Latest news with #semaglutide
Reuters
2 days ago
- Business
- Reuters
Wegovy maker Novo faces fee demand after losing copycat drug lawsuit
May 29 (Reuters) - (Billable Hours is Reuters' weekly report on lawyers and money. Please send tips or suggestions to opens new tab) Danish drugmaker Novo Nordisk ( opens new tab is facing a request for hundreds of thousands of dollars in attorney fees after a judge dismissed its lawsuit against a Florida pharmacy for selling products containing semaglutide, the active ingredient in its blockbuster weight-loss and diabetes drugs Wegovy and Ozempic. U.S. District Judge William Jung in Tampa, Florida, dismissed Novo's lawsuit, opens new tab against Brooksville Pharmaceuticals earlier this month, dealing the company a setback in a wave of similar lawsuits against compounding pharmacies that sold semaglutide-containing drugs. Brooksville's lawyers this week asked the judge to award them more than $439,000 in attorney and expert fees, opens new tab and costs after fighting off Novo's claims that it violated a state law barring sales of adulterated and misbranded drugs. Compounded drugs are custom-made medicines that are based on the same ingredients as branded drugs. Federal regulations allow compounded versions to be sold to meet demand if a drug is in short supply. Both Wegovy and Ozempic were on the U.S. Food and Drug Administration's drug shortage list from March 2022 to February 2025. Jung ruled in part that the Danish drugmaker's claims were rendered moot after the FDA declared that the shortages for Ozempic and Wegovy were over. The judge also found that Novo failed to find any patient who was actually harmed by Brooksville's compounded drug, a point that was emphasized by the pharmacy's lawyers at Frier Levitt in their Tuesday fee request. "Novo was not aware of any instances of patient harm caused by Brooksville's semaglutide compounds. And yet, Novo continued to pursue litigation even after it became clear that its case was without merit," the fee motion said. Novo said in a statement that its lawsuit against Brooksville Pharmaceuticals was dismissed "as a legal matter," and asserted that U.S. law prohibits compounders from making or selling "knockoff 'semaglutide drugs' with rare exceptions." "Moving forward, any compounder that mass produces or sells knockoff drugs is breaking the law and compromising patient safety," the company said. A spokesperson for Novo did not immediately respond to a request for comment. Matthew Modafferi, a lawyer for the pharmacy at Frier Levitt, declined to comment on the fee petition. Analysts forecast that the obesity drug market could be worth as much as $150 billion by the early 2030s. Both Novo and Eli Lilly (LLY.N), opens new tab have waged an active campaign to crack down on medical spas, weight-loss clinics, compounding pharmacies and online sellers in a bid to stop them from selling products claiming to contain the active ingredients in their drugs. Novo said it has filed nearly 120 lawsuits across 34 states, and obtained 28 final judgments and permanent injunctions. The case before Jung is at least the fourth lawsuit Novo has filed and lost over compounded versions of its weight-loss drug in the Middle District of Florida. One of the defendants, Wells Pharmacy Network, sought more than $250,000 in attorney fees and costs for winning its case in the lower court. But U.S. Magistrate Judge Philip Lammens denied the request, opens new tab, finding it was premature for Wells Pharmacy to seek attorney fees while Novo was pursuing an appeal. – Alphabet's Google (GOOGL.O), opens new tab and chipmaker Qualcomm (QCOM.O), opens new tab are keeping teams of lawyers who have defected from large U.S. law firm Paul Weiss, court records show. Karen Dunn, Jeannie Rhee, William Isaacson and Jessica Phillips split from Paul Weiss last week, after it struck a deal with the Trump White House in March to lift an executive order targeting the firm's legal business operations. The four attorneys and their new firm Dunn Isaacson Rhee are defending Google in the U.S. government's lawsuit accusing it of illegally monopolizing digital advertising markets. Other Paul Weiss attorneys are still on the matter, as are teams from law firms Freshfields and Axinn Veltrop. Google declined to comment, and it has denied any wrongdoing. Dunn and Isaacson separately are continuing to represent