NOVO — Juni 2025
-
Lilly makes all Zepbound doses available through its direct pay programme https://firstwordpharma.com/story/5973052
-
Jyske Bank: Novo Nordisk – Kan ADA vende stemningen omkring CagriSema? https://proinvestor.com/investornyt/1329887/jyske-bank-novo-nordisk-kan-ada-vende-stemningen-omkring-cagrisema
-
Har investorerne mistet appetitten på fedmeaktier? https://proinvestor.com/boards/126810
-
Lilly to acquire Verve Therapeutics to advance one-time treatments for people with high cardiovascular risk https://investor.lilly.com/news-releases/news-release-details/lilly-acquire-verve-therapeutics-advance-one-time-treatments Lilly IR
-
Tumpe "Der kan meget snart blive lagt told på importen af lægemidler i USA.
Det siger den amerikanske præsident, Donald Trump, tirsdag på vej tilbage fra G7-topmødet ifølge Reuters.
-
Vi kommer til lægemidlerne meget snart. Det kommer til at bringe alle selskaberne tilbage til USA, siger han.
-
Det kommer til at bringe de fleste af dem i hvert fald delvist tilbage, tilføjer han ifølge Reuters."
-
-
Jeg er ganske skuffet over Novo i sagen om det canadiske patent. I alle artikler jeg finder, er deres eneste svar, at det ikke skyldtes en forglemmelse, men at alle sådanne valg foretages efter grundige overvejelser. Ingen steder forsøger de at hjælpe folk med at forstå, hvorfor de så har valgt ikke at have patent i Canada. Når man selv skriver til dem og spørger, så er viden om deres patent strategi fortrolig. Og iøvrigt kommenterer de ikke på spekulationer. Men det er jo netop deres mangel på-
-
- 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.
-
- 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.
-
Godmorgen
-
"
Forwarded this email? Subscribe here for more
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.
-
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
-
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.
-
The court again showed deference to the FDA’s judgment and the underlying data provided by the manufacturer
-
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.
-
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.
-
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
-
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.
Hello! It looks like you're interested in this conversation, but you don't have an account yet.
Getting fed up of having to scroll through the same posts each visit? When you register for an account, you'll always come back to exactly where you were before, and choose to be notified of new replies (either via email, or push notification). You'll also be able to save bookmarks and upvote posts to show your appreciation to other community members.
With your input, this post could be even better 💗
Tilmeld Log ind