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Novo Nordisk

Novo Nordisk takes legal action against Hims & Hers to protect patients from unsafe, knock-off Wegovy® and Ozempic®

2026-02-09 12:59:38

  • Hims & Hers unlawfully mass markets unapproved versions of Novo Nordisk’s FDA-approved semaglutide medicines, deceiving patients and putting their health at risk
  • Novo Nordisk takes decisive legal action to stop Hims’ illegal conduct, protect public health, and defend the scientific innovations that deliver better health outcomes to Americans living with serious chronic diseases like obesity and diabetes
  • Novo Nordisk is asking the court to permanently ban Hims from selling unapproved, compounded drugs that infringe our patents, and is seeking to recover damages

Plainsboro, NJ, US and Bagsværd, Denmark, February 9, 2026 – Novo Nordisk announced today that it has filed a lawsuit against telehealth company Hims & Hers (“Hims”), for infringing US Patent 8,129,343 with Hims’ compounded semaglutide products for the US market. Hims has engaged in promotional campaigns that highlight its compounded semaglutide products, duping consumers and healthcare professionals as to the clinical benefits and safety of these unapproved drugs. This includes Hims’ recent launch, and two days later, abrupt discontinuance of its “Compounded GLP-1 Pill,” which came on the heels of Novo Nordisk’s introduction of the Wegovy® pill, the first and only FDA-approved GLP-1 pill for weight loss. Hims continues to unlawfully mass compound injectable versions, made with inauthentic API, and these knock-offs are putting patient health and wellbeing at risk.

“Throughout Novo Nordisk’s 103-year-long history, patient safety has always been our top priority. Hims & Hers is mass marketing unapproved knock-off versions of Wegovy® and Ozempic® that evade the FDA’s gold standard review process – that’s dangerous and deceptive to patients, and undermines the scientific innovation and regulatory rigor in place to ensure these treatments are safe and effective,” said John F. Kuckelman, senior vice president, Group General Counsel, Global Legal, IP and Security. “We’ve taken legal action to protect the American public and our intellectual property and will continue to work with regulators, law enforcement, and other key stakeholders to ensure patients have access to FDA approved safe and effective medicines.”

Mass marketing by Hims and compounding pharmacies has flooded the market with knock-off Wegovy® and Ozempic®. Compounded semaglutide products may contain dangerous impurities or incorrect amounts of active ingredients, which can result in life-threatening immune responses, hospitalization, severe drug-drug interactions, and overdoses. According to Novo Nordisk’s testing, injectable semaglutide drugs compounded by pharmacies were found to contain impurities of up to 86%, with compounded oral semaglutide drugs containing impurities as high as 75%. Even in small quantities, such impurities can negatively impact the safety and efficacy of a drug product, including unwanted immune responses like anaphylactic shock.

As the FDA explained just last Friday, compounded GLP-1 drugs mass-marketed by Hims and other compounding pharmacies are “drugs for which the FDA cannot verify quality, safety, or efficacy.” Respected organizations and experts in the medical community, such as the American Medical Association, the American Diabetes Association (ADA), and the Endocrine Society, have voiced similar concerns about knock-off GLP-1 drugs and the risk they pose to patients. The ADA recommends against using these knock-offs due to uncertainty about their content, safety, quality, and effectiveness.

Today’s action builds on Novo Nordisk’s multi-year efforts to safeguard patients from unsafe compounded products, including other legal actions and educational campaigns like “Check Before You Inject” and “Choose The Real Thing” aimed at raising awareness about the risks of unapproved knock-off drugs made with foreign inauthentic active pharmaceutical ingredients that can pose significant risks to patient safety. For more information about these efforts to protect patients, visit [ semaglutide.com ]

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Får håpe det går bedre her enn Eli Lilly vs Mochi (uten at jeg har sammenlignet søksmålene )

Altså, problemet til LLY nå er at de er “first mover” med trippelagonist, og det er ikke gitt at komboen / balansen de laget mellom glp1/gip/glukagon-agonister i retatrutide er optimal. Snarere vil det nesten være rart om de traff optimalt på første forsøk. Kan være Novo har gjort grundig research på produktet. Ryktene skal faktisk ha det til at Novo snuste litt på en trippelagonist så tidlig som 2010, men konservative som de var (og er) slo de det fra seg pga antatt for høy bivirkningsbyrde.