Qualcomm in a lawsuit in the federal court in Delaware, court records show. A group of Paul Weiss lawyers are also on that case. Isaacson and Phillips remain on the defense team for Ultimate Fighting Championship in an antitrust lawsuit with Latham & Watkins and other Paul Weiss lawyers, a filing, opens new tab showed this week. The attorneys declined to comment. Paul Weiss did not immediately respond to a request for comment. – Outdoor advertising giant Clear Channel (CCO.N), opens new tab has asked a federal judge in Manhattan to award it $3.1 million in fees following a five-year legal battle with the city of New Rochelle, New York over the ownership of its 16 billboards within the city limits. Clear Channel said its lawyers from Chicago-founded Sidley Austin spent roughly 3,800 hours litigating its 2020 lawsuit against New Rochelle's "attempted, unconstitutional taking" of its billboards. The lawsuit, filed in 2020, alleged that New Rochelle sought to remove the company's billboards without due process or compensation and gave those licenses to one of Clear Channel's competitors, which paid New Rochelle millions for exclusivity rights. Sidley said in a court filing, opens new tab that its requested hourly rates of up to $1,400 for senior partners are "significantly below" the firm's standard rates for work in the Southern District of New York. A Clear Channel spokesperson did not immediately respond to a request for comment, nor did the city of New Rochelle's lawyers at New York law firm Harris Beach Murtha. Read more: US agencies face fees over faulty cases, Ford seeks $300 million from lemon law lawyers Settlements mount against law firm caught up in bankruptcy judge's secret romance Amazon, Apple seek legal fees as sanction in US consumer lawsuit
Associated Press
3 days ago
- Business
- Associated Press
Veru Reports Positive Safety Results from Phase 2b QUALITY Study: Enobosarm Added to Semaglutide Led to Greater Fat Loss, Preservation of Muscle, and Fewer Gastrointestinal Side Effects Compared to Semaglutide Alone
--Phase 2b QUALITY clinical study topline safety data shows that the enobosarm + semaglutide combination had a positive safety profile compared to semaglutide alone-- --Based on Phase 2b QUALITY trial efficacy and safety data, enobosarm 3mg will advance as the proposed oral dose for the Phase 3 clinical program-- --Enobosarm 3mg + semaglutide combination had the added benefit of fewer gastrointestinal side effects (Diarrhea, Nausea, and GERD) compared to semaglutide alone-- --Enobosarm 3mg added to semaglutide resulted in the highly selective loss of fat mass, accounting for 99% of the total weight lost, while preserving lean mass-- --With this positive Phase 2b QUALITY study, Veru has requested an End of Phase 2 meeting with FDA to provide regulatory clarity on the Phase 3 clinical program-- --The topline efficacy and safety data for the Phase 2b extension maintenance study to assess whether enobosarm monotherapy prevents the fat and weight regain following discontinuation of semaglutide are expected in the second quarter-- MIAMI, FL, May 28, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced positive topline safety results from the Phase 2b QUALITY clinical study, a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial, designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to enhance fat loss and to prevent muscle loss in older patients (≥60 years of age) receiving semaglutide (Wegovy®) for chronic weight management. Positive Topline Safety Results for the Phase 2b QUALITY Clinical Trial Adverse events (AEs) and adverse events of special Interest (see table below). In the Phase 2b QUALITY clinical trial, enobosarm and semaglutide GLP-1 RA combination had a positive safety profile. There were no increases in gastrointestinal side effects, no evidence of drug-induced liver injury (as defined by Hy's law), and no increases in obstructive sleep apnea at any dose of enobosarm compared to placebo (semaglutide alone). There were no AEs of increases in prostate specific antigen in men. There were no AEs related to masculinization in women. There were no reports of suicidal ideation observed (Columbia-Suicide Severity Rating Scale). No treatment related serious adverse events (SAEs) were observed in the QUALITY study. There were 4 non-treatment related SAEs equally distributed between the treatment groups. At the proposed Phase 3 clinical program dose of enobosarm 3mg, one subject experienced an adverse event of transient, mild increase in alanine aminotransferase (ALT), which returned to baseline while remaining on enobosarm. There were no accompanying increases in aspartate aminotransferase (AST), alkaline phosphatase or total bilirubin. The enobosarm 3mg + semaglutide group had the added benefit of fewer AEs reported for certain gastrointestinal side effects (Diarrhea, Nausea, and Gastroesophageal Reflux Disease) compared to placebo + semaglutide. 