NOVO — Juni 2025
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Let’s break down what just happened and what it means.
The OFA had claimed the FDA did not follow the law when it removed Ozempic and Wegovy from the official shortage list back in February. They argued that the delisting was actually a rule and should have gone through public notice and comment. They also claimed the FDA did not properly weigh the data or consider how much demand is still being met by compounders.
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The judge rejected all of it.
The court said the FDA did not make a sweeping new rule. Instead, it made a case by case decision based on real data from Novo Nordisk and internal review. That kind of decision does not require public input, and the judge made it clear the FDA is allowed to work this way.
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The OFA also pointed to a quote from Novo’s CEO in a media interview, where he said demand still exceeds supply. They tried to use that to prove shortages were still happening. But the court was not buying it. The judge said the FDA had already asked Novo about that quote, and Novo clarified it was referring to the global market, not the US market, and not just to semaglutide
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The court also dismissed the OFA’s evidence from screenshots of pharmacy websites and consumer surveys as untrustworthy, outdated, or flawed. The judge emphasized the FDA was right to rely more on structured reporting from Novo than on anecdotal data from Hims and Hers or unverified claims from compounders.
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In what might be the most biting part of the whole thing, the court suggested the OFA repeatedly misread or misrepresented the facts. There is even a line where the judge said their consistent and pervasive pattern of similar mistakes made it hard to keep assuming it was just an accident.
That is not the kind of thing you want to hear from a federal judge.
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Kilde: On the pen.
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Mens Novo leder efter ny topchef: Opgørelse viser lønniveau på 150 mio. kr. i udlandet https://proinvestor.com/investornyt/1330416/mens-novo-leder-efter-ny-topchef-opgorelse-viser-lonniveau-pa-150-mio-kr-i-udlandet
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Urolige tider på verdensplan gør mange nervøse, men hvor høj er risikoen egentlig for investorerne? Hør også om den aktuelle nedtur i Zealand Pharma, Trumps effekt på Ørsted og Vestas samt om de nye data, der er på vej fra Novo Nordisk i afsnit 279 af Investeringspodcasten https://proinvestor.com/boards/126828
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Novo får ret i Texas: Kopister må ikke mere fremstille Wegovy og Ozempic https://proinvestor.com/investornyt/1330881/novo-far-ret-i-texas-kopister-ma-ikke-mere-fremstille-wegovy-og-ozempic
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USA har lukket = Novo stiger
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Ugekommentar om Zealand Pharma og Novo Nordisk: https://proinvestor.com/boards/126847/
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Novo Nordisk: Nu må kuppet føres igennem https://proinvestor.com/investornyt/1331119/novo-nordisk-nu-ma-kuppet-fores-igennem
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Novo Nordisk: Består de eksamen i Chicago? https://proinvestor.com/boards/126858
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Spotlight On: What to watch at ADA 2025 https://firstwordpharma.com/story/5973976
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Rygter flere steder om at Britt Melbye (ambu)
er i spil som ny CEO hos Novo -
Tror eller ikke hun er tung ok - de skal have interational profil denne gang
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