Btw, syntes de Mazdutide-tallene så rare ut, og det var de.

Tallet som er brukt på 48 uker og som er kilda fra fase III’en GLORY-1 er egentlig fra 60 uker og fra GLORY-2, hvor høyere doser ble testet.

Men for all del, jeg tror UBT251 fort kan være en reta-konkurrent. Spennende :smiley:

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Sikkert bommet på navnet i kilden, men fant tilsvarende tall på 48 uker med samme dosering som i tabell, dog mye lavere n (n=60) (stemmer at glory-1 kun var 6mg)

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Egentlig veldig interessant dette:

Reta som er 3 agonister (GLP1/GIP/Glukagon, hvor fordeling er ca. 3:2:1) = tolererbarhet er rævva

Tirze er 2 (GLP1/GIP men virker ganske sterkt mot begge ) tolererbarhet er ganske grei

Sema er 1 (kun glp1) men tolererbarhet er ikke noe bedre enn tirzepatide, snarere motsatt

Mazdutide er GLP1/Glukagon i (etter minnet) 3:1 forhold = tolererbarhet er fin. I Kina that is

Pemvidutide er GLP1/Glukagon i 1:1 = tolererbarhet er tilsynelatende krute god.

Survodutide er GLP1/Glukagon i 8:1 = tolererbarhet skal visstnok være rævva (vi får vente å se på dataene før vi konkluderer helt og fullt)

For meg virker det som jo tyngre glp1 er vektet som mål, jo værre blir tolererbarhet?

Eller er greia at man ikke kan skyte på mer enn 2 mål samtidig uten at kroppen sier “hei dette blir litt vel mye ass”?

Edit: GCG(R) = GluCaGon(Receptor)

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Offtopic, men er flere som har fått problemer med magen i møte med GGG

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Snakker om sola del 2:

https://clinicaltrials.gov/study/NCT07395687

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Du vet du har innlisensiert en drug fra Kina når inkluderingskriteriene:

Inclusion Criteria:

Male or female (sex at birth).

For Part C: Japanese, Chinese or non-Asian participants (all self-reported):
    For Japanese participants: both parents of Japanese descent.
    For Chinese participants: both parents of Chinese descent.
    For non-Asian participants: both parents of non-Asian descent (non-Asian is defined as of countries outside of Asia).

PS: Denne trialen går altså i USA og Canada

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Så også den, vil det si at Indere (og alle andre fra Asia) i USA og Canada ikke får delta? :joy:

Så det også ble kommentert ang BMI kriteriene

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Synes han gjør god figur her også. En fin oppsummering av siste tids hendelser og litt hva man kan vente seg fremover

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Han gjør en god figur, men jeg skulle aller helst ønske at James Price var CEO.

Hvem er det? :sweat_smile:

Det er han passe røslige storebroren i Munter Mat (på norsk), ev. “Spise med Price” på dansk. Er ungene til han karen som jeg tror litt var den danske versjonen av Ingrid Espelid Hovig.

Han blir bare større og større for hver sesong, og virker bare helt sykt trivelig.

Litt dårlig impulskontroll på skrivinga. Skulle være morsom vettu.

Finnes selvfølgelig ikke kvalifisert for å være CEO i Novo

Har sett intervjuet nå, må si at MD er flink.