'The safety results from the Phase 2b study are positive and suggest that the addition of enobosarm to semaglutide treatment doesn't worsen, and in some cases appears to improve gastrointestinal side effects', said Louis J. Aronne, MD, an obesity expert, past president of the Obesity Society and a scientific advisor and consultant to Veru. Topline Phase 2b QUALITY clinical trial safety summary: Adverse Events1 and Adverse Events of Special Interest 1 Adverse events (at least 4 subjects in any dose group) from Day 1 to Day 112 2 Graded as mild in severity, levels returned to below baseline while on drug, no associated increase in alkaline phosphatase or total bilirubin 3 All graded as mild in severity, all returned to or toward baseline/upper limit of normal, no associated increases in alkaline phosphatase or total bilirubin 'We previously shared positive results from the Phase 2b QUALITY study, indicating that enobosarm can selectively enhance fat loss while preserving lean mass and physical function in older patients using semaglutide for weight loss. Today, we announced that the topline safety data from the Phase 2b QUALITY clinical study confirms that enobosarm has a positive safety profile with the added benefit of reducing certain gastrointestinal side effects that patients commonly experience with semaglutide and other GLP-1 receptor agonists. Based on these efficacy and safety results, the enobosarm 3mg dose has been selected to advance into our proposed Phase 3 study,' said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. 'We have submitted a request for an End of Phase 2 meeting with FDA, which we anticipate will take place in the third quarter of calendar year 2025. The meeting is expected to provide regulatory clarity on the design of our planned Phase 3 clinical program. Further, we are expecting the topline efficacy and safety results for the Phase 2b extension maintenance study this quarter, which will show us whether enobosarm monotherapy can stop the fat and weight regain that generally happens when patients discontinue GLP-1 receptor agonist treatment. Finally, we look forward to reporting the full Phase 2b QUALITY and extension clinical trial efficacy and safety data at future leading scientific conferences and in prestigious publications.' Positive Topline Efficacy Results for the Phase 2b QUALITY Clinical Study: Enobosarm in Combination with GLP-1 RA Drugs Makes Weight Reduction More Tissue Selective for Fat Loss While Preserving Lean Mass and Physical Function In January 2025, the Company announced positive topline results from the Phase 2b QUALITY clinical study, which is a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in older patients (≥60 years of age) receiving semaglutide (Wegovy®) for chronic weight management. Topline Efficacy Results Topline Primary Endpoint – Percent Change in Total Lean Mass In the topline efficacy analysis, the trial met its prespecified primary endpoint with a statistically significant and a clinically meaningful benefit in all patients receiving enobosarm + semaglutide versus placebo + semaglutide at 16 weeks in total lean mass (71% relative reduction in lean mass loss, p=0.002). Notably, the enobosarm 3mg + semaglutide was the best dose with a 99.1% mean relative reduction in loss of lean mass (p <0.001). The enobosarm 6mg + semaglutide dose did not provide any additional benefit over the 3mg dose in preserving lean mass. Topline Secondary Endpoints: Total Fat Mass Enobosarm + semaglutide treatment resulted in dose dependent greater loss of fat mass compared to placebo + semaglutide with the enobosarm 6mg dose having a 46% greater relative loss of fat mass compared to placebo + semaglutide group at 16 weeks (p=0.014). Weight Loss and Tissue Composition of Weight Loss Although mean weight loss by DEXA was similar in the enobosarm + semaglutide