NOVO — Juni 2025
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- kommunikation, som skaber spekulationer. Og når de ikke vil forklare deres investorer, hvorfor de ikke ønskede Canadisk patent, så står det bare tilbage som en, i bedste fald, mærkelig beslutning. Eller måske vitterlig en forglemmelse, som den Canadiske konkurrent omtaler det som.
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- Novo trænger virkelig til en ny kommunikationsstrategi. De burde sætte dagsordenen og holde på narrativet. I stedet sætter konkurrenter, spekulanter og medierne sig på det og vi investorer betaler prisen. Jeg synes, det er arrogant over for markedet og vi investorer.
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Godmorgen
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The FDA Wins. The OFA Loses. And Semaglutide Is Off the Shortage List for Good
On The Pen
Jun 18READ IN APP
On Friday, June 13, a federal judge officially sided with the FDA and Novo Nordisk in the lawsuit brought by the Outsourcing Facilities Association over compounded semaglutide. The ruling was sealed at the time but was just unsealed today, Tuesday, June 17.
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In simple terms, the OFA lost. The FDA won. And unless this is appealed and reversed, which is unlikely, mass-compounded 503B semaglutide is staying off the drug shortage list for good.
This means 503B pharmacies can no longer legally compound semaglutide using the shortage exemption. That door is closed. What remains are 503A custom doses and formulations which have flooded the market in the wake of the ending of essential copies
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If this feels familiar, it is because it is. The judge’s reasoning in this case closely tracks his ruling in the tirzepatide lawsuit earlier this year. That case involved Eli Lilly and compounded versions of Zepbound and Mounjaro. In both cases, Judge Pittman concluded that the FDA had the authority to delist the drugs without going through public comment, and that their decision was not arbitrary or capricious.
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The court again showed deference to the FDA’s judgment and the underlying data provided by the manufacturer
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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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