Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. “CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Giving more individuals valuable ...
On February 26, Liu Jingzhen, Secretary of the Party Committee and Chairman of Sinopharm, and his delegation visited the University of Macau, where the two sides signed a strategic cooperation framework agreement and held talks on further deepening cooperation. President of the University of Macau Mr. Song Yonghua, Vice President Mr. Xu Jian, Vice President of Sinopharm Mr. Hu Jianwei, Vice President of Sinopharm Mr. Dong Zenghe, Vice President of Sinopharm and Vice President of Sinopharm Mr. Jin Bin attended the event. Before the meeting, the two sides held a signing ceremony for the strategic cooperation framework agreement, in which Sinopharm’s Vice General Manager Dong Zenghe and University of Macau’s Vice President Xu Jian signed the agreement on behalf of the two sides. Mr. Liu Jingzhen, Chairman of the Board of Directors of Sinopharm, introduced Sinopharm’s innovative development strategy and the key work it has done to help the development ...
The non-invasive tool can also improve patient stratification and monitor disease progression Researchers from King’s College London (KCL) have developed a deep learning framework for a non-invasive brain-age prediction tool for the early diagnosis of neurological diseases. The study built and made available a set of models for clinical use after training multiple brain models from a variety of magnetic resonance image (MRI) types. Neurological disorders, such as Alzheimer’s disease, strokes, multiple sclerosis and Parkinson’s disease, are conditions that affect the brain as well as the nerves found throughout the human body and spinal cord. By comparing patients’ brain ages against their chronological ages, numerous neurological and psychiatric conditions can be identified, helping to predict future health outcomes for patients. Researchers collected over 81,000 patients’ head MRI examinations from Guy’s and St Thomas’ NHS Foundation Trust and King’s College Hospital NHS Foundation Trust between 2008 and 2019. After pre-training models, ...
The conventional methods for measuring free cortisol, the body’s stress hormone, from blood or saliva are quite demanding and require sample processing. The most common method, therefore, involves collecting urine over several days. However, this method requires great perseverance from patients, as collecting every drop of urine over several days can be nearly impossible, even if the patients are hospitalized. This often leads to up to 60% variation in urine-free cortisol measurements in individual patients. Now, researchers have developed a new method for measuring cortisol levels directly from a blood sample, marking a significant advancement in the diagnosis and treatment of various diseases. Researchers from Aarhus University (Aarhus, Denmark) have discovered a groundbreaking method for measuring levels of free cortisol directly from a blood sample. This new method is simple and quick, requiring only a few drops of blood. This contrasts sharply with current practices, which are both cumbersome and ...
Pancreatic cancer ranks as the third leading cause of cancer-related deaths, primarily due to its late detection. Early discovery of the disease, while it’s still treatable, could significantly impact survival rates. For more than a century, scientists have sought to link cancer with cellular energy production and metabolism. The advent of quantitative mass spectrometry has enabled the testing of many such theories. Now, for the first time, researchers have utilized targeted mass spectrometry to demonstrate that pancreatic cancer stems from changes in cellular metabolism that are detectable using a simple blood test. This method could lead to more precise and earlier diagnoses of pancreatic cancer than currently possible with tumor markers or imaging techniques, potentially paving the way for more timely and appropriate therapeutic interventions. In contrast to genomic approaches that measure DNA for early detection and often struggle with false positives and negatives, mass spectrometry can measure extremely low ...
Don Tracy, Associate Editor Teens to be included in both placebo and open label studies for QRX003, a potential treatment for Netherton syndrome. Today, Quoin Pharmaceuticals announced that the FDA has given approval to include teenagers aged 14 years and older in two ongoing clinical trials for QRX003, a potential treatment for Netherton syndrome (NS). According to a press release, this marks the first time that teen patients with NS will have the opportunity to participate in clinical trials under an Investigational New Drug Application (IND). Additionally, the studies will accommodate teens currently on off-label systemic therapy, with the focus of generating comprehensive data for QRX003’s development.1 “We are very pleased to announce this exciting development, not just for Quoin’s clinical program, but for the Netherton community as a whole,” said Michael Myers, BSc, PhD, CEO, Quoin, in a press release. “We are frequently petitioned by parents and caregivers that ...
Akero Therapeutics’ preliminary Phase 2b data show that treatment with its MASH drug, efruxifermin, continued to distance itself from a placebo measured at nearly two years of treatment. The latest Akero data build on six-month results reported in 2022. By FRANK VINLUAN Longer treatment with an Akero Therapeutics drug in development for the liver disease MASH led to better results, including improvement in fibrosis, the liver scarring that is a hallmark of the chronic disorder. Metabolic dysfunction-associated steatohepatitis, or MASH, causes deteriorating liver function that can reach the point of requiring an organ transplant. The fibrosis that develops with MASH is classified in four stages. Stage 4, the most severe, is liver cirrhosis. On Monday, South San Francisco-based Akero reported preliminary results at 96 weeks showing that 75% of patients treated with the highest dose of its drug, efruxifermin, showed improvement of at least one stage of fibrosis without worsening ...
For World Hearing Day, marked on 3 March, the World Health Organization (WHO) has released new technical guidance on hearing aid service delivery approaches for low- and middle-income settings. This document is designed to provide practical guidance to countries in developing hearing aid services in areas that lack human resources for assessing hearing, as well as fitting and maintaining hearing aids. The guidance, developed with support from the ATScale Global Partnership for Assistive Technology, is based on the principle of task sharing among specialists and trained non-specialists. It includes two approaches, one targeting adults and the other for children 5 years and over, and is accompanied by resources with tips for healthy ear care practices, use of hearing aids and how to support people living with hearing loss. “Over 400 million people with hearing loss could benefit from using hearing devices. However, less than 20% of these needs are fulfilled,” ...
On February 28, 2010, AbbVie and OSE Immunotherapeutics, an immunotherapeutics company, announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to address serious chronic inflammatory diseases, which is currently in preclinical studies. OSE-230 is a first-of-its-kind monoclonal antibody designed to activate the G protein-coupled receptor (GPCR) target ChemR23, which may provide a novel mechanism for relieving chronic inflammation by regulating macrophage and neutrophil function. Dr. Jonathon Sedgwick, Senior Vice President and Global Head of Discovery Research at AbbVie, said: “This collaboration underscores our commitment to expanding our immunology portfolio, with the ultimate goal of raising the standard of care for patients suffering from inflammatory diseases worldwide. We look forward to applying our expertise in immunology drug development to advance the development of OSE-230. Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, said: “We are pleased to partner with AbbVie, a global leader in the development and commercialization of ...
Around 900,000 people in the UK are affected by the progressive neurodegenerative disease Researchers from University College London (UCL), in collaboration with the University of Cambridge, have revealed that impaired spatial navigation could determine the risk of Alzheimer’s disease (AD) before the onset of symptoms. Published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, researchers used virtual reality (VR) to test the spatial navigation of 100 asymptomatic adults from the PREVENT-Dementia study. Affecting around 900.000 people in the UK, AD is a neurodegenerative disorder that progressively destroys memory, thinking skills and the ability to carry out simple day-to-day tasks. Researchers recruited adults aged between 43 and 66 years who had a hereditary or physiological risk of AD related to either the APOE-ε4 allele gene, a family history of AD or lifestyle risk factors, including low levels of physical activity, who were around 25 years younger than their estimated ...
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