groups compared to semaglutide alone at 16 weeks, the composition of total weight loss shifted toward greater and more selective fat loss with enobosarm treatment: Physical Function Measured by the Stair Climb Test The Stair Climb Test is used to measure physical function and is an activity of daily living that measures functional muscle strength, balance and agility. Decline in Stair Climb Test performance in older adults is predictive of increased risk for mobility disabilities, gait difficulties, falls, bone fractures, hospitalizations, and mortality. As a reference point, stair climb power declines by -1.38% per year with aging according to Van Roie E, et al. PLOS ONE.14:e0210653, 2019. Stair Climb Test Results: A responder analysis was conducted using a greater than 10% decline in stair climb power at 16 weeks as the cutoff, which corresponds to approximately 7.5 years' worth of stair climb power loss due to natural aging. Topline Efficacy Results Conclusion The Phase 2b QUALITY clinical trial is the first human study to show that older patients who are overweight or have obesity and receiving semaglutide, a GLP-1 receptor agonist, are at higher risk for accelerated loss of lean mass and associated physical function decline. Enobosarm added to semaglutide enhanced loss of fat, with 99% of the total weight loss attributable to fat. In addition, enobosarm treatment preserved lean muscle mass, which translated into an improvement in physical function as measured by the Stair Climb Test compared to semaglutide alone. Enobosarm represents a novel drug that improves body composition by driving a more selective and greater loss of adiposity (fat mass) and preserving both lean mass and physical function in patients receiving semaglutide for chronic weight management. Phase 2b Extension Maintenance Study After completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial, participants continued into a Phase 2b extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3mg, or enobosarm 6mg as monotherapy in a blinded fashion for 12 weeks. The Phase 2b extension clinical trial is evaluating whether enobosarm, by preserving muscle mass, also prevents the fat regain that generally occurs after stopping a GLP-1 RA. The topline efficacy and safety results for the Phase 2b extension clinical study are expected this quarter. Regulatory Next Steps As the Phase 2b QUALITY clinical trial is a positive study, we have requested an End of Phase 2 meeting with the FDA. During the preIND FDA meeting, FDA provided general comments about a regulatory path forward for enobosarm as a drug that improves body composition during weight loss including input on the Phase 3 clinical program design. As a path forward, we plan to propose a Phase 3 clinical program that is similar to the positive Phase 2b QUALITY clinical trial. The proposed Phase 3 clinical trial design is a double-blind, placebo-controlled study in older patients (≥60 years of age) who have obesity or who are overweight and who are eligible for treatment with GLP-1 RA. The GLP-1 RA may be either Wegovy® (semaglutide) and/or Zepbound® (tirzepatide). Patients will be randomized to oral daily enobosarm or matching placebo. All subjects will start and receive GLP-1 RA during the study. The proposed primary objective will be the effect of enobosarm on physical function measured by the Stair Climb Test at 24 weeks. Proposed key secondary objectives will be to assess the effect of enobosarm on total lean mass, total fat mass, insulin resistance, and hemoglobin A1c at 24 weeks. After the Phase 3 clinical trial ends at 24 weeks of treatment, the plan is to continue to measure total lean mass, total body weight, stair climb power physical function, total fat mass, bone mineral density, insulin resistance, and hemoglobin A1c up to 68 weeks to capture the longer-term benefits of enobosarm improvements on body composition for greater loss of adiposity or fat, weight reduction, and preservation of both lean mass and bone. Novel Modified Release Oral Enobosarm Formulation is on Track to be Available for Phase 3 Clinical Studies and Commercialization Veru is currently developing a novel, patentable, modified release oral formulation for enobosarm. The actual formulation, pharmacokinetic release profile(s), and method of manufacturing will be the subjects of future patent applications. If issued, the expiry for