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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/
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- 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
- 97
- August 1, 2024
Avzivi® (BAT1706) receives marketing approval from European Commission

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is dedicated to the development of a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology, and other major diseases that threaten human life or health. The Company recently received notification from the European Commission that Avzivi (BAT1706), a biosimilar developed by BIO-THERA with reference to Avastin® (bevacizumab), Intravenous Solution, has been granted marketing authorization by the European Commission for the treatment of metastatic colorectal, metastatic breast, non-small-cell lung, renal-cell, epithelial ovarian, fallopian tube or primary peritoneal, and cervical cancer. The decision was based on a positive review opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). In September 2021, BIO-THERA signed a commercialization and license ...
- Source: drugdu
- 91
- August 1, 2024
AST System Delivers Actionable Results for Gram-Negative Bacteria Directly from Positive Blood Cultures

Annually, sepsis claims the lives of 11 million people globally, with 1.3 million of these deaths linked to antibiotic-resistant bacteria. For clinicians, the ability to quickly and accurately interpret antimicrobial susceptibility testing (AST) results is essential to save lives and tailor treatment strategies effectively. Rapid AST not only improves patient outcomes but also reduces the global antimicrobial resistance (AMR) burden by supporting the execution of effective Antimicrobial Stewardship (AMS) programs. Predicting AMR in patients with gram-negative infections is often a more complex and time-consuming process. Early diagnosis and timely treatment are crucial in enhancing outcomes for sepsis patients. Studies have shown that each hour’s delay in administering antibiotics significantly increases the likelihood of hospital mortality, even if antibiotics are given within the first six hours. Now, a novel AST system delivers actionable results for gram-negative bacteria directly from positive blood cultures in an average of 5.5-6 hours, enabling same-day treatment ...
- Source: drugdu
- 102
- July 31, 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
- 90
- 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
- 105
- 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
- 78
- 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
- 80
- 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
- 111
- July 31, 2024
SINOPHARM and University of Macao Joint Laboratory Project Signing Completed

On July 19, 2024, the Matchmaking Meeting and Signing Ceremony of Macao-Qin Science and Technology Industry, Academia and Research Capital was held in Hengqin Guangdong-Macao Deep Cooperation Zone (hereinafter referred to as the “Zone”). For the first time, the event brought together representatives from Macao’s universities, high-quality enterprises and industrial capital to build a high-level platform for matching and exchanges between industry, academia, research and capital. At the scene of the event, 4 Macao universities signed contracts with 16 well-known enterprises and organizations in the industry. Among them, the cooperation between SINOPHARM and the University of Macau Joint Laboratory Project completed the signing. Secretary for Economy and Finance of the Macao Special Administrative Region and Director of the Executive Committee of the Zone, Mr. Li Weinong attended the event and delivered a speech. Xu Jian, Vice President of the University of Macau, Chen Guokai, President of the Institute of Science ...
- Source: drugdu
- 94
- July 31, 2024

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