Latest news with #GLP-1s
The Hill
3 days ago
- Business
- The Hill
FDA's removal of Ozempic, Wegovy from drug shortage list upheld
A federal judge on Wednesday ruled that the Food and Drug Administration's (FDA) decision to remove popular GLP-1s from its drug shortage list, ending the sale of compounded versions of the drugs, was lawful and that the agency acted correctly. U.S. District Court Judge Mark Pittman found that the Outsourcing Facilities Association (OFA), an organization which represents compounding pharmacies, was wrong in its argument that the FDA's decision to remove GLP-1 drugs was 'arbitrary and capricious.' Earlier this year, the FDA officially moved semaglutide, including popular versions like Ozempic and Wegovy, off of its drug shortage list, signaling the end of the condition which permitted compounding pharmacies to sell compounded versions of the drug. The OFA had filed its lawsuit months before this, arguing the move to take GLP-1s off the shortage list was 'abruptly depriving patients of much needed treatment and artificially raising drug prices.' Their suit had initially been prompted by the removal of tirzepatide, marketed as Mounjaro and Zepbound, from the shortage list. The OFA had argued that Novo Nordisk, which manufacturers semaglutide, even acknowledged that compounded drugs satisfied 20 percent of the market, but Pittman noted that it seems they misread the record they were citing multiple times. 'In cases where such mistakes can be attributed to either an accidental misread or an intentional mischaracterization, the Court prefers to attribute them to accident rather than malice,' wrote Pittman. 'However, Plaintiffs' consistent and pervasive pattern of similar mistakes, in this case and OFA I, has made it increasingly difficult for the Court to assume they are the product of accident. Pittman took issue with some of the evidence presented by the plaintiffs, pointing to a 10-page chart that the plaintiffs created. It was not in the administrative record when the FDA considered its decision and thus it was not 'arbitrary' for the agency to not take the chart into consideration, the judge found. The plaintiffs also pointed to a report by the telehealth company Hims & Hers, which sold compounded GLP-1s when the branded versions were in shortage, that relied on a survey involving tirzepatide and semaglutide products. Pittman noted there was no way to verify how many people took part in the survey or what it defined as an 'inability to access.' Because the OFA didn't provide any new information, the court maintained it was not unreasonable for the FDA to give this survey 'less weight.' The Hill has reached out to the OFA for comment. The case was dismissed with prejudice, meaning this was a final judgment from Pittman. The OFA filed a notice of appeal on Wednesday in the U.S. District Court of Appeals for the Fifth Circuit.
Yahoo
3 days ago
- Business
- Yahoo
Omada Health releases new data on its GLP-1 companion program
Omada Health (OMDA) released new data demonstrating that Omada's GLP-1 companion program significantly improved persistence rates for GLP-1 medications. Evidence suggests that persistence on a GLP-1 is associated with greater weight loss. Omada's analysis found that those who persisted with their GLP-1 medication achieved weight loss results similar to what has been found in controlled research settings. Omada analyzed 1,124 members without diabetes who self-reported GLP-1 use to assess the impact of its Enhanced GLP-1 Care Track on medication persistence through 24 weeks. Self-reported medication initiation and persistence were confirmed using objective pharmacy claims data. Previous real-world studies have demonstrated a wide range in medication persistence rates at 12 weeks, 42% to 80%, and 24 weeks, 33% to 74%, after starting GLP-1s. In contrast, members included in this analysis of Omada's Enhanced GLP-1 Care Track demonstrated higher persistence rates-94% through 12 weeks and 84% through 24 weeks Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on OMDA: Disclaimer & DisclosureReport an Issue Omada Health Completes Successful Initial Public Offering
Time of India
3 days ago
- Health
- Time of India
Weight-loss surgery more effective than drugs in real world study