the new modified release oral enobosarm formulation patent is expected to be 2045. The new enobosarm formulation has completed animal trials and is anticipated to be in Phase 1 bioavailability clinical trials during the first half of calendar 2025. The expectation is that this novel modified release oral enobosarm formulation will be available for the Phase 3 clinical studies and for commercialization. Forward-Looking Statements This press release contains 'forward-looking statements' as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the full data set, including safety data, from the Phase 2b QUALITY study of enobosarm discussed above will be made available and whether that data will align with disclosed topline results or change any of the conclusions drawn from the topline data; whether and when the Company will present the full data from the Phase 2b QUALITY study and in what forum; whether and when the Company will present data from the extension maintenance study and whether such extension study will successfully meet any of its endpoints; whether and when the Company will have an end-of-Phase-2 meeting with FDA and the results of any such meeting; whether the results of the Phase 2b QUALITY study of enobosarm will be replicated to the same or any degree in any future Phase 3 studies; the expected costs, timing, patient population, design, endpoints and results of the planned Phase 3 studies of enobosarm as a body composition drug or any other Phase 3 studies; whether the Company and FDA will align on the Phase 3 program for enobosarm as a body composition drug and whether any such program will be able to be funded by the Company; whether the modified-released formation of enobosarm will be developed successfully and whether such formulation will have the same effectiveness as the current formulation, and whether and when such modified-release formulation will be available for any planned or future clinical studies; whether and when any patents will actually issue regarding such modified-release formulation and what any expiration dates of any such patents might be; whether the Company will be able to obtain sufficient GLP-1 RA drugs in a timely or cost-effective manner in the planned Phase 3 study or other Phase 3 studies; whether FDA will require more than one Phase 3 study for enobosarm as a body composition drug; whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss in any planned or other Phase 3 studies or if approved, in clinical practice; whether patients treated with enobosarm for a longer period of time than in the Phase 2b QUALITY study will have a greater loss of adiposity or greater weight loss than with semaglutide alone; and whether and when enobosarm will be approved by the FDA as a body composition drug. The words 'anticipate,' 'believe,' 'could,' 'expect,' 'intend,' 'may,' 'opportunity,' 'plan,' 'predict,' 'potential,' 'estimate,' 'should,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company's product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the Company's ability to reach agreement with FDA on study design requirements for the Company's planned clinical studies, including for the Phase 3 program for enobosarm as a body composition drug and the number of Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of subjects in clinical studies or an inability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business; any products of the Company, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company's products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company's ability to protect and enforce its intellectual property; costs and other effects of litigation, including product liability claims and securities litigation; the Company's ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company's ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2024, and subsequent quarterly reports on Form 10-Q. These documents are available on the 'SEC Filings' section of our website at Wegovy® is a registered trademark of Novo Nordisk A/S. Zepbound® is a registered trademark of Eli Lilly and Company. Investor and Media Contact: Samuel Fisch Executive Director, Investor Relations and Corporate Communications Email: [email protected]
Globe and Mail
3 days ago
- Business
- Globe and Mail
Novo Nordisk's 52% Plunge: Is the Company Fumbling Its Leadership in the $150 Billion Weight Loss Market?
