Globally, more than one billion people suffer from a high rate of missed disease diagnosis, highlighting the urgent need for more precise and affordable diagnostic tools. Such tools are especially crucial in ecologically sensitive and resource-limited areas, underscoring the importance of developing solutions that can enhance health outcomes sustainably under limited resources. Metabolic diagnosis is a promising approach but currently faces hurdles related to the suitability of biospecimens and the reliability of analytical tools. At Shanghai Jiao Tong University (Shanghai, China), researchers have developed a new diagnostic method that combines dried serum spots (DSS) with nanoparticle-enhanced laser desorption/ionization mass spectrometry (NPELDI MS). This method enables the rapid and cost-effective diagnosis of various cancers with an accuracy comparable to that of traditional serum tests. Utilizing an eco-friendly and simple protocol, this innovative tool can significantly lower the high percentages of undiagnosed cases in less economically developed regions. For instance, it could ...
Day One Biopharmaceuticals drug Ojemda is now FDA-approved for advanced pediatric low-grade glioma, the most common type of brain cancer in children. The regulatory decision for Ojemda covers a broader swath of patients than a drug combination from Novartis approved for treating this childhood cancer. By Frank Vinluan on April 24, 2024 One quirk of the most common type of pediatric brain cancer is that as a child gets older, the tumors eventually stop growing. The reasons for this tumor senescence aren’t fully understood, but pediatric low grade glioma, or pLGG, still wreaks plenty of havoc until then, says Sam Blackman, a pediatric oncologist and the co-founder and head of R&D for Day One Biopharmaceuticals. “Whether it’s the tumor pressing on an optic nerve creating blindness, damage to the hypothalamus or pituitary gland causing profound endocrine disorders, or pressure on motor structures in the brain causing hemiparesis or loss of ...
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 ...
Questions about whether acetaminophen use during pregnancy can lead children to develop neurological problems have sparked scientific inquiry and litigation. Lawsuits are continuing, but a new National Institutes of Health-sponsored study has results that show no causal link between acetaminophen and neurodevelopmental disorders. By Frank Vinluan When women experience pain or fever during pregnancy, many clinicians recommend acetaminophen for relief. But concerns about a possible link between these medicines and neurodevelopmental disorders have lingered. A multi-year study sponsored by the National Institutes of Health has results that add to the scientific consensus that these medicines aren’t the cause of neurodevelopmental problems. Acetaminophen is the active pharmaceutical ingredient in some prescription products and popular over-the-counter pain relievers, notably Tylenol and Excedrin. While nonsteroidal anti-inflammatory drugs offer an alternative approach to pain relief, these drugs aren’t recommended during pregnancy because they can cause low levels of amniotic fluid among other problems. The ...
Don Tracy, Associate Editor Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio. The FDA has approved Takeda Pharmaceuticals’ subcutaneous (SC) form of Entyvio (vedolizumab) as a maintenance therapy for adults with moderately to severely active Crohns disease (CD) following initial intravenous (IV) induction therapy. The expanded approval for an SC form of the drug was based on results from the randomized, double-blind, placebo-controlled Phase III VISIBLE 2 trial, which evaluated 409 patients who were treated with an injection of Entyvio or placebo every two weeks. At the end of the trial, 48% of patients treated with Entyvio experienced clinical remission.1,2 “Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve ...
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 ...
Vertex Pharmaceuticals’ suzetrigine, previously named VX-548, is steadily advancing along its rolling submission approval pathway okayed by the US Food and Drug Administration (FDA) for moderate-to-severe acute pain. The company announced its plans to submit an NDA following positive Phase III results from two clinical trials investigating the drug in patients who had undergone bunionectomy (NCT05553366) or abdominoplasty (NCT05558410) surgery. Both trials met the primary endpoints, and suzetrigine demonstrated a favourable safety profile with no serious adverse events reported. Vertex has started the rolling submission process and aims to finish by Q2 2024. With FDA fast track and breakthrough therapy designations already secured for the drug to treat acute pain, Vertex is now focusing on neuropathic pain, where positive Phase II results have been achieved. Following a successful end-of-Phase II meeting with the FDA, Vertex is planning a Phase III pivotal programme for patients with diabetic peripheral neuropathy (DPN) later ...
The Tyche model could help clinicians and researchers capture crucial information in images Researchers from the Massachusetts Institute of Technology (MIT), the Broad Institute of MIT and Harvard, and Massachusetts General Hospital have introduced a new artificial intelligence (AI) tool to capture the uncertainty in a medical image. Funded by the National Institute of Health, the Eric and Wendy Schmidt Center and Quanta Computer, the Tyche machine-learning model could help clinicians and researchers capture crucial information. In biomedicine, AI models help clinicians by highlighting pixels that show signs of a certain disease or anomaly. However, these types of models usually only provide one answer. “Having options can help in decision-making” and “so it is important to take this uncertainty into account,” said MIT computer science PhD candidate, Marianne Rakic. Researchers developed Tyche after modifying a straightforward neural network architecture. After feeding the tool a few examples of segmentation tasks, such ...
Mike Hollan The Health Cube will increase remote and virtual care options for populations living in remote areas. AI is helping to expand healthcare solutions to rural areas. While people living in or near highly populated areas tend to have more options when it comes to healthcare, the lack of options in rural areas can be a real issue. For patients living in a state like Alaska, getting access to the proper care can involve traveling long distances, delays in obtaining medication, and sometimes being unable to find the proper specialists. One way that the industry is attempting to solve this issue is by bringing more telehealth and virtual options to these areas. New technologies, such as AI, are making this easier, as the algorithms are better able to match patients with the proper care providers through virtual sessions, while also making it easier to find ways to get the ...
Recently, Chiatai Tianqing Pharmaceutical Group has reached the primary endpoint in the pivotal registration clinical study of Rovadicitinib (TQ05105), a Class 1 innovative drug independently developed by Chiatai Tianqing Pharmaceutical Group, for the treatment of intermediate- to high-risk myelofibrosis (MF). The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration regarding the marketing application for TQ05105 tablets and has obtained the CDE’s consent to submit a marketing application for this product, which will be submitted in the near future. TQ05105 is a JAK/ROCK inhibitor with a new chemical structure developed by the company. In vitro test results show that TQ05105 can effectively inhibit JAK family kinase activity and ROCK kinase activity, and can significantly inhibit the phosphorylation level of STAT3 and STAT5 in cells, thus inhibiting the JAK/STAT signaling pathway conduction and thus exerting anti-tumor activity. The Company announced data from a Phase I ...
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