Latest news with #Jardiance
The Hill
5 days ago
- Business
- The Hill
Two more cases challenging Medicare negotiation rejected in federal courts
Federal judges in Texas and Connecticut on Thursday ruled against arguments challenging the constitutionality of the Medicare Drug Price Negotiation Program, delivering two more blows to the pharmaceutical industry this week after an appeals court upheld the dismissal of a similar case. In Connecticut, the U.S. Second Circuit Court of Appeals upheld a decision granted by U.S. District Judge Michael P. Shea last year against pharmaceutical company Boehringer Ingelheim. The company's diabetes medication Jardiance was among the first 10 drugs chosen for Medicare negotiations and two more of its products were chosen for the following round of negotiations. In his 2024 ruling, Shea found that Boehringer Ingelheim could not demonstrate irreparable harm as a result of Medicare negotiations and also agreed with the federal government that the program did not violate laws such as the Medicare Act or the Administrative Procedures Act. Boehringer Ingelheim had also argued Medicare negotiations violated its First and Fifth Amendment rights. In its ruling on Thursday, the Second District Court of Appeals concurred with Shea's ruling, finding that the company's claims of unconstitutionality were not proven in their argument. 'Participation in the Negotiation Program is voluntary and thus does not entail an unlawful deprivation of rights,' the judgment stated. 'The program does not impose unconstitutional conditions on Boehringer's ability to participate in Medicare and Medicaid because the program is designed to promote the legitimate government purpose of controlling Medicare spending and does not regulate the company's conduct in the private market.' The Hill has reached out to Boehringer Ingelheim for comment. In Texas, Senior U.S. District Judge David Alan Ezra dismissed the lawsuit brought forward by the trade group PhRMA with prejudice, closing the case. As in Connecticut and other cases challenging Medicare negotiations, Ezra noted that drugmaker participation in Medicare is entirely voluntary. Ezra stated that because of the voluntary participation, drugmakers do not have a protected interest to sell drugs to Medicare at their preferred 'fair market value.' He similarly found that the plaintiffs had failed to demonstrate that they will suffer irreparable harm due to negotiating drug prices and was unconvinced of claims that the program violated the plaintiffs' Fifth and Eighth Amendment rights. 'In sum, Plaintiffs cannot demonstrate that the Program deprives them of a protected interest and therefore their Due Process Clause claim fails as a matter of law,' wrote Ezra, granting the federal government's request for summary judgment. The Hill has requested comment from PhRMA. These decisions come just one day after a federal judge upheld a ruling to dismiss a similar challenge to Medicare negotiations brought forward by the U.S. Chamber of Commerce. The courts found that several of the plaintiffs attached to the case lacked standing to sue. Merith Basey, executive director of the advocacy group Patients For Affordable Drugs, lauded the rulings in a statement Thursday. 'Once again, a drug company brought its high-priced lawyers to lay out its arguments against Medicare negotiation, and once again they have lost. This ruling against Boehringer Ingelheim marks the fifth consecutive legal victory for patients who have long awaited relief from Big Pharma's monopoly control over drug prices,' said Basey. 'It's truly US v Big Pharma. Patients For Affordable Drugs stands firm in our commitment to defending the hard-won Medicare negotiation program against Big Pharma's relentless attempts to undermine it at the expense of patients,' she added.