Nothing attracts competition like the opportunity for profits, and the weight loss drug market has become arguably the healthcare industry's hottest opportunity in recent memory. Novo Nordisk(NYSE: NVO) has enjoyed tremendous success with semaglutide, the proprietary drug in Ozempic and Wegovy. However, competition is picking up with multiple next-generation drugs working through clinical testing. Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now. Continue » The market is worried about Novo Nordisk's grip on the weight loss market, evidenced by the stock plummeting over 52% from its mid-2024 high. Does Wall Street have it wrong, or is Novo Nordisk fumbling a generational growth opportunity? Here is what you need to know. The competition is heating up in the weight loss market Research by Morgan Stanley estimates the weight loss market could grow from roughly $15 billion last year to approximately $150 billion by 2035. GLP-1 agonists are currently the drug of choice, which slow digestion and suppress the patient's appetite. Novo Nordisk has an estimated 62% market share of the GLP-1 agonist market, with archrival Eli Lilly accounting for another 35%. Investors are looking ahead to next-generation drugs that could deliver better results with fewer side effects. That includes next-generation injectable treatments and pill-form drugs, which most patients probably prefer to a needle. Novo Nordisk hopes to receive regulatory approval to market and sell its semaglutide weight loss drug Wegovy in pill form by year-end. Meanwhile, CagriSema, currently in phase 3 clinical trials, is the company's next-generation injectable drug. However, it has struggled to stand out from existing treatments in late-stage clinical tests. Will these products maintain Novo Nordisk's weight loss leadership? It's hard to tell. Eli Lilly's orforglipron has performed well in its initial phase 3 clinical testing. It's an oral pill and the first small-molecule GLP-1 agonist to pass a phase 3 study, which is potentially significant because small-molecule drugs are generally easier and cheaper to manufacture. There are dozens of weight loss drugs in various development stages across the industry, so competition is coming. Don't assume Novo Nordisk will lose its crown Novo Nordisk's competitors were never going to stand and watch it dominate a $150 billion opportunity, but that doesn't necessarily mean Novo Nordisk will lose its crown. Investors have grown afraid of competition, but the drug development process is extremely daunting. Far more drugs fail the regulatory process than reach the market. Pfizer, a fellow pharmaceutical heavyweight, had hopes to crack the weight loss market with its oral GLP-1 agonist danuglipron, but it abandoned development in April after it potentially caused a liver injury in a patient during clinical tests. Several factors ultimately decide which treatments patients choose, including efficacy, price, and side effects. In other words, it's probably unfair to conclude what will happen until these new and upcoming drugs have been on the market for a while. Novo Nordisk and Eli Lilly may continue to dominate market share, though they could trade blows, and the balance between them could shift. The stock's slide mitigates a lot of risk Still, investors and the market have assumed that Novo Nordisk will ultimately cede market share. Analysts have dramatically lowered their long-term earnings growth estimates for Novo Nordisk. But here is the good news -- the stock already reflects these lower expectations. Novo Nordisk trades at a price-to-earnings (P/E) ratio of 20 today, down from roughly 50 over the summer. Even if the market is correct and Novo Nordisk grows by an average of 14% annually, today's valuation is still attractive for that growth. That wouldn't be the case at 50 times earnings, but its current PEG ratio of 1.4 is an attractive price tag for an industry leader in a high-growth industry like this. There are always risks in the pharmaceutical business. Novo Nordisk could suffer an unexpected setback or drug failure, or a competitive drug could be so good that it tilts the balance of the weight loss market away from Novo Nordisk. Still, Novo Nordisk is a proven industry leader and probably deserves some more faith until proven otherwise. Barring a worst-case scenario, the stock has a good shot to work out well for long-term investors from these discounted prices. Should you invest $1,000 in Novo Nordisk right now? Before you buy stock in Novo Nordisk, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Novo Nordisk wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider whenNetflixmade this list on December 17, 2004... if you invested $1,000 at the time of our recommendation,you'd have $639,271!* Or when Nvidiamade this list on April 15, 2005... if you invested $1,000 at the time of our recommendation,you'd have $804,688!* Now, it's worth notingStock Advisor's total average return is957% — a market-crushing outperformance compared to167%for the S&P 500. Don't miss out on the latest top 10 list, available when you joinStock Advisor. See the 10 stocks » *Stock Advisor returns as of May 19, 2025 Justin Pope has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Pfizer. The Motley Fool recommends Novo Nordisk. The Motley Fool has a disclosure policy.
