Search Results for “EC” – Page 216 – media

FDA Grants Priority Review to Novartis’ Scemblix for Newly Diagnosed Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

By Don Tracy, Associate Editor Results from the ASC4FIRST study lead to FDA priority review designation of Scemblix in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Blood cell red 3d background vein flow platelet wave cancer medicine artery abstract. Red cell hemoglobin blood donate anemia isolated plasma leukemia donor vascular system anatomy hemophilia vessels. Image Credit: Adobe Stock Images/Five Million StocksThe FDA has granted priority to review to Novartis’ Scemblix (asciminib) for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP). According to the company, the designation was based on promising results from the Phase III ASC4FIRST trial, in which Scemblix showed superior major molecular response (MMR) rates compared to current standard-of-care (SoC) tyrosine kinase inhibitors (TKIs), such as imatinib, nilotinib, dasatinib, and bosutinib.1 “We welcome the FDA’s decision to grant Priority Review and Breakthrough Therapy designations to ...
- Source: drugdu
- 66
- August 2, 2024
PharmaLab Japan

Organiser：Reed Exhibitions Time：July 9-11, 2025 address： 3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall：Tokyo Big Sight International Exhibition Center Product range: General Exhibition Area: Cell biology-related products, drug research-related products, various equipment, consumables, reagents, bioinformatics-related products, bioimaging equipment, software, databases, biological resources, biomaterials, biotech clusters, investment, industrial upgrading, etc. Regenerative Medicine Research Area: Cell culture, cell production products/services, regenerative medicine, cellular medicine, etc. Contract Services Area: Contract research and development (CRD), testing, analysis, contract expression, synthesis, refinement, clinical research CMO, CRO, SMO, technology transfer TLO, IP consulting, etc. Precision Processing Area: Precision/fine processing technologies, micro-chemical engineering (microTAS, Bio MEMS, biochips, biosensors), microchannels, microsystems, etc. About PharmaLab Japan： PharmaLab Japan is one of Asia’s leading exhibitions for pharmaceutical laboratories. With 250 highly anticipated conferences/seminars, it offers attendees the best platform to learn about life sciences. As a comprehensive biotechnology exhibition, it is widely recognized in the industry and brings together ...
- Source: drugdu
- 104
- August 2, 2024
Blood Test Predicts Alzheimer’s Disease with Over 90% Accuracy

Alzheimer’s disease impacts one in five women and one in ten men over their lifetimes, yet diagnostic tools are still often cumbersome and not widely accessible in primary care settings. Although specialized memory clinics frequently use advanced diagnostic methods like PET scans and cerebrospinal fluid tests, there is a significant need for simpler, quicker diagnostic tools that can be used in primary care. Now, a commercially available blood test for Alzheimer’s has demonstrated approximately 90% reliability in primary care settings, representing a major development for individuals seeking assistance for memory loss and suspected of having this neurological disease. Research on this innovative blood testing method, which evaluates levels of Plasma Phospho-Tau217, commenced in 2019 with studies showing that the blood test can detect Alzheimer ‘s-related changes even before symptoms appear and monitor the disease’s progression. Earlier this year, results indicated that this blood test is as reliable as, and ...
- Source: drugdu
- 108
- August 1, 2024
Study finds 3D-printed blood vessels could improve heart bypass outcomes

Coronary heart disease is the most common form of heart and circulatory disease Researchers from the University of Edinburgh, in collaboration with Heriot-Watt University, have revealed that artificial blood vessels printed using novel 3D printing technology could transform the treatment of cardiovascular diseases (CVD). The findings published in Advanced Materials Technologies demonstrate that artificial blood vessels could improve outcomes for heart bypass patients. CVD affects around seven million people in the UK and is a significant cause of disability and death. Heart bypass surgery is a procedure used to treat coronary heart disease, the most common form of heart and circulatory disease that affects around 2.3 million people in the UK. It occurs when coronary arteries become narrowed by a build-up of fatty material within their walls. Researchers led by the University of Edinburgh’s School of Engineering used a rotating spindle integrated into a 3D printer to print tubular grafts made from ...
- Source: https://pharmatimes.com/news/study-finds-3d-printed-blood-vessels-could-improve-heart-bypass-outcomes/
- 111
- August 1, 2024
Fosun PharmaceuPharmacopeia as an Official Control Product

On July 23, 2024, Guilin Nanopharm received a letter from the United States Pharmacopeial Convention (hereinafter referred to as USP) “Donation Recognition Program Team”, which mentioned that the artesunate control product donated by Guilin Nanopharm has been listed as an official control product by USP. Artesunate is the original anti-malarial drug developed by Guilin Pharmaceuticals for the secondary research and development of artemisinin. It solved the problem of water solubility of artemisinin and obtained the certificate of Class I New Drug No. X-01 issued by the Ministry of Health of China in 1987. The control of Artesunate was calibrated by Guilin Southern Pharmaceuticals and USP official laboratories respectively, and the content determination results were identical, both were 99.8%. The data of infrared, mass spectrometry, nuclear magnetic resonance (NMR), related substances, moisture and other assays showed complete match. The inclusion of this control as an official control by USP ...
- Source: drugdu
- 80
- August 1, 2024
【EXPERT Q&A】How to build the quality management system of aseptic IVD for medical devices?