Yahoo
5 days ago
- Business
- Yahoo
This Blue-Chip Stock Is Cooking Up a Major Growth Catalyst
Eli Lilly and Company (LLY), one of the world's leading pharmaceutical giants, might have just unveiled its next major growth catalyst — one that could significantly bolster its dominant position in the highly competitive diabetes market. Last Thursday, Lilly announced encouraging results from a landmark study showing that its blockbuster diabetes medication, Mounjaro, delivers cardiovascular benefits comparable to traditional heart medications. This breakthrough could not only expand Mounjaro's prescribing potential, but also accelerate the company's momentum. With cardiovascular diseases representing one of the leading risks for patients with Type 2 diabetes, doubling their likelihood of experiencing heart attacks or strokes, this development positions Mounjaro to become physicians' top choice for a massive patient population. As the company prepares to submit the heart health data to global regulators by year-end, the path is set for potential regulatory approval and favorable insurance coverage as early as 2026. More News from Barchart Supermicro's Earnings Selloff Explained: Should You Buy SMCI Stock Now? Amazon's $36M Bet on Quantum Computing: What Investors Need to Know AMD Stock Slips After Q2 Earnings, But Here's Why It's a Buying Opportunity Tired of missing midday reversals? The FREE Barchart Brief newsletter keeps you in the know. Sign up now! In this article, we'll delve deeper into Eli Lilly's recent announcement, unpack its strategic implications, and explore why investors should closely monitor this blue-chip pharmaceutical stock as it cooks up this potentially game-changing growth catalyst. About Eli Lilly Stock Eli Lilly and Company (LLY) is a leading global pharmaceutical firm specializing in the discovery, development, and marketing of a broad portfolio of medications. The company has a strong presence in key therapeutic areas, including diabetes, oncology, immunology, and neuroscience. Its product portfolio features well-known diabetes treatments such as Basaglar, Humalog, Jardiance, Mounjaro, Trulicity, and Zepbound, which also target obesity. LLY has a market cap of $707 billion. Shares of the drugmaker are down 17.3% in the year to date. Although LLY stock started the year on an upbeat note, climbing to highs above $900, concerns over healthcare reform, tariffs, and a slowing economy eventually drove it down. Last Thursday, U.S. President Donald Trump sent letters to 17 major pharmaceutical firms, including Eli Lilly, urging them to reduce drug prices for U.S. consumers. Also, Trump said on Tuesday that U.S. tariffs on pharmaceutical imports would be announced 'within the next week or so.' LLY Stock Plunges as Weight-Loss Pill Trial Disappoints LLY shares are down more than 14% at the time of writing after the company reported disappointing late-stage trial results for its experimental obesity pill, overshadowing strong quarterly results. The company said that in a Phase 3 trial, patients taking a 36-milligram dose of its oral GLP-1 drug, orforglipron, without food or water restrictions, experienced an average weight loss of 12.4%, equivalent to 27.3 pounds, over 72 weeks. That falls short of the 15% average weight loss seen with Novo Nordisk's (NVO) injectable Wegovy. It also misses Wall Street's expected range of 12% to 14%, according to analysts at HSBC. Equally important were side effects, as nearly 25% of patients on the highest dose withdrew from Lilly's study, according to Jared Holz, a healthcare strategist at Mizuho Securities. Investors are looking for a 'more well-tolerated drug,' he said, emphasizing that the pill could be used as 'more of a consumer product.' Weight-loss pills represent the next key battleground in the obesity market, and investors had believed Lilly held an edge over Novo. However, the latest data have cast doubt on Lilly's claim to market leadership. Meanwhile, unlike Novo, which recently trimmed its growth forecast due to headwinds in the GLP-1 market, Eli Lilly raised the midpoint of its full-year revenue guidance by $1.5 billion to a range of $60 billion to $62 billion. In an interview, Lilly CEO David Ricks stated that the company wasn't disappointed with the results, even though they came in 'one or two points below what [the] Street had' expected. Ricks added that the goal was to create a pill that was easy to take, scalable for mass production, and delivered weight loss results comparable to other GLP-1 treatments, 'and that's what we've achieved.' While investors are underwhelmed with today's news, Lilly still has more in its pipeline, so let's take a closer look at one of its potential upcoming growth catalysts. Eli Lilly's Mounjaro Makes Cardio Advance Last Thursday, Eli Lilly announced that its top-selling diabetes drug, Mounjaro, demonstrated heart health benefits in a late-stage trial that directly compared it to the company's older treatment, Trulicity. Mounjaro achieved the study's primary objective by proving it was not inferior to Trulicity in treating patients