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Was in den USA noch beantragt werden muss...
Novo Nordisk Eyes Approval for Higher-Dose TreatmentNovo Nordisk A/S
(NVO)
reportedly said on Tuesday that it intends to seek US regulatory approval for a high-dose version of its weight-loss injection Wegovy (semaglutide), another effort to counter Eli Lilly and Co.
(LLY)High-dose Wegovy offers the same weight-loss potential as Lilly's Zepbound, giving patients another option, Lange told Bloomberg in an interview.
"Obviously, our competitors have optimized the dosing," Lange said. "Now with high-dose Wegovy, we've done the same."
benzinga.com/news/fda/25/09/47692734/wegovys-next-step-novo-nordisk-eyes-approval-for-higher-dose-treatment
ist bereits in der EU beantragt.....
Novo Nordisk A/S: New Wegovy® dose submitted to European Medicines Agency for approval, with 1 in 3 trial participants achieving 25% or more weight lossBagsværd, Denmark, 8 July 2025 – Novo Nordisk today announced the submission of an application to the European Medicines Agency (EMA) for approval of a new, higher dose of its obesity treatment, Wegovy® (subcutaneous semaglutide 7.2 mg). This marks another significant milestone in the company’s goal to provide a broad portfolio of innovative and person-centric solutions to support people living with obesity, as part of their journey towards better health.
In the STEP UP trial, the new dose of Wegovy® (semaglutide 7.2 mg) demonstrated a substantial average weight loss of 21% in people with obesity, with a third of participants losing 25% or more of their body weight compared with placebo.
firstwordpharma.com/story/5979623
heut einen Tritt in den Hintern bekommen.
Hims & Hers Health Inc. stock is trading lower on Tuesday. The U.S. Food and Drug Administration (FDA) issued a warning letter to Hims & Hers Health, dated Sept. 9, addressed to the company’s CEO, Andrew Dudum.
In a warning letter, the FDA said the company's website promotes its semaglutide offerings with claims that imply equivalence to FDA-approved drugs, which the agency says is false and deceptive under federal law.
Compounded drugs are not subject to FDA approval, and these claims violate sections 502(a) and 502(bb) of the Federal Food, Drug and Cosmetic Act (FDCA), rendering them misbranded.
The agency further noted that introducing or distributing misbranded products across state lines is prohibited under section 301(a) of the FDCA.
Hims & Hers has been instructed to respond within 15 working days of receiving the letter. The company must outline the corrective steps it has taken, share supporting documents, and explain how it plans to prevent similar violations in the future.
benzinga.com/news/fda/25/09/47698948/hims-hers-scrutinized-for-marketing-its-product-as-similar-to-ozempic-wegovy
Ja, ja, ja, jetzt wird wieder in die Hände gespuckt, wir steigern das Bruttosozialprodukt.
Wegovy & Co dürften Sterberaten in Industrieländern senken
https://www.moneycab.com/international/...n-industrielaendern-senken/
Lilly hat sein orales Medikament mit dem viel schwächeren Rybelsus verglichen.
Wenn das orale Wegovy mit 25 mg auf den Markt kommt können sie gerne nochmal eine Studie machen. Absolute Manipulation von Lilly die aber von den meißten Marktteilnehmern durchschaut wurde. Siehe Kurse.
But it’s less clear how Eli Lilly’s pill compares to higher doses of oral semaglutide, especially in patients who are overweight or have obesity without diabetes. Novo Nordisk expects U.S. regulators to approve a higher 25-milligram dose of its pill for the treatment of obesity by the end of the year, and has also studied a 50-milligram dose of the drug in a phase three trial.
Weintraub said comparing the 36-milligram dose of Eli Lilly’s pill to oral semaglutide at a lower dose than what may be approved in the future “is short-changing semaglutide.” He added that patients with diabetes typically lose less weight than those without the condition, so the closer to 15% weight loss that oral semaglutide has shown in people with obesity is “certainly not expected” in a study on Type 2 diabetes patients.
Because the trial showed Eli Lilly’s pill was better at reducing blood sugar and weight only when compared to specific lower doses of oral semaglutide, “there are several orders that kind of slow the roll a little bit as we look at the results and get kind of excited,” said Dr. Jaime Almandoz, medical director of the Weight Wellness Program at UT Southwestern Medical Center.
https://www.cnbc.com/2025/09/17/...rdisk-drug-in-diabetes-trial-.html
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| Wertung | Antworten | Thema | Verfasser | letzter Verfasser | letzter Beitrag | |
| 16 | 5.840 | Novo-Nordisk - Insulinpräparate | elNacho | Homeopath | 17.03.26 22:01 | |
| 30 | Das 1. Medikament, welches Alzheimer verbessert | Leronlimab | uranfakts | 22.09.22 21:26 | ||
| 15 | Dividenden-Giganten | dipling | Lalapo | 10.12.16 11:08 | ||
| Thema Diabetis-Insulien | SonNegre | 23.02.15 17:50 |