Severe acute malnutrition is responsible for nearly half of all child deaths globally and affects 17 million children annually A trial led by researchers at Queen Mary University London, in partnership with two research institutes in Zambia and Zimbabwe, has identified the mechanisms that contribute to the long-term impacts of severe acute malnutrition (SAM) and HIV infection in children. Funded through the Medical Research Council’s (MRC) Global Challenges Research Fund, the study published in Nature Communications aims to identify a treatment to promote the healing of intestinal damage caused by SAM. Affecting around 17 million children every year, predominantly in Africa, SAM and malnutrition are responsible for almost half of all child deaths globally and cause damage to the enteropathy, the small intestine, by reducing its ability to absorb nutrients. The new phase 2 trial, involving 125 children who had been hospitalised due to complications from arising SAM, evaluated four ...
SHANGHAI, April 19, 2024 /PRNewswire/ — GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients. It is the first phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients worldwide, with GFH925 being the first G12C inhibitor that received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for previously treated advanced CRC. GFH925 was also granted BTD and New Drug Application acceptance with Priority Review Designation by NMPA for previously treated advanced non-small cell lung cancer(NSCLC)patients with G12C mutation. The trial (GFH925X0301) will enroll refractory metastatic CRC patients harboring KRAS G12C mutation who have progressed or experienced disease recurrence on or after at least two prior ...
Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50% A new clinical trial being led by the University of Oxford’s Surgical Trial Units in collaboration with NHS Blood and Transplant and five UK lung transplant centres will investigate whether skin patches can be used as an early warning system to detect lung transplant rejection. The SENTINEL trial is being funded by £2m in partnership with the Medical Research Council and the National Institute for Health and Care Research. Lung transplant rejection is commonly monitored through lung function tests, blood tests, X-rays and lung biopsies. However, until it is advanced, lung transplant rejection can be challenging to identify. The new trial aims to investigate the new early warning system to identify early signs of rejection to be rolled out to all lung transplant recipients, cutting rejection by up to 50%. Set to be carried ...
Current strategies for matching cancer patients with specific treatments often depend on bulk sequencing of tumor DNA and RNA, which provides an average profile from all cells within a tumor sample. However, tumors are heterogeneous, containing multiple subpopulations of cells, or clones, each potentially responding differently to treatments. This variability may explain why some patients either fail to respond to certain treatments or develop resistance. Single-cell RNA sequencing offers higher-resolution data than bulk sequencing, capturing data at the single-cell level. This approach to identify and target individual clones may lead to more lasting drug responses, although, single-cell gene expression data are more expensive to generate and less accessible in clinical environments. In a proof-of-concept study, researchers at the National Institutes of Health (NIH, Bethesda, MD, US) have developed an artificial intelligence (AI) tool that leverages data from individual tumor cells to predict how well a person’s cancer might respond to ...
BY SEAN WHOOLEYIceCure Medical (Nasdaq:ICCM) announced today that it submitted final data to the FDA requesting marketing authorization for its ProSense system. Caesarea, Israel-based IceCure designed ProSense to deliver cryoablation that treats breast cancer in a 20-40-minute outpatient procedure. It seeks FDA authorization for treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense already holds FDA breakthrough device designation and has clearance in the U.S. for other indications. Those include treating benign tumors of the breast, and tumors in the kidney and liver. However, the FDA in 2022 denied IceCure’s de novo classification request for ProSense to treat patients with early-stage, low-risk breast cancer. In January of this year, the FDA agreed to reopen the de novo file. An affirmative response from the FDA provided IceCure with a potential pathway to clearance. The company submitted a five-year follow-up dataset from the ICE3 study and ...
Dive Brief Boston Scientific has recalled an agent used to block blood flow to specific vessels due to a safety problem that has been tied to seven injuries and two deaths, the Food and Drug Administration said Wednesday in a recall notice. The company wrote to customers in February to advise against delivering the agent via a commonly used method in some patients because of a risk of reduced blood flow to the bowel. Boston Scientific’s product, Obsidio Conformable Embolic, remains on the market, but the company advised healthcare providers to ensure information on the risk is easily accessible to all users. Dive Insight The solution flows like a liquid when force is applied, and then returns to a soft solid state when the force is removed. As a soft solid, the agent blocks blood vessels. Physicians use the product to block blood supply to tumors with large numbers of ...
Human papillomavirus (HPV) is well-known for its role in causing cervical cancer and is also increasingly identified as being responsible for cancers in the mouth, throat, and other areas of the head and neck. Early detection of cancer is essential, as it greatly improves patient outcomes. Now, a new urine-based test that can detect DNA fragments shed by head and neck tumors could potentially enable earlier detection of these cancers, which currently lack effective screening techniques. The research team at the University of Michigan (Ann Arbor, MI, USA) utilized whole genome sequencing to show that cell-free DNA fragments found in urine, which originate from tumor cells and pass from the bloodstream through the kidneys, are predominantly ultra-short, with less than 50 base pairs. Their small size makes detection difficult using traditional urine or blood-based liquid biopsy tests for circulating tumor DNA (ctDNA). Currently in the experimental stage, this mail-in test ...
Warming the hand is an effective way to facilitate blood collection from a fingertip, yet off-the-shelf solutions often do not fulfill laboratory requirements. Now, a unique hand-warming technology has been specifically designed to enhance the collection of high-quality blood samples from the fingertip. The hand warmer designed to improve the collection of high-quality capillary blood samples has been developed by Babson Diagnostics (Austin, TX, USA) in collaboration with experts in biomedical engineering who study the impact of heat on the human body in the design of therapeutic devices. The Babson Hand Warmer is part of its BetterWay blood testing ecosystem, which combines Babson’s proprietary sample preparation and laboratory technologies with the BD MiniDraw Capillary Collection System. This system is the result of a strategic partnership between Babson and BD (Becton, Dickinson and Company, Franklin Lakes, NJ, USA). Slated for commercial release this year, BetterWay revolutionizes blood testing by requiring just ...
Mike Hollan BrandShield states that it has identified sites selling counterfeit versions of Wegovy and Ozempic, among other drugs. It’s important to always be careful whenever buying anything from a website, especially medication. In recent years, it’s become much more common for patients and other consumers to find online sources where they can directly access medications without having to visit a pharmacy. This provides clear benefits for patients, such as limiting the burden placed upon them and potentially helping to reduce the cost of some medications. As is the case with most things, however, there are also risks. A new report from Reuters details one company’s work to take down sites selling fake medications.1 Not surprisingly, a significant percentage of these sites were selling counterfeit weight-loss drugs, such as fake versions of Ozempic. The report does note, however, that the number of sites selling these counterfeit weight-loss drugs has significantly ...
Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride extended-release capsules, a medication used to treat high blood pressure in the American market due to failed dissolution specifications, informed USFDA in its latest Enforcement Report. The affected lot has been produced in India and is being recalled for “failed dissolution specifications”, the USFDA said. “Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study,” it noted. Glenmark initiated Class II recall of the drug across the US on March 26 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. https://www.business-standard.com/companies/news/glenmark-pharma-recalls-6-528-bottles-of-blood-pressure-drug-in-us-124041400116_1.html
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