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【EXPERT Q&A】Is it easy to apply for the EU CE certification?

Drugdu.com expert’s response: CE certification is a certification system established by the European Union to ensure the safety of products for people, animals, and objects. For companies that want to export their products to EU member states, CE certification is essential. From a process perspective, CE certification is not complicated, mainly including filling out an application form, providing product information, sending samples for testing, and obtaining a certificate or report after passing the test. The entire process is usually completed within 5-7 working days. Therefore, from an operational level, CE certification is relatively easy to apply for. However, it should be noted that the preparation of technical documents involved in CE certification is relatively cumbersome, including but not limited to the product name, model, instruction manual, safety design documents, technical conditions, electrical schematics, etc. Enterprises need to ensure that these documents are complete, accurate, and comply with relevant EU standards.
- Source: drugdu
- 97
- June 28, 2024
New Urine Test Improves Accuracy for Early Detection of Bladder Cancer in Patients with Hematuria

Blood in the urine, known as hematuria, is often one of the earliest signs of bladder cancer. Although cystoscopy is recommended for patients presenting with both microscopic and gross hematuria, the detection rate for bladder cancer in these patients varies widely from 2% to 20%, leading to many unnecessary procedures. Additionally, due to the invasive nature of cystoscopy and low patient compliance, many cases of hematuria, especially microhematuria, are not promptly examined, missing early detection opportunities. This often results in diagnoses at more advanced stages, increasing both physical and economic burdens. To address these challenges, researchers have developed a simplified DNA-based urine test to enhance the early detection accuracy of bladder cancer in patients with hematuria and reduce reliance on more invasive cystoscopies. The potential of aberrant DNA methylation as a diagnostic biomarker for various cancers, including bladder cancer, has been recognized for some time. Researchers from Genomictree, Inc. (Daejeon, ...
- Source: drugdu
- 127
- June 27, 2024
Customizable AI Tool Helps Pathologists Identify Diseased Cells

Pathologists are tasked with examining body fluids or tissues to diagnose diseases, a process that involves distinguishing rare disease-indicating cells from thousands of normal cells under a microscope. This skill requires extensive training. Artificial intelligence (AI) can assist by learning to differentiate between healthy and diseased cells from digital pathology images. However, traditional AI tools, once trained, lack flexibility. They are designed for specific tasks, such as identifying cancer cells in one organ but not another, and might not align perfectly with a pathologist’s specific needs in different scenarios. Now, a collaborative team of computer scientists and physicians has developed a new AI tool that not only identifies diseased cells but also adapts to a pathologist’s requirements. Developed at Stanford Medicine (Stanford, CA, USA), the tool, named nuclei.io, functions like a human assistant that evolves with feedback. Starting with the basic function of recognizing different cell types by their nuclei, ...
- Source: drugdu
- 147
- June 27, 2024
FDA Accepts Otsuka and Lundbeck’s Supplemental New Drug Application for Brexpiprazole to Treat Adults with Post-Traumatic Stress Disorder

Don Tracy, Associate Editor Results from three randomized clinical trials show safety and efficacy of a brexpiprazole-sertraline combination in adult patients with post-traumatic stress disorder. The FDA has accepted Otsuka and Lunbdeck’s supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The sNDA is supported by data from three randomized clinical trials that evaluated the safety and efficacy of the brexpiprazole-sertraline combination in adult patients with PTSD.1 “[PTSD] is one of the most common mental health disorders in the United States. Approximately 13 million adults in the US have PTSD during a given year, and between seven to eight out of every 100 will experience PTSD at some point in their lives,” said John Kraus, MD, PhD, EVP, chief medical officer, Otsuka, in a press release. “This is a significant development, and we look forward to continuing our efforts ...
- Source: drugdu
- 121
- June 27, 2024
Novo Nordisk Drug Fails Pivotal Test in Hypertension and Chronic Kidney Disease

The Phase 3 results for ocedurenone come less than nine months after Novo Nordisk acquired the drug from KBP Biosciences. Novo Nordisk has stopped the clinical trial in uncontrolled hypertension and chronic kidney disease, but is evaluating potential applications of the small molecule in other indications. By Frank Vinluan A Novo Nordisk drug for hypertension and chronic kidney disease has failed a pivotal study, a setback to the Danish pharmaceutical giant’s effort to bring patients a new therapy with potential safety and efficacy advantages over currently approved medications in the drug class, including a product marketed by Bayer. Novo Nordisk did not release specific details about the Phase 3 results for the drug, ocedurenone. The company said Wednesday that an independent data monitoring committee recommended stopping the trial after a prespecified interim analysis. Ocedurenone is a small molecule designed to block the mineralocorticoid receptor. When overactivated, this receptor can contribute to ...
- Source: drugdu
- 106
- June 27, 2024
Chiatai Tianqing’s Liraglutide Approved for Listing, Formally Entering the Field of Biological Drugs to Control Glucose

