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MHRA approves Astellas’ Vyloy combination for gastric cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Astellas Pharma’s Vyloy (zolbetuximab) as part of a first-line combination treatment for a subset of gastric cancer patients. The monoclonal antibody has been authorised for use alongside chemotherapy to treat adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are claudin 18.2 positive. In the UK, adenocarcinomas, which develop from cells in the innermost lining of the stomach, account for most cases of gastric cancer, with around 6,600 people diagnosed every year. Most cases go undetected until an advanced stage, as the disease rarely causes early symptoms and tends to develop slowly over a number of years. Vyloy is now the only licensed treatment to target the claudin 18.2 protein, which is expressed in gastric, oesophageal, lung and ovarian tissues, and is administered intravenously every two to three ...
- Source: drugdu
- 59
- August 29, 2024
Improving tracking of AMR bacteria in hospitals using new genomic technique

Using a genomic approach, researchers have developed a way to simultaneously track the spread of multiple common antibiotic-resistant bacteria in hospitals. Current methods culture and sequence all pathogens separately so the new sequencing technique could help to prevent and manage hospital infections more quickly and effectively. Published in the Lancet Microbe, the proof-of-concept study from the Wellcome Sanger Institute, the University of Oslo, Fondazione IRCCS Policlinico San Matteo in Italy and collaborators captured the whole population of pathogenic bacteria found in the gut, upper airways and lungs of patients in multiple hospital intensive care units (ICUs) and ordinary wards during the first wave of the COVID-19 pandemic in 2020. The team found that, with most ICU patients colonised by several treatment-resistant bacteria and all patients colonised by at least one, they were able to determine which type of bacteria each patient had. Antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi ...
- Source: drugdu
- 67
- August 29, 2024
AI-Based Digital Pathology Platform Improves Lung Cancer Diagnosis

Lung cancer ranks among the most prevalent and fatal cancers worldwide. Current treatment strategies for lung cancer patients rely on pathological examinations, which can reveal genetic mutations specific to the patient’s cancer, facilitating personalized treatment approaches. Over the last few years, pathology has evolved dramatically due to digital advancements, making traditional microscopes obsolete. Tissue samples are now digitized and analyzed via computer screens, which is essential for employing sophisticated artificial intelligence (AI)-based analytical methods. These AI technologies can extract additional insights from pathological tissue sections that were previously unattainable. A team of researchers at the University of Cologne (Cologne, Germany) has developed an AI-driven digital pathology platform that can revolutionize the analysis of lung cancer tissues. This platform utilizes newly developed algorithms to perform fully automated examination of digitized lung cancer tissue sections, offering faster and more precise analyses than traditional methods. Detailed in their publication in the journal Cell ...
- Source: drugdu
- 65
- August 28, 2024
Novel Blood-Based Risk Score Based on Lipids Improves Prediction of Heart Disease

In the field of cardiovascular health, some individuals fall into an ambiguous “intermediate zone” of risk for heart attacks or strokes—neither distinctly low nor high-risk, yet potentially on the cusp of heart disease. This grey area calls for improved methodologies for accurate risk prediction. Traditionally, risk assessments like the widely recognized Framingham Risk Score have utilized factors such as levels of ‘good’ and ‘bad’ cholesterol to categorize individuals into risk groups. However, these conventional tools have several limitations, especially in identifying the risks for those in this intermediate category. This oversight is particularly critical as heart disease can progress silently, making early detection crucial to avoid late-stage interventions that are less effective. Now, scientists have developed and validated a novel, blood-based risk score based on lipids (fats in the blood). The tool, outlined in a paper published in the Journal of the American College of Cardiology, was developed by scientists ...
- Source: drugdu
- 78
- August 28, 2024
New drug trial to investigate treatment for patients with bronchiectasis

Bronchiectasis is the third most common lung condition in the UK but despite this, it is sometimes seen as a ‘hidden’ disease due to a lack of public awareness, investment and research. Now a multi-million-pound clinical trial is set to start in September to investigate whether existing drugs could be used to treat the debilitating lung disease. The disease results in persistent breathing difficulties and repeated lung infections when bronchi – tubes in the lungs – become permanently damaged and widened. There is currently no treatment or cure and, with an ageing population, numbers are increasing. Currently the disease affects one in 200 people in the UK (approximately 200,000), with an increase of 40% over the last ten years and an expected increase of a further 20% over the next decade. Researchers from EMBARC, the European Research Network for bronchiectasis, are working on the AIRNET (Anti-Inflammatory Repurposing Network) project to ...
- Source: drugdu
- 82
- August 28, 2024
SynaptixBio awarded £2m BioMedical Catalyst grant from Innovate UK

