As demand skyrockets for GLP-1 drugs that can trigger significant weight loss, unauthorized versions of the treatments have started to fill pharmacies. In late May, the FDA warned of illegal knockoffs of Novo Nordisk’s Ozempic and Wegovy. Now, five weeks later, the Danish company has filed its second wave of lawsuits against pharmacies in the U.S. that are producing the copycats. Thursday, in federal courts in Florida and Tennessee, the company accused four companies of making compounded versions of its products that are not approved by the FDA. “Testing new drugs and obtaining the regularly acquired regulatory approval to sell them are time-consuming and very costly,” Novo said in its complaints. “Ignoring drug-approval requirements provides defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Worse, it puts patients at risk by exposing them to drugs that have not been shown to be safe or effective.” The defendants are compounding ...
Dive Brief Novo Nordisk said it is in exclusive talks to buy French medical device company Biocorp. Novo Nordisk will buy out Biocorp’s main shareholder, Bio Jag, for 35 euros per share, and then make a tender offer for any outstanding shares at the same price, the companies said Monday. The offer would value all of the company at 154 million euros ($165 million). Denmark-based Novo Nordisk, which makes pharmaceutical products and insulin pens, has been collaborating with Biocorp since 2021 on a smart pen cap that tracks information on dose, date and time of injection. Dive Insight Novo Nordisk wants to innovate faster and develop new connected devices, and expects that Biocorp would complement its internal efforts, said Marianne Ølholm, Novo Nordisk’s senior vice president of devices and delivery solutions. Novo Nordisk will work with Biocorp to invest in new devices and drug delivery solutions for people with chronic ...
In the rush to supply prescriptions of Novo Nordisk’s popular diabetes and weight loss meds, some pharmacies are making unauthorized versions of Ozempic and Wegovy, the FDA warned on Tuesday. Some compounding pharmacies, which are permitted to make drugs during times of shortage, are using unauthorized versions of semaglutide—the key active ingredient in the GLP-1 drugs. Compounding pharmacies are currently allowed to make Ozempic and Wegovy because they are in short supply. But they must use approved ingredients, the FDA points out. The agency has received adverse event reports after patients have used compounded semaglutide. In some cases, compounders may be using salt forms of semaglutide, called semaglutide sodium or semaglutide acetate, which have not been proven to be safe or effective. The FDA asks users of Ozempic and Wegovy to get a prescription from a licensed provider and only obtain drugs from state-licensed pharmacies or outsourcing facilities registered with ...
An oral drug made by Pfizer causes a similar amount of weight loss as rival Novo Nordisk’s blockbuster injection Ozempic, according to a peer-reviewed study of phase 2 clinical trial results released Monday. The results were presented at a medical conference late last year, and did not compare Pfizer’s drug with Ozempic or other weight loss medications. JAMA Network only now is releasing a peer-reviewed study. Pfizer’s trial followed 411 adults with Type 2 diabetes who either took the company’s pill, danuglipron, twice a day or a placebo. Body weight was “statistically significantly reduced” after patients took either 120-milligram or 80-milligram versions of danuglipron for 16 weeks, the study found. Patients who took a 120-milligram version lost around 10 pounds on average over that time period, the study found. Pfizer’s drug could offer an advantage as an oral treatment option rather than a frequent injection. The study results also suggest ...
Just last week, GLP-1 giant Novo Nordisk promised a supply boost of its in-demand obesity med Wegovy after lining up a second contract manufacturer. Now, though, the company is “temporarily” reducing U.S. supply of lower dosage strengths to “safeguard continuity of care,” the company said in a statement. The company sees a “short-term need” to cut back on starter doses of the drug,” CEO Lars Fruergaard Jørgensen said on the company’s first-quarter earnings call Thursday. The CEO added that manufacturing is “running well” and that the reduction will play out over a “limited period.” “We’re not out of the market with the low dose strengths. We’re just reducing supply,” Jørgensen said, noting that patients will still be able to get the product, just possibly with a longer wait time. Meanwhile, the Danish drugmaker posted huge obesity revenue gains of 124% versus last year’s first quarter, rising to 7.8 billion ...