London: Bariatric surgeries led to about five-times more weight loss than weekly injections of popular GLP-1 drugs , according to data from a real-world comparison study presented on Tuesday at the American Society for Metabolic and Bariatric Surgery scientific meeting in Washington. "Clinical trials show weight loss between 15% to 21% for GLP-1s, but this study suggests that weight loss in the real world is considerably lower even for patients who have active prescriptions for an entire year," study leader Dr. Avery Brown of NYU Langone Health said in a statement. Researchers reviewed records of 38,545 patients who were prescribed injectable semaglutide or tirzepatide between 2018 and 2024 and 12,540 patients who underwent bariatric surgery during the same period. Everyone started the study with a body mass index of at least 35, which is considered severe obesity. Semaglutide is the main ingredient in Novo Nordisk 's Wegovy and Ozempic, while tirzepatide is the main ingredient in Eli Lilly 's Zepbound and Mounjaro. At three years after undergoing sleeve gastrectomy or gastric bypass or starting the drugs, patients who underwent surgery had lost on average 24% of their starting weight, compared to about 5% for similar patients who used the drugs for at least six months and about 7% for those who took them for a year. Brown noted that as many as 70% of GLP-1 patients may discontinue treatment within one year. "While both patient groups lose weight, metabolic and bariatric surgery is much more effective and durable," ASMBS President Dr. Ann M. Rogers, who was not involved in the study, said in a statement. "Those who get insufficient weight loss with GLP-1s or have challenges complying with treatment due to side effects or costs, should consider bariatric surgery as an option, or even in combination," she said. NEW BLOOD TEST MAY REDUCE LIVER TRANSPLANT FAILURES An experimental blood test can help surgeons catch and identify problems with newly transplanted livers at early stages, researchers say. It's not unusual for transplanted organs and recipients' nearby tissues to sustain damage during the transplantation process. Hints of problems will show up later in routine blood tests, but identifying the precise site of the damage often requires costly imaging studies and surgical biopsies, according to a report published on Tuesday in Nature Communications. The new test works by picking up DNA fragments left behind in the blood by dying cells. The chemical signatures on these DNA fragments can be used to identify the original cell type and where it came from, with precise detail, the researchers found. If you can determine which part of the liver is injured - for example, the bile ducts, or the blood vessels - "you could provide a more personalized treatment approach that leads to better care for the patient," study leader Dr. Alexander Kroemer of MedStar Georgetown University Hospital in Washington, DC said in a statement. In addition to being faster and less invasive than a traditional biopsy, the blood test is also potentially more accurate, because biopsies only sample a few spots in the liver and might miss the site of the problem, he added. Georgetown has filed patent applications on the technology, and the research team is seeking partners to commercialize the test. DIABETES PRECURSOR SHOWS UP ON MUSCLE ULTRASOUND Ultrasound exams of thigh or shoulder muscles can detect insulin resistance at its earliest stages, researchers reported in the Journal of Ultrasound in Medicine. "We perform a large number of shoulder ultrasounds and noticed that many patients' muscles appear unusually bright," study leader Dr. Steve Soliman of the University of Michigan said in a statement. His team discovered in earlier studies that most of these patients have type 2 diabetes. But some had bright muscles on ultrasound even with no signs of diabetes or prediabetes. Subsequently, upon short-term follow-up, these patients often also developed prediabetes or type 2 diabetes. To test the potential for noninvasive muscle ultrasound as a predictive tool for detecting the development of pre- or type 2 diabetes - potentially earlier than current methods - the researchers performed muscle ultrasounds on 25 patients who were also being evaluated for insulin resistance. Although muscle ultrasound could detect insulin resistance and impaired insulin sensitivity, in this small study the level of brightness was not directly correlated with the degree of the condition. The researchers are recruiting more participants to continue the analysis. The exact reason why muscle brightness on ultrasound might indicate insulin resistance is less clear than the finding that it does, the researchers said. "Clinicians increasingly use these point-of-care and handheld ultrasound devices, sometimes called 'the stethoscope of the future,' for rapid diagnosis of various conditions," Soliman said. "A medical assistant or clinician with little to no training could easily use this device on a patient's upper arm or thigh, as routinely as checking weight or blood pressure, and potentially flag patients as 'high risk' or 'low risk' for further testing."