Oxford-based SynaptixBio has been awarded a £2m BioMedical Catalyst grant from Innovate UK to support first-in-human clinical trials of its therapeutic targeting H-ABC, the most severe form of TUBB4A leukodystrophy. In November 2023, SynaptixBio received an earlier grant from Innovate UK to expand its search for rare disease therapies. The company was given a second Orphan Drug Designation from the US FDA in February this year for a therapy targeting Isolated Hypomyelination – a less severe form of TUBB4A leukodystrophy. In the UK, a rare disease is defined as a condition that affects fewer than one in 2,000 in the population and SynaptixBio is the only company licensed to commercialise a treatment for this rare, deadly and currently incurable disease. Currently, there is no cure for TUBB4A-related leukodystrophies, a group of rare neurodegenerative caused by mutations in the TUBB4A gene. The diseases result in disruption to the signals between nerve ...
- Source: drugdu
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- August 28, 2024
Celltrion’s SteQeyma receives EC approval for chronic inflammatory diseases

The European Commission (EC) has approved Celltrion‘s SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for treating various chronic inflammatory conditions. This approval, which encompasses gastroenterology, dermatology, and rheumatology indications, follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June this year. SteQeyma, previously known as CT-P43, acts as an antagonist to human IL-12 and IL-23, addressing multiple immune-mediated diseases. It is available in subcutaneous and intravenous formulations, with the subcutaneous injection offered in 45mg/0.5ml or 90mg/1ml strengths in a single-dose, prefilled syringe. The intravenous infusion is available as a 130mg/26ml (5mg/ml) solution in a single-dose vial. Stelara, the reference product for SteQeyma, is a biologic therapy targeting interleukin (IL)-12 and IL-23 cytokines, crucial in inflammatory and immune responses. The EC’s decision is grounded on comprehensive evidence, including a Phase III trial in adults with moderate to severe plaque ...
- Source: drugdu
- 118
- August 28, 2024
MSD snags European approval for pulmonary arterial hypertension therapy

The European Commission (EC) has granted approval to Merck & Co’s (MSD) Winrevair (sotatercept) to be used as a combination therapy for the treatment of adults with functional class II or III pulmonary arterial hypertension (PAH). The approval was awarded based on data from STELLAR, a Phase III study (NCT04576988) that evaluated 323 adult participants with functional class II or III PAH, as determined by the World Health Organization (WHO), as per the 26 August press announcement, The European approval for the subcutaneously administered therapy follows one from the US Food and Drug Administration (FDA) in March 2024 for the same group of PAH patients. According to GlobalData’s consensus forecasts, Winrevair is expected to generate total sales of $6.3bn in 2030. GlobalData is the parent company of Pharmaceutical Technology. Notably, a day before the approval of Winrevair, the FDA granted approval to Johnson & Johnson’s (J&J) Opsynvi (macitentan + tadalafil). ...
- Source: drugdu
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- August 28, 2024
【EXPERT Q&A】What are the advantages of MDSAP medical device system certificate?

Drugdu.com expert’s response: The MDSAP (Medical Device Single Audit Program), also known as the “Medical Device Single Audit Program,” is an audit process recognized and joined by five medical device regulatory agencies from the United States FDA, Australia TGA, Brazil ANVISA, Canada HC, and Japan MHLW. This system certification brings numerous benefits and advantages to medical device manufacturers, primarily in the following aspects: I. Streamlining the Audit Process Reducing Redundant Audits: MDSAP employs a one-time audit process that encompasses the regulatory requirements of multiple countries. Manufacturers need to undergo a single audit to meet market access requirements across participating nations, eliminating the duplication of effort and time waste associated with multiple audits. Unifying Audit Standards: MDSAP certification ensures that a manufacturer’s quality management system and products align with the audit standards and requirements of the five participating countries and regions, facilitating consistency in quality and compliance and simplifying audit procedures ...
- Source: drugdu
- 68
- August 28, 2024
KIHE 2025

Organiser: ITE Group Time: 21 – 23 May 2025 Address：42 Timiryazev str., Almaty, 050057 Almaty, Kazakhstan Exhibition hall: Atakent International Exhibition Centre Product range: Medical equipment: Medical technology equipment, laboratory equipment, medical electronic equipment, medical diagnostic equipment, ophthalmic equipment and protective products, surgical instruments, first aid and emergency equipment, hospital & Dental & medical equipment, dental service equipment and disposable medical products, hospital and home disposable medical products, hospital dentistry, medical data processing systems, dental plastic surgery, rehabilitation equipment Drugs: foreign prescription drugs, herbal preparations, mineral supplements and vitamin and other nutritional health drugs, dietary nutritional products, homeopathic preparations, dermatological preparations, maternal and infant medical care products and baby food, personal hygiene products, incontinence products, medical consumer products, cosmetics Pharmaceutical Industry: Pharmaceutical production equipment and technology, pharmaceutical packaging equipment, pharmaceutical packaging materials, pharmaceutical production, cleaning and disinfection configuration system, pharmaceutical industry raw materials and ingredients, intermediates, pharmaceutical equipment, pharmaceutical packaging, laboratory equipment ...
- Source: drugdu
- 251
- August 27, 2024

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