The stakes are getting even higher for the fight between Eli Lilly and Novo Nordisk for supremacy in the multibillion-dollar obesity market. Lilly on Friday quietly registered a new phase 3b trial on clinicaltrials.gov. The study, coded SURMOUNT-5, will pit Lilly’s Mounjaro against Novo’s Wegovy in patients with obesity or overweight with weight-related health conditions. The trial aims to enroll 700 participants from 61 sites in the U.S., Canada, South America and several European countries, according to the post. The study is currently expected to officially start next Friday and last for about 78 weeks, with an estimated primary completion date in February 2025. On the study’s primary endpoint, investigators will compare the percentage weight changes between the two drugs by week 72 from baseline. However, it’s not immediately clear whether Lilly is designing SURMOUNT-5 as a superiority study to show Mounjaro is better than Wegovy or just to show ...
Insulin resistance is becoming more prevalent, affecting 15.5% to 46.5% of the world’s population Novo Nordisk and Dewpoint Therapeutics have entered into a research and development partnership aimed at identifying drug candidates to treat insulin resistance and diabetic complications. A key driver of type 2 diabetes and metabolic syndrome, insulin resistance occurs when the body has an impaired response to insulin, resulting in elevated levels of glucose in the blood. The condition is rising in prevalence globally, affecting 15.5% to 46.5% of the world’s population. The collaboration will see the partners use Dewpoint’s discovery and AI technology platform to identify modulators of biomolecular condensates – membraneless organelles comprising proteins and RNA – that may be involved in insulin resistance and insulin sensitivity. The dysregulation of these condensates has been observed in many diseases, including diabetes, which is why Dewpoint believes that using its platform to develop ...
Novo Nordisk will reduce the list price of four legacy insulin brands, including NovoLog and NovoLog Mix 70/30, by 75%. Novo Nordisk has announced plans to reduce the US wholesale acquisition cost (WAC), also known as the list price, of several pre-filled insulin pens and vials by up to 75% for people living with type 1 and type 2 diabetes. Set to come into effect from 1 January 2024, these changes will be applicable for products including pre-filled pens and vials of basal (long-acting), bolus (short-acting) and pre-mix insulins, Levemir, Novolin, NovoLog and NovoLog Mix 70/30 in specific. Novo Nordisk Market Access & Public Affairs senior vice-president Steve Albers said: “We have been working to develop a sustainable path forward that balances patient affordability, market dynamics, and evolving policy changes. “Novo Nordisk remains committed to ensuring patients living with diabetes can afford our insulins, a responsibility we take seriously.” The company will reduce the ...
New results from a Phase IIIa study have demonstrated that Novo Nordisk’s weight loss drug semaglutide improved physical function and wellbeing among people with obesity. The STEP 1 trial demonstrated benefits for people with obesity treated with semaglutide 2.4mg ‘beyond weight loss’, Novo said in a statement. Over a 68-week period, treatment with once-weekly semaglutide 2.4mg was associated with greater improvements for all weight- and health-related quality of life scores in people with obesity or overweight in comparison to placebo. This included improved wellbeing, with 43.8% of patients treated with Novo’s drug achieving a clinically meaningful improvement in total weight-related quality of life score at week 68. On top of that, 51.2% of participants treated with semaglutide 2.4mg in the trial had an increased weight-related physical function score, reflecting improvements in the ability to perform daily activities. In addition, patients treated with semaglutide 2.4mg ‘simultaneously’ experienced significant weight loss of ...
Novo Nordisk’s Sogroya (somapacitan) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use – moving closer towards approval in the EU. The CHMP has recommended marketing authorisation for Sogroya for the treatment of adults with growth hormone deficiency (AGHD). The recommendation is based on results from the Phase III REAL 1 clinical trial programme, which investigated the efficacy and safety of Sogroya in AGHD. “We are very pleased with the positive opinion for once-weekly Sogroya as we are committed to continuously developing innovative and efficient medicines for people living with growth hormone deficiency,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. “We are confident that Sogroya will make management of this serious chronic disease easier and help improve the quality of life for more people living with growth hormone deficiency,” he added. Sogroya is a ...
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