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Top related persons:
Clayton - 2 Maggie Fick - 2 Andrew Kelly - 1 Jefferies - 1 Steven Lynn - 1 Josephine Mason - 1 Mark Potter - 1 Jacob Gronholt - 1
Top related locs:
White Oak , Maryland U.S North America Clayton , North Carolina Novo Copenhagen Denmark Clayton
Top related orgs:
FDA - 2 REUTERS - 2 Novo Nordisk - 2 Thomson - 2 Food and Drug Administration - 1 U.S . Food - 1 Drug Administration - 1 Barclays - 1

Search resuls for: "MarketWire"


2 mentions found


☆ Exclusive: U.S. FDA found lapses at Novo's main U.S. factory in May 2022 -report
  + stars: | 2023-09-20 | by ( Maggie Fick | ) www.reuters.com   time to read: +4 min
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable". The FDA did not immediately respond to a request for comment on the report, but usually does not comment on inspections. 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". 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.
Persons: Andrew Kelly, Clayton, Jefferies, Steven Lynn, Maggie Fick, Josephine Mason, Mark Potter Organizations: Food and Drug Administration, FDA, REUTERS, Novo Nordisk, Reuters, U.S . Food, Drug Administration, Barclays, Manufacturing, Thomson Locations: White Oak , Maryland, U.S, North America, Clayton , North Carolina
☆ Novo Nordisk shares fall after media report about quality lapses at U.S. plant
  + stars: | 2023-09-18 | by ( ) www.reuters.com   time to read: +1 min
Flags are seen outside Novo Nordisk headquarters in Copenhagen, Denmark, February 5, 2020. REUTERS/Jacob Gronholt-Pedersen/File Photo Acquire Licensing RightsCompanies Novo Nordisk A/S FollowCOPENHAGEN, Sept 18 (Reuters) - Novo Nordisk's (NOVOb.CO) shares fell on Monday after financial news agency MarketWire reported that U.S. drug regulators had recently issued a report detailing quality control lapses at the group's Clayton, North Carolina plant, citing sources. Novo Nordisk declined to comment on the report, but said in an emailed statement that the site was "running and producing for the market". MarketWire did not specify when the FDA inspection occurred. According to the FDA, a Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable".
Persons: Jacob Gronholt, Pedersen, MarketWire, Clayton, Maggie Fick, Anna Ringstrom, Jan Harvey Organizations: Novo Nordisk, REUTERS, Reuters, FDA, Thomson Locations: Novo, Copenhagen, Denmark, Clayton, North Carolina
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