On June 25, Chiatai Tianqing received the Certificate of Drug Registration approved by the State Drug Administration, and the company’s liraglutide injection was approved to be listed in the market, which is used for controlling blood glucose in adult patients with type 2 diabetes mellitus. This is the ninth new product (including new indications) approved by Chiatai Tianqing since this year. The approval of this product also marks Chiatai Tianqing’s formal entry into the field of biopharmaceutical glycemic control. Liraglutide is a long-acting analog of glucagon-like peptide-1 (GLP-1) with 97% homology to natural GLP-1, an endogenous enteric insulinotropic hormone that enhances glucose-dependent insulin secretion from pancreatic β-cells. In addition to pancreatic islet cells, GLP-1 receptors are widely present in gastrointestinal, lung, brain, kidney, cardiovascular system and other organs and tissues. Liraglutide prolongs the half-life of GLP-1 on the basis of retaining the physiological action characteristics of GLP-1, and needs to ...
- Source: drugdu
- 89
- June 27, 2024
Fosun Pharma to Privatize Henlius for $5.407 Billion, Integrate Innovative Assets to Further Focus on Pharmaceutical Business

On June 24, 2024, Fosun Pharma (600196.SH; 02196.HK) announced that it intends to privatize its subsidiary, Henlius (02696.HK), through a merger by absorption. The cash consideration for this absorption and merger transaction is HK$24.6 per share, which is a premium of 36.67% to the closing price of Henlius H shares on the undisturbed date; and a premium of 52.04% to the 30 trading days prior to the undisturbed date. The aggregate cash consideration for the Merger by Absorption shall not exceed approximately HK$5,407 million or its equivalent in RMB. As a core innovative asset of Fosun Pharma, Fuhong Henlius, upon completion of the transaction, will contribute to the sustainable growth of Fuhong Henlius as well as strengthen Fosun Pharma’s strategic layout in the field of innovative biopharmaceuticals. Henlius, as an international innovative biopharmaceutical company, is committed to providing affordable and high-quality biopharmaceuticals to patients around the world, with products covering ...
- Source: drugdu
- 128
- June 27, 2024
UK dementia organisations publish new manifesto ahead of general election

Alzheimer’s Society, Dementia UK, Alzheimer’s Research UK, the UK Dementia Research Institute (UK DRI) and Alzheimer Scotland have collaborated to create a new manifesto for dementia, ahead of the 2024 general election (4 July). The new manifesto, ‘Dementia: a manifesto’, calls on the next UK government to make dementia a key health priority in the UK. Affecting 982,000 people in the UK, dementia is a term for the impaired ability to remember, think or make decisions in day-to-day life. There is currently no cure available and the care and treatment options that currently exist for patients living with the neurodegenerative disease are often disjointed, inaccessible and inadequate. The new manifestos call on the next UK government to better understand how to prevent, reduce and delay dementia; increase access to diagnosis and treatment; help people living with dementia navigate support groups; create a care system that works for everyone; and invest ...
- Source: drugdu
- 107
- June 27, 2024
Europe contributes over €750m to African Vaccines Manufacturing Accelerator

The EU, its Member States and European financial institutions have announced a more than €750m contribution to the newly launched African Vaccines Manufacturing Accelerator (AVMA) as part of the EU’s Global Gateway strategy. Over the next decade, the AVMA aims to purchase more than 800 million vaccine doses produced in Africa, making more than €1bn available to manufacturers to offset high start-up costs while providing assurance of demand. Developed by Gavi, the Vaccine Alliance and the Africa Centres for Disease Control and Prevention, the AVMA has the potential to improve African pandemics, outbreaks, preparedness and responses, as well as to support global health security. It aims to enhance the predictability of demand for vaccines made in Africa, support the growth of its manufacturing base and achieve its ambition to produce most vaccines required by African countries on the continent while also helping to diversify a set of global vaccine suppliers ...
- Source: drugdu
- 87
- June 27, 2024
Low-Cost CRISPR-Based Paper Strip Test to Improve Flu Diagnosis and Surveillance

Annually, less than 1% of people who contract the flu are tested, largely due to the need for skilled personnel and sophisticated equipment. Now, researchers have developed a low-cost paper strip test that could enable more individuals to determine the type of flu they have and receive appropriate treatment. This innovative test developed by researchers from the Broad Institute of MIT and Harvard (Cambridge, MA, USA) and Princeton University (Princeton, NJ, USA) employs CRISPR technology to differentiate between the primary seasonal flu types, influenza A and B, and the subtypes H1N1 and H3N2. It can also identify strains resistant to antiviral treatments and could potentially extend to detecting swine and avian flu strains, including H5N1, which currently affects cattle. This could enhance both outbreak response and clinical care by making accurate, affordable, and rapid testing accessible in doctors’ offices and laboratories across the world. The test is based on a ...
- Source: drugdu
- 125
- June 26, 2024

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