Yahoo
4 days ago
- Business
- Yahoo
Supplement Company Veracity Secures $6 Million Raise as It Focuses on Metabolic Health
Medical grade supplement brand Veracity has secured a $6 million raise. The raise, which brings the brand's total funding to $14 million, was led by Maveron Ventures and co-led by Melitas Ventures. Previously known for its test-to-treatment hormonal health offerings, Veracity is using the fund to further pivot its business to metabolic health. More from WWD Tracy Anderson Introduces New Studio Concept in Santa Monica: Privé Iris Ventures Leads Multimillion-dollar Investment Into Fast-growing Wellness Platform Healf The Top Five Health and Wellness Trends in 2025, According to The Vitamin Shoppe '[This raise is] to support our continued involvement as the leader in non-drug, natural, safe metabolic health,' said founder and chief executive officer Allie Egan. She added that the raise will be invested in research and development of new products, which is more important than ever as a variety of brands are entering the metabolic health space following the rise of GLP-1s. To further compete in the space, the brand has also brought on a new chief science officer Giorgio Dell'Acqua, formerly the chief science officer at Nutrafol. According to Egan, the company opted to pivot its model after launching its Metabolism Ignite, $75, a GLP-1-boosting supplement featuring Metabolaid, green coffee bean extract and magnesium, in 2023. Over the course of the last two years, the brand has grown the business by 30-times, thanks primarily to this launch, as consumers are seeking additional metabolic health solutions. 'We developed that product because we were testing tens of thousands of people's hormones, and not only having access to their actual health data but seeing what their biggest problems were. They would tell us through our onboarding quiz what their biggest issues were. We said, 'Clearly there's a metabolic health issue here,'' Egan said. According to Egan, it took the brand one year to develop and when it launched, it far exceeded the team's expectations, ultimately leading to a significant pivot for the company. 'We decided based on that success this is really what the market is telling us it needs and wants for us and where we have a lot to offer,' she said. 'We really simplified our brand to say, instead of addressing everything within root cause medicine [for] hormone health, let's just focus on this metabolic piece and do it really well.' The brand has continued to see the impact of this, as it has grown 30 to 40 percent each month. Additionally, 90 percent of the brand's new customers are subscribing to products. As Egan plans to deepen the brand's commitment to metabolic health solutions, she is also hoping to change the narrative around the category with Veracity. 'Everything in the world of metabolic health, weight loss [and] weight management is so time bound, even the healthy stuff,' she said. 'Everything is 'Oh, just do this for this very small discrete amount of time.' The narrative that we want to help amplify is that metabolic health and weight management… are a long-term commitment.'
Yahoo
4 days ago
- Health
- Yahoo
Omada Health's Enhanced GLP-1 Care Track Demonstrates Increased Medication Persistence and Weight Loss Outcomes at 12 and 24 Weeks
New GLP-1 analysis reveals that by addressing real-world barriers to persistence, Omada's companion program can help sustain GLP-1 use, delivering on clinical trials' promises SAN FRANCISCO, June 17, 2025 (GLOBE NEWSWIRE) -- Omada Health (Nasdaq: OMDA), the virtual between-visit healthcare provider, released new data1 demonstrating that Omada's GLP-1 companion program significantly improved persistence rates for GLP-1 medications. Evidence suggests that persistence on a GLP-1 is associated with greater weight loss.2 Omada's analysis found that those who persisted with their GLP-1 medication achieved weight loss results similar to what has been found in controlled research settings.1 Despite a growing body of evidence supporting vast clinical benefits of GLP-1s,3 while results vary widely, one study showed that one-third of people stopped taking their GLP-1 in the first month, and less than half stayed on for more than 12 weeks.4 These data suggest that in the real world, factors like non-persistent medication use mean that many who use GLP-1s for weight management may not see the results reflected in clinical trials. 'While published literature illustrates the incredible potential of GLP-1s, these outcomes are generally limited to those who consistently use their medication long enough to see benefit. In the real world many patients do not receive the necessary support for this to be a reality,' said Sarah Linke, PhD, MPH, Senior Director, Clinical & Translational Research, Omada Health. 