By Tristan Manalac Pictured: Entrance to the Department of Health and Human Services in Washington, DC/iStock The Department of Health and Human Services in a supplemental court filing posted late last week has suggested that Johnson & Johnson’s blockbuster psoriasis therapy Stelara (ustekinumab) might soon be “deselected” from the Inflation Reduction Act’s Drug Price Negotiation Program. The development comes after the FDA last week approved Amgen’s Wezlana (ustekinumab-auub), an interchangeable biosimilar to Stelara. In May 2023, Amgen and J&J settled their patent dispute over the biosimilar challenge to Stelara, allowing the entry of Wezlana “no later than January 1, 2025.” Under the current negotiation guidelines, the Centers for Medicare and Medicaid Services can reconsider a drug product for price negotiations when it is “subject to meaningful competition.” HHS referred to this provision in a separate October 2023 court filing, supporting its prior motion to dismiss a lawsuit filed by various ...
The US Food and Drug Administration (FDA) has issued a warning against the use of the glucose management product, Dr Ergin’s SugarMD Advanced Glucose Support. The regulator asked consumers not to buy and to immediately stop using the product, promoted and sold for blood glucose management due to hidden drug ingredients. Several SugarMD products are sold online on Amazon as supplements for those with type 1 and type 2 diabetes. One of the supplements, GlucoDefense to maintain glucose metabolism is advertised to produce “truly remarkable [results] within just 6 weeks”. In laboratory tests carried out by the FDA, active ingredients glyburide and metformin were confirmed to be present in the drug. Glyburide and metformin are in several FDA drugs used to treat type-2 diabetes that can only be obtained with a prescription. Both of these ingredients can pose a serious risk to consumers. Glyburide can result in unsafe drops in ...
Amidst the rapidly growing revenue share of metabolic disease drugs in its pipeline, Eli Lilly is looking to delve deeper into its pharmaceutical exploration of obesity therapeutics, said medical director Axel Haupt. Haupt was speaking at a panel at the ongoing Bio-Europe 2023 conference, where he said drugs like Lilly’s Mounjaro (tirzepatide) carry potential to be used in for several conditions. The US Food and Drug Administration approved Eli Lilly’s Mounjaro for diabetes in May 2022, followed by the European Union in September 2022. The drug is administered via injection in a once-weekly regimen. Haupt revealed that an FDA approval for Mounjaro for treating obesity could be expected within the next 12 months. Obesity and diabetes treatment would likely not be the only use for Mounjaro, given the presence of GIP receptors in other locations like the adipose tissue, Haupt said. Eli Lilly sees potential use for the drug in ...
Don Tracy, Associate Editor The rise in popularity of GLP-1 weight-loss drugs, such as Ozempic, Wegovy, and Mounjaro, has had a wide-reaching impact across the healthcare industry and beyond. Image Credit: Adobe Stock Images/Dimid The launch of multiple glucagon-like peptide (GLP-1) drugs for weight loss—such as Ozempic, Wegovy, and Mounjaro—is expected to cause a major shakeup in the stock market, as millions of Americans are set to shed hundreds of millions of pounds over the next decade while reshuffling trillions of dollars in the process, according to expert analysis. Not only have these treatments helped patients shed a significant amount of pounds, but they have also shown efficacy treating other conditions as well. A recent drug trial by Novo Nordisk found that semaglutide, the active ingredient in Ozempic and Wegovy, could help people with kidney failure as well. As shares of Novo Nordisk and Mounjaro developer Eli Lilly increase, dialysis ...
Eli Lilly is acquiring Beam Therapeutics’ opt-in rights to three Verve Therapeutics gene-editing therapies for cardiovascular conditions. The deal comes four months after the pharmaceutical giant began a partnership on a preclinical Verve gene-editing therapy for a different target. By FRANK VINLUAN Eli Lilly signaled its growing interest in genetic medicines for cardiovascular conditions when it partnered with Verve Therapeutics earlier this year, committing to share in development of a preclinical gene-editing therapy addressing a key heart target. The pharmaceutical giant is now adding more cardiovascular disease drug prospects, pledging $250 million to secure the right to opt into development and commercialization of three additional Verve gene-editing therapies for other key targets. This time, however, the cash isn’t going to Verve. Lilly is paying Beam Therapeutics, whose base-editing technology is used in Verve’s experimental genetic medicines. Their original alliance, started in 2019, gave Beam the option to share in the ...
