Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus, which can be life threatening. Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro? On Tuesday, the FDA revealed that it is investigating patient reports of suicidal thoughts and hair loss from the use of the blood sugar-modulating products. The U.S. regulator also is looking into cases of aspiration, a condition often associated with surgery in which people breathe food, liquids, vomit or saliva into their lungs. The investigation was triggered by information gathered on the FDA Adverse Event Reporting System (FAERS), a database that allows the regulator to track potential problems by collecting side effect reports from patients and healthcare providers. Each quarter, the FDA posts a list of drugs that ...
Hearing loss affects approximately 40 million American adults, yet only one in 10 people who need hearing aids use them, research shows. Those who don’t use hearing aids but should may want to make wearing them one of their New Year’s resolutions, according to a new study from Keck Medicine of USC published today in The Lancet Healthy Longevity. Janet Choi, MD, MPH, an otolaryngologist with Keck Medicine and lead researcher of the study said, “We found that adults with hearing loss who regularly used hearing aids had a 24% lower risk of mortality than those who never wore them. These results are exciting because they suggest that hearing aids may play a protective role in people’s health and prevent early death.” Previous research has shown that untreated hearing loss can result in a reduced life span (as well as other poor outcomes such as social isolation, depression and dementia). ...
A novel artificial intelligence (AI) tool, designed to interpret medical images with exceptional clarity, is set to revolutionize the way clinicians approach disease diagnosis and image analysis. This advanced tool, named iStar (Inferring Super-Resolution Tissue Architecture), was developed by researchers at the Perelman School of Medicine at the University of Pennsylvania (Philadelphia, PA, USA). It can assist healthcare professionals in diagnosing and treating cancers that might otherwise remain undetected. iStar offers an in-depth view of individual cells and a broader look at the full range of human gene activity, potentially revealing cancer cells that were nearly invisible earlier. This tool could play a crucial role in confirming whether cancer surgeries have fully removed malignancies and provide automatic annotations for microscopic images, marking a significant leap toward molecular-level disease diagnosis. One of the standout capabilities of iStar is its automatic identification of crucial anti-tumor immune formations known as “tertiary lymphoid structures,” ...
After a dispute over milestone payments derailed a 2019 heart med collaboration, Daiichi Sankyo and Esperion Therapeutics have mended fences with a $125 million settlement. Under the new agreement, Daiichi will pay Esperion $100 million in the coming weeks before an anticipated label expansion in Europe for their bempedoic acid products Nilemdo and Nustendi, which are branded as Nexletol and Nexlizet, respectively, in the U.S. The company will pay a further $25 million in the quarter following the European Medicines Agency’s (EMA) decision on whether to add language about a cardiovascular risk reduction to the drug’s label. Meanwhile, European manufacturing and supply responsibilities will change hands from Esperion to Daiichi, which will deliver “significant cost savings and efficiencies” to both companies, the partners said in a joint press release. Going forward, the two companies will expand their collaboration to potentially work on a triple-formulation product using bempedoic acid. Daiichi will ...
Heart failure (HF) is a complex clinical condition characterized by high mortality rates. Existing methods for assessing the biological complexity of HF and determining clinical strategies are somewhat inadequate. High-throughput proteomics has the potential to enhance risk prediction; however, its practical application in managing HF patients requires robust validation and proven clinical advantages. Now, researchers have developed a new protein risk score that offers improved calibration and the potential to assist healthcare providers in more accurately determining the mortality risk in individuals with HF. Researchers from the National Institutes of Health (NIH, Bethesda, MD, USA) have developed and validated a protein risk score to stratify mortality risk in persons with heart failure using a community-based cohort of 7,289 plasma proteins in 1,351 patients with HF using the SomaScan Assay from SomaLogic (Boulder, CO, USA). In the development cohort, the team chose 38 unique proteins for inclusion in the protein risk ...