with Type 2 diabetes and established cardiovascular disease. Notably, the study involved over 13,000 patients with Type 2 diabetes and heart disease across 30 countries and spanned approximately four and a half years, making it the largest and longest clinical trial to date on tirzepatide, the active ingredient in Mounjaro. The study revealed that patients taking Mounjaro had a 16% lower mortality rate compared to those on Trulicity. Also, patients on Mounjaro had an 8% lower risk of cardiovascular death, heart attack, or stroke compared to those taking Trulicity. In addition, Lilly said that patients on Mounjaro experienced greater improvements in blood sugar levels, weight loss, and blood pressure. The most frequently reported side effects for both drugs were mild and related to the gastrointestinal system. The results come at a time when Trulicity, another top-selling Eli Lilly drug, is approaching patent expiration in 2027, potentially strengthening Mounjaro's position in the diabetes market. They were strong enough for Mounjaro to meet the predefined statistical threshold for non-inferiority compared to Trulicity, but it fell short of the higher bar for superiority, disappointing some investors and causing the stock to drop 2.6%. Some clinicians noted that the results, especially the reduced risk of cardiovascular events, weren't surprising, as they had expected Mounjaro to provide cardiovascular benefits. However, the difference in all-cause death rates between Mounjaro and Trulicity is 'really quite profound' and 'definitely something clinically meaningful to us as clinicians,' according to Dr. David Broome, clinical assistant professor at the department of internal medicine's metabolism, endocrinology, and diabetes division at the University of Michigan. Tirzepatide, the active ingredient in Mounjaro and Zepbound, which Lilly markets for weight loss, has quickly emerged as one of the pharmaceutical industry's fastest-selling drugs. It has already established itself as a leading treatment option for Type 2 diabetes and obesity. In Q1, Mounjaro sales more than doubled to $3.8 billion, while Zepbound, still in the early stages of its launch, generated an impressive $2.3 billion, highlighting strong demand. In Q2, Mounjaro sales increased 68% to $5.2 billion and Zepbound sales nearly tripled to $3.4 billion. And the latest study is especially important to Lilly's efforts to expand tirzepatide's dominance, given the close connection between diabetes, obesity, and cardiovascular risk. Lilly stated that it believes the new data strengthens the case for making Mounjaro the top prescribing choice for patients with Type 2 diabetes, who face twice the risk of heart disease or stroke compared to those without the disease. Eli Lilly is set to present the study at a medical conference in September. The company intends to submit the heart health data to global regulators by year-end and noted that this could lead to approvals of Mounjaro for this purpose in 2026, potentially improving insurance coverage and boosting prescriptions. More precisely, Lilly aims to expand Mounjaro's label to include an indication for cardiovascular risk reduction. 'These findings strengthen the case for Mounjaro as a potential front-line treatment for people with type 2 diabetes and cardiovascular disease,' Ken Custer, president of Lilly's cardiometabolic business, said in a statement. Success is expected to strengthen Lilly's position against Novo Nordisk's rival GLP-1 drug, semaglutide, which the Danish pharmaceutical company markets as Ozempic for diabetes and Wegovy for weight loss. Novo has already demonstrated that both Ozempic and Wegovy lower the risk of heart attacks and strokes in patients with obesity and diabetes. Both drugs include labeling that highlights these benefits, giving Novo a competitive edge in coverage negotiations with insurers and government programs. What Do Analysts Expect for LLY Stock? Despite LLY's underperformance this year, Wall Street analysts remain highly bullish on the stock, as evidenced by its consensus 'Strong Buy' rating. Out of 26 analysts covering the stock, 20 rate it a 'Strong Buy,' two suggest a 'Moderate Buy,' and the remaining four recommend holding. The average price target for LLY stock is $984.29, indicating solid upside potential of 53% from current levels. On the date of publication, Oleksandr Pylypenko did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on Fehler beim Abrufen der Daten Melden Sie sich an, um Ihr Portfolio aufzurufen. Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten
Nikkei Asia
20-06-2025
- Business
- Nikkei Asia
German drugmaker Boehringer eyes Japan as Asia hub with $346m investment
TOKYO -- German drugmaker Boehringer Ingelheim plans to invest a total of 300 million euros ($346 million) in its plant in Japan from 2023 to 2028 as it moves to make the facility a production base for Asia and Oceania. The plant, in the country's northeastern prefecture of Yamagata, currently produces the diabetes and kidney disease treatment drug Jardiance, mainly for the domestic market.
