Eli Lilly has announced positive top-line results from a late-stage study of its targeted therapy Retevmo (selpercatinib) versus the current first-line standard of care in certain non-small cell lung cancer (NSCLC) patients. The phase 3 LIBRETTO-431 trial has been evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed with or without Merck’s Keytruda (pembrolizumab) as an initial treatment for adults with rearranged during transfection (RET) fusion-positive advanced or metastatic NSCLC. A pre-specified interim efficacy analysis showed that the study met its primary endpoint, with Lilly’s therapy demonstrating a statistically significant and clinically meaningful improvement in progression-free survival. As the company outlined, LIBRETTO-431 is the first randomised study to compare the safety and effectiveness of a targeted therapy to a PD-1 inhibitor plus chemotherapy in cancer patients bearing a specific biomarker. David Hyman, chief medical officer at Loxo@Lilly, said: “The LIBRETTO-431 trial aims to answer an important question about the selection of initial ...
Published in the International Journal of Obesity, University of Minnesota Medical School and School of Public Health researchers led a study on the relationship between dietary intake and cardiovascular disease risk factors. Over 20 years, the research team examined people’s regular dietary intake, paying particular attention to non-nutritive sweeteners commonly found in artificial sweeteners. They found that long-term consumption of aspartame, saccharin, and diet beverages were linked to increased fat stores in the abdomen and fat within muscle. However, the study found no significant association between the artificial sweetener sucralose and these measures of fat volume. Brian Steffen (PhD, MSCR, Professor, Department of Surgery, University of Minnesota Medical School) said, “This study showed that habitual, long-term intake of total and individual artificial sweetener intakes are related to greater volumes of adipose tissue, commonly known as body fat. This was found even after accounting for other factors, including how much a ...
As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users. Case in point is a claim from a Louisiana woman who is suing both companies, alleging her use of Novo’s Ozempic (semaglutide) and Lilly’s Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, who used Ozempic for more than a year and then switched to Mounjaro, says the companies failed to warn patients of “severe gastrointestinal events” that can be caused by using the injected drugs. The lawsuit claims that Bjorklund has suffered from “severe vomiting, stomach pain, gastrointestinal burning,” and has been hospitalized for stomach issues on “several” occasions. The prescribing labels for Ozempic and Mounjaro say the drugs “delay gastric emptying” and warn of the risk of gastrointestinal adverse ...
Researchers at the University of Colorado Anschutz Medical Campus have officially identified a central conduit to obesity: fructose. While fructose’s contribution to obesity is well-known, a study published today in Philosophical Transactions aggregates a large amount of work to make a full argument for how fructose drives obesity and diseases such as diabetes and fatty liver disease. “This is an in-depth review on a hypothesis that puts nature at the center of weight gain, examining how fructose works differently than other nutrients by lowering active energy,” says Richard Johnson, MD, professor at the University of Colorado School of Medicine and study lead author. “We determine a recently discovered function of fructose in survival that stores fuel in case resources become scarce. This is known as the ‘survival switch,'” he says. Fructose is the source of sweetness in fruit, but is primarily consumed in Western society as table sugar and high ...
Hopes around FibroGen’s anemia drug roxadustat were high in early 2020 when Enrique Conterno arrived as the company’s new CEO. He’d just come off a 27-year-run at Eli Lilly and was, according to an analyst interview at the time, “most impressed” by the commercial opportunity for roxadustat.But the last few years have not been kind to FibroGen and AstraZeneca’s drug, with an FDA rejection, commercial disappointments and a clinical trial flop considerably blunting the oral anemia med’s trajectory. It’s against that backdrop—plus a major layoff round—that Conterno, who’s been chief at FibroGen since January 2020, is now hitting the exit. Conterno has resigned from the FibroGen CEO post for “personal reasons,” the company said Tuesday. As FibroGen looks for a permanent successor, the company’s chief commercial officer Thane Wettig will don the mantle of interim chief executive officer. To support Wettig, Conterno plans to stick around as a special advisor to ...