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Mer data

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Siden MD i intervjuet med Fox snakker litt om tingene sema kan som ikke tirze kan, så kan det jo være greit å titte litt på LLY trialene som er planlagt, kjøres, og rekrutterer akkurat nå:

Overvekt og kneatrose, overvekt og søvnapné, overvekt og urinveislekkasje osv…

Hadde ikke blitt overrasket om jeg nederst fant “overvekt og fotsopp” lizm

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Kan ikke annet enn å bli fasinert av denne medikamentet

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“ 21 minutter siden

Nye receptal fra Novo Nordisk er landet

Fredag er der landet friske recepttal for Novo Nordisks Wegovypille i USA.

I sidste uge, uge seks, lyder tallet på 38.423.

Det skriver Marketwire på baggrund af data fra Symphony Health Solutions via Bloomberg, som er baseret på forsikringsdækkede patienter.

Ugen forinden lød tallet på 29.347.”

Sakset fra Følg markedet live - det sker der nu | Nyheder | Video | Euroinvestor

Pænt stigning alligevel spændende og se hvor det ender.

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Akkurat lært meg å stave amycretin, nå må jeg lære zenagamtide

https://clinicaltrials.gov/study/NCT07400107

En trippelG :boxing_glove: også:

https://clinicaltrials.gov/study/NCT07415954

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Novo Nordisk A/S: The European Commission approves more effective dose of injectable Wegovy® for adults with obesity; clinical study showed people lost about 21% of their body weight on average

2026-02-17 14:58:25

  • The European Commission has granted final approval of a higher 7.2 mg maintenance dose of Wegovy® (semaglutide) for adults who may need extra help losing weight. It is now approved in all 27 countries in the European Union
  • In a study with 1,407 people, lasting about 1½ years, those on the higher dose lost, on average, about one‑fifth of their body weight.
  • Wegovy is now approved in the EU as a once‑weekly injection in six doses to help with weight management, used together with healthy eating and increased physical activity.

Bagsværd, Denmark, 17 February 2026 – The European Commission has approved a new 7.2 mg once‑weekly maintenance dose of Wegovy® (semaglutide injection) for adults living with obesity. This gives doctors another option to help adults who need more weight loss after being on the 2.4 mg dose. The approval is based on a positive opinion from the European Medicines Agency’s scientific committee (CHMP) on 12 December 2025.

The approval means that doctors in the EU may now prescribe the 7.2 mg dosage as three 2.4 mg injections, to be taken in one sitting, still once a week. Novo Nordisk has applied for approval of a 7.2 mg single-dose pen in the EU, and if approved, it could be available this year. This means that in the European Union (EU), adults with obesity may now step directly from Wegovy® 2.4 mg (for at least four weeks) up to 7.2 mg if they need greater weight loss while preserving muscle function.

Wegovy® 7.2 mg is already approved and available in the UK, and regulatory applications are pending with the US Food and Drug Administration (FDA) and several other countries.

What did the study show?
In the two clinical studies, STEP UP (1,407 participants) and STEP UP T2D (512 participants), adults with obesity, without and with type 2 diabetes, respectively, who took the 7.2 mg dose once a week, plus lifestyle changes, lost considerably more weight than people on placebo.

On average, participants with obesity, without diabetes, taking Wegovy® 7.2 mg had these results:

  • 21% body weight loss for those on Wegovy® 7.2 mg when everyone took the medicine as planned, compared to about 2% weight loss for those taking placebo.
  • About 1 in 3 people lost 25% or more of their body weight.
  • Body composition improved with the majority (84%) of weight loss with Wegovy® 7.2 mg coming from fat mass, with tests showing preserved muscle functioning.
  • The most common side effects were nausea, diarrhoea, vomiting (24.8%) and dysaesthesia (22-9%). These events were usually mild to moderate and transient.

“This approval is another important step in helping people living with obesity reach very significant weight loss,” said Emil Kongshøj Larsen, executive vice president, International Operations, Novo Nordisk. “The new dose gives healthcare professionals even more flexibility to tailor treatment and help people with obesity achieve their weight loss and health goals.”

Wegovy® injectable is now available in 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and now 7.2 mg doses throughout the EU. Wegovy® pill is available in the US and is pending approval in the EU.

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