Mint
12-06-2025
- Health
- Mint
These diabetes drugs are finding new life as an antiaging hack
Some health-obsessed Americans believe the next antiaging therapeutic already exists—in the medicine cabinets of millions of diabetes patients. The widely used class of drugs, called SGLT2 inhibitors and sold under brand names such as Jardiance and Farxiga, have been on the market for over a decade as Type 2 diabetes medications. They have also gained regulatory approval to treat conditions like heart failure and kidney disease. Recently, though, the drugs have emerged as a hot topic on popular health podcasts and Reddit forums for longevity enthusiasts, many of whom don't suffer from any of those conditions. Instead, they are adding SGLT2 inhibitors to a roster of hacks they hope will help them live healthier for longer—or in other words, increase their healthspan. The drugs work by helping the kidneys release extra glucose from the body through urine, improving blood-sugar levels. While there are no studies of whether they can extend the lives of healthy humans, a growing body of evidence shows they help protect against multiple age-related diseases and reduce mortality rates for patients with certain chronic conditions. Some researchers believe they may also affect the fundamental biology of aging. 'This is probably the drug class of our era," says Dr. Timothy Gong, section physician leader for heart failure and transplant cardiology at Baylor University Medical Center, who has researched SGLT2 inhibitors. 'You see cardiologists, nephrologists, endocrinologists, even general internists as well, just getting so excited." Gong says he wouldn't be surprised to take an SGLT2 inhibitor one day, once they are studied more, though he's free from heart issues and diabetes. Yet it's too early to prescribe it for longevity benefits in otherwise healthy patients. 'I don't think that the evidence is strong enough yet for us to be able to say that," he says. Right now, use of SGLT2 inhibitors for potential antiaging benefits is limited mostly to a growing community of so-called biohackers, who seek to optimize their health through experimentation with gadgets, behaviors and various medicines and supplements. Because most take it off-label—meaning, for a nonapproved use—the drugs typically aren't covered by insurance and can cost hundreds of dollars a month out of pocket. Dave Aiello, a Boston chiropractor who doesn't have diabetes, began experimenting with the drugs after learning about a promising study in mice. The 38-year-old wanted to get ahead of health problems but was disenchanted by what he saw as a reactive approach to disease in conventional medicine. 'I'm trying to see if I can just stay as healthy as possible for as long as possible," says Aiello, who has been taking an SGLT2 inhibitor called empagliflozin since 2022. He also takes the kidney-transplant drug rapamycin off-label and has previously taken the diabetes pill metformin—both of which have gained traction as potential longevity boosters, too. He was particularly impressed by research showing SGLT2 inhibitors can help the body manage blood sugar more efficiently, which in turn supports cardiometabolic health. He says he's encouraged by the results so far: Between 2022 and 2024, Aiello's hemoglobin A1C, a measure of average blood sugar, fell to 4.6% from 5.1%, his laboratory test results show. The drugs aren't free of potential side effects, including increased risk of urinary-tract infections, dehydration, and in rare cases, severe genital infections and a life-threatening condition called diabetic ketoacidosis. When Aiello first started taking empagliflozin, he felt dehydrated and experienced fatigue and brain fog. Those side effects have subsided since he decreased his dose and has made sure to take in more electrolytes. 'I'm a little more willing to take some risks that could potentially affect me in the short term if I do think that there might be a benefit," Aiello says. It isn't clear precisely how SGLT2 inhibitors might protect against the ravages of aging, but the research in mice offers clues. In 2020, a National Institute on Aging-funded study found that one SGLT2 inhibitor called canagliflozin extended the lives of male—but not female—mice by 14%. One theory is that the drugs help slow the aging process partly by blunting blood-sugar spikes. Scientists say that by driving insulin levels down, these drugs promote fat burning and create an anti-inflammatory effect that mimics calorie restriction, which studies suggest can slow the pace of aging. Still, many drugs that work in mice don't work in humans, says Richard A. Miller, who led the study and is director of the Glenn Center for Biology of Aging Research at the University of Michigan. His lab is now studying how the small molecules inside slow-aging mice change over time. If a drug in humans produces these same metabolomic shifts seen in slow-aging mice, he says, it would provide more confidence that it could slow aging in people. 'We still have a lot of work to do to prove that the drugs do the same thing in people," says Miller. 'The hint here is that it's actually slowing the aging rate." Alan Vuong, who works in sales in Austin, Texas, started taking the SGLT2 inhibitor dapagliflozin this year after hearing a podcast interview with Miller. The 34-year-old has a family history of Type 2 diabetes and wanted to lower his fasting insulin level, a measure of metabolic health, from normal to optimal. He spends about $150 a month on his longevity protocol, which includes a dozen drugs and supplements, and has seen his insulin levels drop since starting the medication. Other than having to use the bathroom in the middle of the night more often, a known side effect of the drugs, Vuong hasn't noticed other physical side effects. 'My end goal is to extend lifespan, but more importantly, healthspan," he says. 'I'm willing to take that gamble."
