By Don Tracy, Associate Editor Data from the SUMMIT clinical trial demonstrated that tirzepatide lowered the risk of negative heart failure outcomes and enhanced symptoms and physical limitations when tested with three different doses. Results from the SUMMIT Phase III clinical trial found that Eli Lilly’s tirzepatide, tested at doses of 5 mg, 10 mg, and 15 mg, showed statistically significant improvements in reducing heart failure with preserved ejection fraction (HFpEF) and obesity, as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS), compared to placebo. According to the company, tirzepatide also demonstrated improved exercise capacity as measured by the 6-Minute Walk-Test Distance (6MWD), reduction in the inflammation marker high-sensitivity C-reactive protein (hsCRP), and a noteworthy mean body weight reduction at 52 weeks.1 “HFpEF accounts for nearly half of all heart failure cases, and in the U.S. almost 60% of those impacted also live with obesity.1,2 Despite ...
Sanofi has announced a significant investment of €1.3bn ($1.4bn) to increase its insulin production capabilities with an expanded facility in Frankfurt, Germany. The facility will cover 36,000m² at Sanofi’s existing BioCampus site and become operational in 2029. Sanofi will execute the project with support from the German national government and the Hesse state government, subject to European Union approval. Sanofi manufacturing and supply global head Brendan O’Callaghan stated: “With this project, we reaffirm our commitment to help diabetes sufferers around the world. “We’re using the long-time expertise of our Frankfurt BioCampus and its highly qualified personnel.” The investment comes in the wake of the German government’s adoption of an official pharma strategy in 2023 to bolster support for pharmaceutical companies. The approach also aids in streamlining approval processes and enhances conditions for research and development within the country. Sanofi Germany chairman Heidrun Irschik-Hadjieff said: “Our planned investment underscores the central ...
NHS Scotland, AstraZeneca (AZ) and the Universities of Glasgow and Dundee have entered into a partnership to accelerate research into treating chronic kidney disease (CKD). The collaboration aims to develop new medicines to slow down the progression of CKD, build infrastructure and enhance expertise in renal clinical trial delivery in Scotland to improve patient outcomes. Affecting nearly 850 million people worldwide, CKD is a serious, progressive condition caused by decreased kidney function, commonly caused by diabetes, hypertension and glomerulonephritis. By preventing the progression of CKD, patients will live longer, better lives, free from other consequences of the condition, including heart failure, cardiovascular disease and stroke, while also reducing pressure on the NHS. In addition to slowing the progression of CKD, NHS Scotland, AZ and the Universities of Glasgow and Dundee will work to reduce the risk of patients potentially needing dialysis, a procedure to remove waste products and excess fluid ...
Scientists have developed an advanced artificial intelligence (AI) approach that can predict the likelihood of developing age-related conditions such as Alzheimer’s and heart disease up to a decade before symptoms manifest. By analyzing blood samples from over 45,000 individuals using machine learning, researchers identified specific protein patterns associated with an increased risk of disease. This capability to predict the probability of developing a health condition before any symptoms are observed could potentially enhance personalized medicine by providing early warnings, thereby opening doors for preventative interventions. Researchers from the University of Edinburgh (Edinburgh, UK) participated in a study that used data from the UK Biobank, which contains genetic and health information from half a million UK participants. They applied AI and machine learning to detect protein patterns in blood that correlate with the onset of common ailments including Alzheimer’s, heart disease, and type 2 diabetes. The analysis was based on medical ...
Dexcom lowered its sales forecast for 2024, surprising Wall Street as it lost market share among durable medical equipment (DME) providers and restructured its salesforce. Shares of the company were down 41% Friday morning. The diabetes device firm now expects 2024 revenue of $4 billion to $4.05 billion, a decrease from its previous forecast of $4.2 billion to $4.35 billion. “We have higher expectations for our business than what we experienced this quarter,” CEO Kevin Sayer told investors on Thursday, adding that he expects “more from myself and more from my team going forward.” Sayer attributed the lower sales outlook to three factors: a salesforce restructuring, lower revenue per customer due to rebates, and a loss of market share in the durable medical equipment channel. Those dynamics put Dexcom’s U.S. revenue about $40 million below the company’s internal estimates, CFO Jereme Sylvain said. The company also had about 70,000 fewer ...