Drugdu.com expert’s response: The establishment of a quality management system (QMS) for sterile in vitro diagnostic (IVD) medical devices is a complex and systematic process aimed at ensuring product safety, effectiveness, and compliance with regulatory requirements. Below is a detailed, professional step-by-step approach, referencing the Medical Device Manufacturing Practice and relevant regulatory mandates: I. Define Quality Policy and Objectives 1.Establish Quality Policy: The enterprise shall articulate a quality policy that embodies its commitment to medical device quality and patient safety. 2.Set Quality Objectives: Based on the quality policy, set specific, measurable quality objectives, such as product conformity rates and customer satisfaction levels. II. Establish Organizational Structure and Responsibilities 1.Setup Management Organization: Create a management structure tailored to medical device production, clearly defining the responsibilities and authorities of each department. 2.Appoint Management Representative: The corporate leader should designate a management representative responsible for establishing, implementing, and maintaining the QMS. 3.Clarify Responsibilities and Authorities: ...
- Source: drugdu
- 74
- July 31, 2024
Silicon Chip Based Blood Test Rapidly Diagnoses Patients with Hypothyroidism

Hypothyroidism impacts about 10% of the U.S. population, making the Thyroid Stimulating Hormone (TSH) test the most frequently conducted immunoassay in the United States. Traditional testing often involves significant time commitments for patients, including visits to labs and waiting 2 to 5 days for results. Now, a new TSH immunoassay performed on a silicon chip delivers results in approximately 30 minutes. Genalyte (San Diego, CA, USA) has received U.S. Food and Drug Administration (FDA) approval for its groundbreaking immunoassay, the first of its kind to be cleared for use on a silicon chip-based device. The Maverick Diagnostic System (MDS) incorporates silicon chip-based photonic ring resonator technology, enabling the execution of multiple rapid tests simultaneously from a small sample of whole blood or serum. This system is also connected to the cloud, facilitating the retrieval of assay protocols and enabling clinical oversight. Genalyte’s innovation effectively minimizes the traditional bulky lab machinery ...
- Source: drugdu
- 94
- July 31, 2024
Study reveals blood proteins predict risk of developing many diverse diseases

Researchers predicted the onset of 67 diseases, out-performing current standard models A study conducted in partnership between University College London (UCL), GSK, Queen Mary University of London, Cambridge University and the Berlin Institute of Health at Charité Universitätsmedizin, Germany, has revealed that proteins in the blood could predict the onset of many diverse diseases. The findings published in Nature Medicine could offer new prediction possibilities to treat and diagnose a wide range of diseases, including multiple myeloma, non-Hodgkin lymphoma, motor neurone disease, pulmonary fibrosis and dilated cardiomyopathy. Utilising the UK Biobank Pharma Proteomics Project, researchers used data linked to electronic health records of 3,000 plasma proteins from a randomly selected set of over 40,000 participants. Using advanced analytical techniques to measure thousands of proteins in a single drop of blood, researchers pinpointed each disease between the five and 20 proteins most important for prediction to predict the onset of 67 ...
- Source: drugdu
- 69
- July 31, 2024
New gut microbiome atlas could offer better treatment for digestive disorders

The new Human Gut Microbiome Atlas could help treat conditions including IBS and AMR Researchers from King’s College London (KCL) have developed a new gut microbiome atlas in collaboration with MetaGenoPolis and the Science for Life Laboratory to help better understand how microorganisms in the gut impact disease. Published in Genome Research, the Human Gut Microbiome Atlas, which identifies gut bacteria in people with 23 separate diseases across 19 countries, could lead to more effective treatments for conditions such as inflammatory bowel disease (IBS). The human gut microbiome provides an individual profile of bacteria and other microorganisms that live in the gut, which helps perform key bodily functions, including digestion. However, fragmented data existing on the genetic makeup of individual microbes in the gut has prevented large-scale comparative studies and doctors from tailoring treatment to work with the specific microbiome of patients. After performing a survey of genetic data from ...
- Source: drugdu
- 68
- July 31, 2024
CHMP backs Boehringer’s Spevigo for preventing rare psoriasis flare-ups

The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new indication of Boehringer Ingelheim’s Spevigo (spesolimab) injection for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age. Spevigo originally received a European Commission approval for the infusion in December 2022, for the treatment of GPP flares in adults as a monotherapy. However, this approval would offer younger patients the chance to use Spevigo to prevent flare-ups. Spevigo attaches to the interleukin-36 receptor (IL-36), which plays a crucial role in the immune system’s signalling pathway and is implicated in the pathogenesis of GPP. GPP is a rare, severe type of psoriasis where patients suffer from widespread pustules on red skin, often accompanied by systemic symptoms like fever and fatigue. It is distinct from other forms of psoriasis, as it can become life-threatening due to complications ...
- Source: drugdu
- 85
- July 31, 2024

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