Intuitive Surgical Chief Medical Officer Dr. Myriam Curet [Photo courtesy of Intuitive Surgical] Intuitive Surgical (Nasdaq: ISRG)+ executives say they see benefits to their business from GLP-1 weight loss drugs, even if investors aren’t quite so sure.Intuitive’s stock slid in after-hours trading today after the company posted Q3 results that exceeded analysts’ expectations on profits but fell short on sales. Even if they had beat The Street on both counts, it’s not clear investors would have reacted any differently — just look at what happened to Intuitive’s stock price under that exact scenario after Q2.In Q2, the company said bariatric procedure growth slowed due to patient interest in weight loss drugs. Related: Analysts expect minor GLP-1 impact on insulin pumps, but a boost for CGMs“Bariatric procedures represent between four and 5% of total global procedures,” CFO Jamie Samath said on the Q3 call. “Based on third-party data, we believe we continue to gain market share in the ...
BY JIM HAMMERAND Intuitive Surgical Chief Medical Officer Dr. Myriam Curet [Photo courtesy of Intuitive Surgical] Intuitive Surgical (Nasdaq: ISRG)+ executives say they see benefits to their business from GLP-1 weight loss drugs, even if investors aren’t quite so sure. Intuitive’s stock slid in after-hours trading today after the company posted Q3 results that exceeded analysts’ expectations on profits but fell short on sales. Even if they had beat The Street on both counts, it’s not clear investors would have reacted any differently — just look at what happened to Intuitive’s stock price under that exact scenario after Q2. Related: Analysts expect minor GLP-1 impact on insulin pumps, but a boost for CGMs So it was no surprise that the very first question for Intuitive leaders from analysts on today’s Q3 earnings call focused on the impact of GLP-1 drugs on bariatric procedures. “I think in the short term, we will see patients who are considering or are ...
Amazon Pharmacy is working to speed up prescription medication delivery in College Station, Texas, through its free drone delivery service, the company announced Wednesday. With drones, Amazon said prescriptions can be delivered within 60 minutes. Customers in College Station can sign up for the drone delivery service by scheduling a free yard consultation, in which a local yard survey specialist will come to customers’ homes and examine their yards. If the specialist determines that the yard is suitable, then Amazon will provide a marker where the drone can deliver packages. Then when eligible customers order their medications, they can select drone delivery at checkout. The service is available for more than 500 medications that treat common conditions, such as flu, asthma and pneumonia. These medications include Levofloxacin, Bactrim, Atorvastatin and Levothyroxine. For many of these conditions, swift access to treatment is vital, but that doesn’t always happen, said Dr. Vin ...
The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes. By FRANK VINLUAN Novo Nordisk has again turned to dealmaking to expand its pipeline, but rather than adding yet another weight loss drug prospect the company is acquiring a molecule that’s a potential treatment for uncontrolled hypertension and chronic kidney disease. The Danish pharmaceutical giant has agreed to buy ocedurenone, a drug that KBP Biosciences has advanced to Phase 3 testing. Specific financial details, such as an upfront payment and milestones, were not disclosed Monday, but Novo Nordisk said it could end up paying out up to $1.3 billion. The target of KBP’s drug is the mineralocorticoid receptor, whose overactivation is associated with hypertension and chronic kidney ...
The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again. The Danish company now expects full-year sales to grow between 32% and 38% at constant exchange rates. The new projection, released on Friday, represents a 5-percentage-point increase on both ends of the range from an August estimate, which itself was 3 percentage points higher than a previous forecast from April. Novo’s share price at one point traded at around $104 on the New York Stock Exchange on Friday, a new all-time high. Huge demand for Ozempic—which is often used off-label to treat obesity—plus new discount adjustments for Ozempic and Wegovy in the U.S. drove the updated sales outlook, Novo explained in a release. Novo on Friday also dialed up its estimated profit growth rate by 9 percentage points to a range of 40% to 46%. The company released the ...
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