The European Medicines Agency (EMA) has offered a positive opinion to Novo Nordisk, which should pave the way for the company to update the label for its blockbuster weight loss drug Wegovy (semaglutide 2.4mg). The new label will reflect the therapy’s positive effects on cardiovascular health, potentially improving its chances for reimbursement in Europe. Under the new label, healthcare providers will be able to prescribe Wegovy to patients to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with established cardiovascular disease. If approved, this will be available for patients who are overweight or obese (initial BMI ≥27kg/m²) without having diabetes. The EMA’s Committee for Medicinal Products for Human Use (CHMP) supported the label update based on data from the Phase III SELECT (NCT03574597) study. The trial demonstrated that Wegovy decreased the incidence of MACE, in a statistically significant ...
Measuring specific proteins to diagnose conditions like heart attacks, where troponin is tested, is a well-established clinical practice. Now, new research highlights the broader potential of protein measurements from a small blood sample to predict a variety of diseases. In the research, published in Nature Medicine, which was carried out as part of an international partnership involving Queen Mary University of London (London, UK), the investigators used data from the UK Biobank Pharma Proteomics Project (UKB-PPP). This project represents the largest proteomic study to date, analyzing around 3,000 plasma proteins from over 40,000 randomly selected UK Biobank participants. These protein measurements are linked to detailed electronic health records. The researchers applied sophisticated analytical techniques to identify a specific ‘signature’ of 5 to 20 key proteins for predicting each disease. They discovered that these protein ‘signatures’ can predict the onset of 67 different diseases, including multiple myeloma, non-Hodgkin lymphoma, motor neuron ...
Infrared spectroscopy, a method using infrared light to study the molecular composition of substances, has been a foundational tool in chemistry for decades, functioning similarly to a molecular fingerprinting system via a device known as a spectrometer. When utilized on complex biofluids like blood plasma, this physico-chemical technique provides in-depth molecular insights, indicating its potential for medical diagnostics. Despite its established role in chemistry and industry, infrared spectroscopy has yet to become a standard tool in medical diagnostics. To tackle this issue, scientists have developed a diagnostic tool that employs infrared light and machine learning to identify multiple health conditions in just one measurement at the population level. The team from the BIRD group at Ludwig Maximilian University of Munich (LMU, Munich, Germany) had previously worked on methods to measure human plasma. In their most recent study, they introduced infrared molecular fingerprinting to a naturally diverse group, analyzing blood from ...
Roche reported its oral GLP-1 agonist led to an average 6.1% weight loss at four weeks, according to preliminary results from part of a Phase 1 study. The small molecule comes from Roche’s $2.7 billion acquisition of Carmot Therapeutics last year. By Frank VinluanRoche is a relative latecomer to GLP-1 metabolic disorder drugs, but an oral drug candidate that came as part of a $2.7 billion acquisition last year now has preliminary early-stage clinical data that keep the pharmaceutical giant in contention to bring patients a pill to tap into this increasingly popular mechanism for weight loss. The results reported Wednesday are from a Phase 1 test of CT-996, a once-daily pill designed to activate the GLP-1 receptor to treat type 2 diabetes and obesity. Roche said treatment of patients who are obese and do not have type 2 diabetes lost a placebo-adjusted average of 6.1% of body weight within ...
German contract development and manufacturing organisation (CDMO) Corden Pharma announced a €900m ($980m) investment to expand its diabetes drug manufacturing capabilities, as shortages persist around the world. The company declared that the investment would be used over the next three years to expand its peptide manufacturing capabilities at sites in Colorado, US, and Europe. The facilities will have a particular focus on GLP-1 peptide manufacturing, as the demand increases. In a 16 July press release, the company spoke of multiple long-term contracts worth more than €3bn with potential benefits. Last year, the company signed a major deal with Eli Lilly to manufacture the active pharmaceutical ingredient for its leading obesity drug Mounjaro (tirzepatide), as per a Reuters report. In January 2023, the company also shared the signing of a $1bn multi-year agreement to manufacture a large volume peptide with an undisclosed company. The latest investment will be used to construct ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.