'Omada's GLP-1 companion program helps individuals maintain their medication regimen and, in this analysis, helped members achieve clinical trial-level outcomes in real-world settings, which sets the stage for cardiometabolic disease reduction.' Omada analyzed 1,124 members without diabetes who self-reported GLP-1 use to assess the impact of its Enhanced GLP-1 Care Track on medication persistence through 24 weeks. Self-reported medication initiation and persistence were confirmed using objective pharmacy claims data. Previous real-world studies have demonstrated a wide range in medication persistence rates at 12 weeks (42%4 to 80%5) and 24 weeks (33%6 to 74%5) after starting GLP-1s. In contrast, members included in this analysis of Omada's Enhanced GLP-1 Care Track demonstrated higher persistence rates—94% through 12 weeks and 84% through 24 weeks.1 This analysis also found the average weight loss for Omada members that persisted on their medication through 24 weeks was closely aligned with 24-week outcomes from a recent head-to-head clinical trial7 comparing tirzepatide and semaglutide in a similar population. Whereas Omada members who stopped taking their GLP-1 medication any time before 24 weeks lost an average of 7.4% of their body weight, those who remained on their medication through 24 weeks lost an average of 12.1%—a 64% relative increase.1 Providing the right kind of support to enable members to persist with their GLP-1 medication long enough to see benefits can help them achieve clinical trial-level weight loss outcomes, setting the stage for cardiometabolic disease risk reduction. Omada's Enhanced GLP-1 Care Track provides targeted resources for members as they move through their GLP-1 use journey. Members in this companion program receive high-touch care team support to help overcome common barriers to persistence – from education around dose titration, common side effects, and mitigation strategies to nutrition guidance and support from Exercise Specialists to combat muscle loss. Members who plan to stop their medication due to access concerns may receive resources that help them understand their options and navigate the larger healthcare ecosystem. 'We are in the fortunate position that more patients are getting access to these transformative medications,' said Wei-Li Shao, President, Omada Health. 'However, with increased access comes the responsibility to ensure GLP-1 use remains cost-effective by supporting sustainable long-term health benefits. We believe these findings highlight the potential of Omada's program to enhance clinical outcomes with improved medication persistence and a focus on engagement in healthy lifestyle behavior changes." This analysis was conducted through Omada's Insights Lab as part of the ANSWERS (ANalyzing Success of WEight medication with Real-world evidence and Stats) initiative, and builds on more than a decade of insights and 29 peer-reviewed publications assessing the efficacy of behavior change programs to improve chronic disease management. Omada HealthOmada Health is a virtual-first healthcare provider that nurtures lifelong health, one day at a time. Omada care teams implement clinically-validated behavior change protocols for individuals living with diabetes, hypertension, prediabetes, and musculoskeletal issues. With more than a decade of experience and data, and 29 peer-reviewed publications that showcase its clinical and economic results, Omada is designed to help improve health outcomes and contain healthcare costs. Omada's scope exceeds 2,000 customers, including health plans, health systems, and employers ranging in size from small businesses to Fortune 500s. The foundation of Omada's success is a strong, vibrant work culture, which helped earn the company the distinction of becoming an officially certified Great Place to Work®. An industry leader, Omada was the first virtual provider to join the Institute for Healthcare Improvement's Leadership Alliance, reflecting the aim to complement primary care providers for the benefit of members, and affirming its guarantee to every partner: Omada works differently. ContactsRose Ramsethpress@ 1Chang, H., Devaraj, S. M., Naqvi, J. B., & Linke, S. (2025). GLP-1 Medication Persistence, a Key Component of Weight Loss. Omada Health. GLP-1 Medication Persistence, a Key Component of Weight Loss. Omada Health. H., Butsch, W. S., Schulte, R., Casacchia, N. J., Le, P., Boyer, C. B., Griebeler, M. L., Burguera, B., & Rothberg, M. B. (2025). Changes in weight and glycemic control following obesity treatment with semaglutide or tirzepatide by discontinuation status. Obesity, 2025, 1-11. Y., Choi, T., & Al-Aly, Z. (2025). Mapping the effectiveness and risks of GLP-1 receptor agonists. Nature, 31, 951–962. Health Intelligence®. (2024, May). Real‑world trends in GLP‑1 treatment persistence and prescribing for weight management [PDF]. Blue Cross Blue Shield Association. Retrieved June 16, 2025, from 5Hankosky, E. R., Karishma, D., Chinthammit, C., Grabner, M., Stockbower, G., He, X., Mojdami, D., Wenziger, C., & Gibble, T. H. (2025). Real-world use and effectiveness of tirzepatide among people without evidence of type 2 diabetes in the United States. Diabetes & Metabolism, 51 (3), 101636. P. P., Urick, B. Y.,Marshall, L. Z., Friedlander, N., Qiu, Y., & Leslie, R. S. (2024). Real-world persistence and adherence to glucagon-like peptide-1 receptor agonists among obese commercially insured adults without diabetes. Journal of Managed Care & Specialty Pharmacy, 30 (8), 860-867. 7Aronne, L. J., Horn, D. B., le Roux, C. W., Ho, W., Falcon, B. L., Valderas, E. G., Das, S., Lee, C. J., Glass, L. C., Senyucel, C., & Dunn, J. (2025). Tirzepatide as Compared with Semaglutide for the Treatment of Obesity, NEJM, 2025. in to access your portfolio