Pictured: Person undergoing an eye exam/iStock, Jacob Wackerhausen Kodiak Sciences shares fell over 50% on Monday after the company announced that its late-stage biologic failed to sufficiently improve the vision of patients with diabetes macular edema and that it would not be pursuing this program any further. The California-based company was testing tarcocimab tedromer, a novel antibody-polymer conjugate developed by the company for the treatment of vision loss. Kodiak had three Phase III trials: DAYLIGHT, GLEAM, and GLIMMER. The DAYLIGHT trial investigated the safety and efficacy of tarcocimab tedromer in a high-intensity dosing regimen for patients with wet age-related amcular degeneration (AMD). Not only was the drug “safe and well tolerated,” but it met the clinical target of “non-inferior visual acuity gains” relative to aflibercept, sold commercially as Eylea and Zaltrap. But the next two Phase III trials, GLEAM and GLIMMER, were far less promising. These were identical studies investigating ...
A pair of new studies presented as abstracts today at the American Society of Nutrition (ASN) annual meeting report that daily prune consumption has promising effects on several biomarkers related to cardiovascular health. Conducted in postmenopausal women and men 55 years and older, the studies reveal: In men, long-term prune consumption improved HDL cholesterol and the total cholesterol to HDL ratio, while decreasing oxidative stress and the inflammatory biomarker C-reactive protein (CRP). In older women, long-term prune consumption had no negative effect on various metabolic measures related to heart disease risk including total cholesterol, total triglycerides, fasting glucose, and insulin levels. The results of both studies were presented at the ASN annual flagship meeting in Boston, MA. The ASN convenes researchers, practitioners, global and public health professionals, policymakers and advocacy leaders, industry, media, and other related professionals to advance nutrition science and its practical application. “Currently, there ...
In one of the first large-scale studies of genes related to diet, researchers have uncovered almost 500 genes that appear to directly influence the foods we eat. The findings represent an important step toward using a person’s genetics to develop precision nutrition strategies that help improve health or prevent disease. “Some genes we identified are related to sensory pathways—including those for taste, smell, and texture—and may also increase the reward response in the brain,” said research team leader Joanne Cole, Ph.D., assistant professor in the Department of Biomedical Informatics at the University of Colorado School of Medicine. “Because some of these genes may have clear paths toward influencing whether someone likes a food or not, they could potentially be used to create sensory genetic profiles for fine-tuning a person’s dietary recommendations based on foods they like to eat.” For the study, the researchers used the UK ...
Black patients with implantable cardioverter defibrillators (ICDs) have a significantly higher burden of disease than white patients with the same device, according to a new study from University of Rochester Medical Center (URMC) cardiology researchers. Analyzing data from clinical trials conducted over a 20-year period by the Clinical Cardiovascular Research Center (CCRC) at URMC, investigators concluded that not only did Black patients with ICDs tend to be significantly younger than white patients, but they also had a higher rate of post-implant cardiac events and risk of death. When a patient is at risk for cardiac arrest, an ICD helps to monitor their heart rhythm, and if an abnormality is detected, the device delivers a shock of electricity to reset the heartbeat to a normal rhythm. The study, published in Circulation, examines the rate of events that a patient experiences after their ICD is implanted. After three years of ...
Eli Lilly on Friday said it will acquire Versanis, a privately held obesity drug maker, for up to $1.93 billion to boost the pharmaceutical giant’s weight loss treatment portfolio. Eli Lilly agreed to pay Versanis shareholders in cash, which will consist of an upfront payment and potentially subsequent payments if Versanis achieves certain “development and sales milestones.” Oakland, California-based Versanis, which was founded in 2021 by biotech investment firm Aditum Bio, has one experimental drug for obesity and potentially other conditions. Eli Lilly’s stock price rose 3% on Friday following the announcement. The deal is Eli Lilly’s latest attempt to capitalize on the weight loss industry gold rush, which began last year after Novo Nordisk’s blockbuster injections Wegovy and Ozempic boomed in popularity. An estimated 40% of U.S. adults are obese. Analysts project that the global weight loss drug market could be worth $100 ...
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