Brain and other central nervous system (CNS) cancers are the primary cause of cancer-related deaths in children, ranking as the second most prevalent form of childhood cancer following leukemia. For treating CNS tumors, healthcare professionals traditionally rely on a series of magnetic resonance imaging (MRI) scans to gauge the effectiveness of treatments such as surgery, chemotherapy, and radiation. However, MRI scans have limitations, particularly in detecting microscopic diseases that might signal residual or recurring cancer cells. To bridge this gap, scientists have been on a quest to identify reliable, tumor-specific biomarkers. Prior research in adults has demonstrated that primary tumors release circulating tumor cells (CTCs) into the bloodstream, suggesting that CTCs could serve as dependable biomarkers for CNS tumors. A recent study conducted by researchers at the University of Texas MD Anderson Cancer Center (Houston, TX, USA) aimed to determine the effectiveness of a liquid biopsy tool designed to detect ...
Vaccine immunization has dramatically reduced the morbidity and mortality of invasive bacterial infectious diseases such as bloodstream infections. Although a large number of studies have demonstrated that immune protection requires vaccine-induced antibody production, human beings still lack a clear understanding of the cellular and molecular mechanisms of how vaccines provide immune protection. The current international consensus is that vaccines provide immune protection by activating phagocytes in the spleen and blood circulation to remove pathogens that invade the bloodstream. Recently, Jingren Zhang’s group and Linqi Zhang’s group at Tsinghua University School of Medicine, together with Haifa Zheng’s group at Beijing Minhai Biotechnology Co., Ltd, published a paper in Science Translational Medicine titled “Liver macrophages and sinusoidal endothelial cells The research paper, entitled Liver macrophages and sinusoidal endothelial cells execute vaccine-elicited capture of invasive bacteria, reveals that the liver is the main organ that executes vaccine-elicited immunoprotection, and elucidates the molecular mechanism ...
AIM Bio is gearing up for the imminent launch of its blockbuster products, the 13-valent Pneumococcal Conjugate Vaccine and the 23-valent Pneumococcal Polysaccharide Vaccine. The production lines are ready and preparations are underway for WHO-PQ certification. These super vaccine factories have been designed and constructed according to WHO-PQ standards, fully preparing for the global market, showcasing Emergent’s forward-looking layout and arrangements in the international market. In Emergent’s super vaccine factories, the vaccine production process is monitored in real-time, and batches of vaccine products undergo online review and release. The entire production process is traceable with data records, minimizing human intervention, ensuring the repeatability and consistency of vaccine production, reducing the risk of human error, and lowering the risks of contamination and cross-contamination. The digitization and intelligence have reached a globally leading level. Represented by the workshop for the 13-valent Pneumococcal Conjugate Vaccine in Ningbo, these super vaccine factories designed and ...
A new KFF report analyzed recent trends in Medicaid outpatient prescription drug utilization and spending. It discovered that although there’s been lower utilization of prescription drugs in recent years, Medicaid spending on prescription drugs has increased. By MARISSA PLESCIA Although there’s been lower utilization of prescription medications, Medicaid spending on prescription drugs has increased, a recent report shows. The KFF report relied on 2016 to 2022 State Drug Utilization Data, as well as CMS-64 Financial Management Reports from fiscal year 2017 to fiscal year 2022. It comes as states unwind the continuous enrollment provision, which prevented states from disenrolling Medicaid enrollees during the Covid-19 public health emergency. Because of the continuous enrollment provision, Medicaid and CHIP enrollment reached historic highs, peaking at 94.5 million people in April. This represents an increase of 23.1 million people from 2020. But despite the growth in Medicaid enrollment, Medicaid prescription drug utilization was below ...
On December 21, 2023, Shanghai RAAS received the ‘Acceptance Notification’ from the National Medical Products Administration regarding the clinical trial application for ‘SR604 Injection.’ SR604 Injection is a humanized monoclonal antibody that combines with human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. It is intended for the prophylactic treatment of bleeding in patients with hemophilia A/B and congenital coagulation factor deficiency. Currently, routine prophylactic treatment for hemophilia worldwide involves intravenous injection of blood-derived or recombinant coagulation factors 2-3 times a week. SR604 is intended to undergo a Phase I clinical trial for subcutaneous injection prophylactic treatment every 4 weeks. Some preclinical research findings from this project have already been published in the international hematology research journal Blood in the form of a cover article. As of the disclosed information, there are no products on the global market targeting the same ...
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