Chicago Tribune
02-06-2025
- Business
- Chicago Tribune
AbbVie partners with Chicago Cubs to fund cancer research; ‘We aim to create greater awareness for cancer advocacy'
AbbVie may be known to many people for its medicines like Jardiance, Rinvoq and Skyrizzi, through their television commercials, but in laboratories in a building on its 70-acre North Chicago campus a group of scientists is on the cutting edge of cancer treatment. Though there is an emphasis on blood cancers, Andy Souers, AbbVie's vice president heading oncology discovery research, said the scientists are also trying to find treatments that work for ovarian, lung and colorectal cancers, among others. Working meticulously over sometimes long periods of time, looking at human cells and the molecules within them, Souers said the scientists look for ways to kill the malignant cells to improve a patient's condition. 'We take white cells out of the body to help find ways of curation,' Souers said. 'We look for ways we can just kill the tumor cells.' As Souers and his colleagues in AbbVie's labs work to find more solutions to treat cancer, the company is increasing its awareness campaign for cancer advocacy, including a partnership with the Chicago Cubs announced Friday, which could put thousands of dollars toward treating cancer. Dubbed 'Striking Out Cancer,' for every strikeout a Cub pitcher throws during the 2025 home season starting last Friday, AbbVie will donate $233 to Cub Charities, according to an AbbVie press release. The $233 amount is in honor of the 233 Americans diagnosed with cancer every hour. 'Together with our hometown partner, the Chicago Cubs, we aim to create greater awareness for cancer advocacy and to make a remarkable impact for those living with cancer worldwide,' Tracie Haas, AbbVie's senior vice president for corporate affairs, said in the release. In the Cubs' three games over the weekend. the team's pitchers struck out 18 batters netting nearly $5,000 to fight cancer. With 63 home games left this season, the donation could approach more than $100,000. While the Cub pitchers are doing their part, AbbVie's scientists continue to look for more ways to snuff out cancerous cells. Other people at the company are doing their part, getting the medicine to the patients who need it. Lung cancer is a serious concern and receiving a lot of emphasis from AbbVie because, Souers said, it is one of the deadliest. The five-year survival rate is less than 10%, creating an urgency in the lab. 'It's a small cell and that makes it very, very hard,' Souers said. 'Our goal is to dose the patient. Once we have something which works, we go to the next generation of the medicine.' In the labs, people and machines are working together to test and retest potential medicines until they work. Emily Faivre, a senior principal research scientist working in the labs devoted to finding effective medicine to treat cancer, said the testing is rigorous before the approval process even starts. Holding a 2½-inch-by-four-inch specimen container with 384 wells — it's like a honeycomb from a beehive — Faivre said each well receives a drop of material for testing through laboratory equipment. 'It reads enzyme activity,' Faivre said. 'The molecules are very small. We need to know how many we need to kill a cancer cell.' Once the medicine is created and completes the regulatory process, with the U.S. Food and Drug Administration as well as similar agencies in other countries around the world, Brian Anderson deals with the logistics of getting it to other nations. Anderson, AbbVie's vice president of product development for science and technology, said the company has established two distinct supply chains. If there is a problem with one, the other can pick up the slack while the issue is resolved. It assures a patient will get their life-saving drug. 'We supply these medicines to 175 countries around the world,' Anderson said. 'We are doing this on a fairly large scale. Thousands of people need this product.'
