular bacteria, the report read.
    The report included a second manufacturing lapse: "Failure to clean equipment at appropriate intervals" to prevent build-up of microorganisms on equipment. The report noted that the equipment in question was used for "continuous production" of batches of API.

    When inspectors returned to the facility in July, they found that although the site was identifying objectionable organisms during testing of batches of semaglutide API, it had failed to thoroughly identify the cause of the bacteria present in these batches.
    Analysts at Barclays and Jefferies said in notes this week that, although investors may be concerned by news of potential manufacturing issues, they saw minimal impact on Novo's production of semaglutide.
    Steven Lynn, a former head of the FDA's Office of Manufacturing and Product Quality who is now a regulatory compliance consultant, said that while the subject matter in the two inspections is the same, it is not fair to say that the recent inspection shows the factory had failed to correct the lapses that inspectors found last year.

    "It looks like (the factory) amped up their objectionable organism list, but now they aren’t adequately investigating issues when they identify one of the objectionable organisms," he said.
    Other manufacturing experts say the FDA plays close attention to whether lapses identified in previous agency inspections have been fixed as a metric for whether a company is adhering closely to good manufacturing principles.

    (Reporting by Maggie Fick Editing by Josephine Mason and Mark Potter)

    ((maggie.fick@thomsonreuters.com; +44 7890 916706;))
  17. forum rang 8 GakGak 28 september 2023 10:50
    quote:

    DeZwarteRidder schreef op 20 september 2023 13:17:

    Eli Lilly is bezig met een concurrerend middel tegen obesitas en waarschijnlijk komen er nog veel meer concurrenten bij.
    .
    Maak je niet dik !
    .
    NOVO B

    DKK
    652,30
    +4,80
    (+0,74%)...ligt stevig in de markt
    .
    SG Novo-Nordisk B Factor (Multi) Long LEV 7

    48,40
    +1,19
    (+2,52%)
  18. forum rang 5 Altijd 2 oktober 2023 13:34
    Goedemiddag allen, tijdens het hardlopen kom ik vaak dezelfde man tegen, een wandelaar. Die na cororna behoorlijk gezet is geraakt, ondanks al zijn wandelkilometers. We bespraken de situatie en ben me in afslankmogelijkheden gaan verdiepen. Om in elk geval mezelf te helpen heb ik erg veel Novo Nordisk ingeslagen, zowel aandelen als geschreven puts. Weegt zwaar op de portefeuille. Ik denk ook dat Novo Nordisk nog veel groter gaat worden, en gezien de behaalde marge lijkt mij dit aandeel een no-brainer. Meestal wordt het na die conclusie gevaarlijk, dus we gaan het zien!
  20. NBosch 2 oktober 2023 18:17
    quote:

    yanmik schreef op 12 september 2023 10:09:

    [...]

    Ik herhaal mijn vraag van 1 week geleden:
    Koop je dan NVO in NYSE of NOVO-B in Kopenhagen ?
    Vandaag kopen of wachten tot na de split ?
    Ik heb voor NYSE gekozen. Ik had al een dollar rekening bij mijn broker. Ik neem aan dat als je ze in Kopenhagen koopt een kronen rekening krijgt bij je broker. Heb dus om administratieve redenen gekozen. Verder loop je natuurlijk valuta risico. Enerzijds tegen de dollar anderzijds tegen de Deense kroon.
183 Posts
Pagina: «« 1 2 3 4 5 6 ... 10 »» | Laatste |Omhoog ↑

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