Forbes
24-05-2025
- Health
- Forbes
‘Ozempic Teeth', ‘Tongue', ‘Breath' As Possible GLP-1 Med Oral Effects
People have been mouthing off on social media about the different things that Ozempic and other glucagon-like peptide-1 receptor agonists can supposedly do to, well, the inside of your mouth. There's what's been dubbed 'Ozempic teeth,' which encompasses dental problems like gum disease and tooth decay. But it's not just the tooth and nothing but the tooth that supposedly may be affected. There's also 'Ozempic breath,' which is being used to describe the bad breath that reportedly may occur. Then there's 'Ozempic tongue,' which people are using to describe how such meds may affect the tongue, including changes in taste. In this case, changes in taste doesn't mean going from liking sweater vests to going all Boho-chic. Instead, it refers to dysgeusia, a taste disorder, where you feel that all foods taste funny, like metallic, sweet, sour or bitter. I've already about other Ozempic (fill in body part here) terms that have circulating on social media like 'Ozmepic finger', 'Ozempic butt' and 'Ozempic feet.' The question then is do these claims about 'Ozempic teeth', 'Ozempic breath' and 'Ozempic tongue' have any teeth? Are they supported by scientific evidence? Or are they just more of the say-whatever-you-want-to-say-without-real-evidence that you see frequently on Instagram, TikTok, X and other social media platforms. Well, there is a case series published in a real medical journal called Medicine of people suffering xerostomia when taking semaglutide containing medications. Semaglutide is the stuff in Ozempic and Wegovy that can do the appetite suppression leading to weight loss thing. When you hear 'xerostomia,' you may be thinking, 'Zero what?' It's actually a scientific term for having a dry mouth due to insufficient saliva production. The case series described what happen to three female patients, ranging in ages from 27 to 46 years, who went to an oral medicine clinic in Saudia Arabia complaining about having severe dry mouths after taking semaglutide for weight loss for six to 16 weeks. While they were in the clinic, a modified Schirmer test confirmed their underproduction of saliva or hyposalivation. In one case, discontinuing the semaglutide resulted in normal saliva production being restored. In another case, starting pilocarpine, a medication that can stimulate salivary glands, did the trick. And in the third case, the patient decided to continue the semaglutide just long enough to achieve a target amount of weight loss. After this happened, her normal saliva flow resumed. It shouldn't be super surprising that taking GLP-1 agonists may affect saliva production. After all, studies of mice have suggested that glucagon-like peptide 1 can play a role in the production of saliva by salivary glands. Of course, a case series and mouse studies alone can't tell you how common hyposalivation may be with taking Ozempic, Wegovy, Zepbound, Mounjaro or other such medicaitons. GLP-1 agonist use. But multiple dental office websites do mention dry mouth as a side effect of GLP-1 agonist use. This suggests that it could be relatively common. Nevertheless, more rigorous scientific studies would be needed to get more exact numbers. Now, having xerostomia certainly doesn't mean having zero problems. Saliva doens't just give you something to swap when you kiss someone. You need enough saliva in your mouth to keep everything in there properly lubricated. Otherwise, things may start to stick with each other, like your tongue to the roof of your mouth. The Cleveland Clinic website lists other potential problems with a dry mouth such as a constant sore throat. difficulty eating, speaking or swallowing, hoarseness and increased thirst. There is also the possibility of, bingo, changes in taste, bad breath, mouth and tongue sores, gum problems and tooth decay. Ways of treating xerostomia including stopping or reducing whatever may be inhibiting saliva production, using lozenges like ones that contain sorbitol or taking medication that stimulate saliva production like cevimeline and pilocarpine. When it comes to accounting for taste or the taste changes that may occur with taking GLP-1 agonists, saliva underproduction may not be the only cause. Consider a study presented at ENDO 2024, which is the Endocrine Society's annual meeting that was held in guess what year, 2024. This study led by Mojca Jensterle Sever, PhD from the University Medical Centre in Ljubljana, Slovenia, consisted of 30 women with obesity and having half of them take semaglutide once a week and the other half taking a placebo for 16 weeks. At the end of the study, those taking semaglutide had greater sensitivity to different tastes based on trying different strips soaked with stuff that was supposed to taste sweet, sour, salty and bitter. Biopsies of their tongues also revealed that those taking semaglutide had greater activity of genes that may be involved in taste bud renewal and transmission of nerve signals related to taste. Moreover, functional MRI scans revealed that those who had taken semaglutide had increased activity in the angular gyrus of the parietal cortex of their brains when getting a solution of sweet stuff placed on their tongues prior to and following a meal. The angular gyrus helps organize different signals from different parts of your body that capture sensory information like your tongue. All of this also shouldn't be super surprising. After all, GLP-1 agonists are supposed to work by affecting GLP-1 receptors and in big part your appetite. The angular gyrus has plenty of GLP-1 receptors as well. Having sweet things taste more sweet and salty things taste may salty could reduce your desire to eat such foods. Of course, there's a difference between helpful alterations in taste and dysgeusia, where everything tastes so yucky that you can't get enough nutrients. More studies are needed, though, to confirm the aforementioned taste-altering findings and determine how common taste changes and dysgeusia may be. So, existing evidence does give breath to these 'Ozempic Breath', 'Ozempic Teeth' and 'Ozempic Tongue' claims. And these potential side effects should be reminders that GLP-1 agonists are not magical and 'easy' ways to lose weight. Don't opt for such medications simply because you don't want to bother with improving your diet and increasing your physical activity. Otherwise, you could end up taking it in the mouth.
Medscape
23-05-2025
- Health
- Medscape
GLP-1s Lower Pancreatitis Complications, Mortality in T2D
Patients with type 2 diabetes (T2D) who received glucagon-like peptide 1 (GLP-1) receptor agonists had a significantly lower risk of developing local or systemic complications — even if they developed acute pancreatitis — and showed more than a 50% reduction in risk for all-cause mortality than those who did not receive these medications. METHODOLOGY: Patients with T2D may experience heightened local and systemic complications from acute pancreatitis, often requiring prolonged and intensive care; however, data on outcomes among those treated with GLP-1s remain limited, highlighting a significant knowledge gap. Researchers conducted a retrospective cohort study using population-based data to evaluate the influence of GLP-1s on acute pancreatitis risk and associated outcomes in patients with T2D identified between January 2015 and October 2023. The analysis included 20,459 patients with T2D who received GLP-1s including semaglutide, liraglutide, dulaglutide, or tirzepatide (mean age, 58.1 years; 49.85% women); the patients were propensity score–matched with those not receiving these medications. The primary outcome was the development of acute pancreatitis and the subsequent clinical trajectory of affected patients, including the need for parenteral nutrition, the occurrence of systemic complications, and the incidence of local pancreatic complications. The secondary outcome was all-cause mortality. TAKEAWAY: Patients who received GLP-1s tended to have a lower risk for acute pancreatitis than those who did not, although this finding was not statistically significant. However, among patients with acute pancreatitis, those who received GLP-1s had a significantly lower risk of developing complicated pancreatitis (hazard ratio [HR], 0.32; P = .05) and a reduced need for parenteral nutrition (HR, 0.28; P = .01) than those who did not receive these GLP-1s. = .05) and a reduced need for parenteral nutrition (HR, 0.28; = .01) than those who did not receive these GLP-1s. The risks for systemic complications, including sepsis, acute kidney injury, shock, and the need for mechanical ventilation, were significantly lower in patients who received GLP-1s than those who did not ( P < .001 for all). < .001 for all). The risk for all-cause mortality was 55% lower in those who received GLP-1s than in those who did not (HR, 0.45; P < .001). IN PRACTICE: '[The study] results provide a compelling rationale for reconsidering GLP-1s as not only antidiabetic agents but also as key components in the management of diabetes-related complications, including AP [acute pancreatitis],' the study authors wrote. SOURCE: This study was led by Luis M. Nieto, MD, Division of Digestive Diseases, Emory School of Medicine in Atlanta. It was published online in The American Journal of Gastroenterology . LIMITATIONS: This study did not discuss any limitations. DISCLOSURES: This study received no specific funding. The authors reported having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. Credit Lead image: Tashatuvango/Dreamstime Medscape Medical News © 2025 WebMD, LLC Cite this: Edited by Archita Rai. GLP-1s Lower Pancreatitis Complications, Mortality in T2D - Medscape - May 23, 2025.
