Search Results for “EC” – Page 286 – media

Profound Medical, Siemens Healthineers collab on ultrasound ablation

Profound Medical (Nasdaq:PROF) announced today that it entered into a non-exclusive collaboration with Siemens Healthineers. The two companies aim to lay the groundwork for Profound to begin marketing a complete therapeutics solution. They want to combine the Profound TULSA-PRO system with the Siemens Magnetom Free.Max magnetic resonance (MR) scanner. While this combination falls under the remit of Profound’s own sales force, the company also plan to market TULSA-PRO as a standalone offering. This enables customers to use the technology with the MR hardware of their choice. TULSA-PRO performs the company’s transurethral ultrasound ablation (TULSA) procedure. It employs real-time MR guidance for precision while killing targeted prostate tissue through sound absorption technology. The system enables surgeons to ablate whole- or partial-gland prostate tissue in patients with low- intermediate- or high-risk prostate cancer. It also treats benign prostatic hyperplasia (BPH). It can treat prostate cancer patients on active surveillance seeking treatment of ...
- Source: drugdu
- 88
- March 4, 2024
Tandem cycling boosts well-being for Parkinson’s patients and care partners

Pedaling on a stationary bicycle built for two may improve the health and well-being for both people with Parkinson’s disease and their care partners, according to a small, preliminary study released today, February 29, 2024, that will be presented at the American Academy of Neurology’s 76th Annual Meeting taking place April 13–18, 2024, in person in Denver and online. Jennifer Trilk, PhD, University of South Carolina School of Medicine in Greenville, said, “Our study found that a unique cycling program that pairs people with Parkinson’s disease with their care partners can improve the physical, emotional and mental well-being of both cyclists to improve their quality of life. It is just as important that care partners also receive care, so that is why we included them as the cycling partner. The goal of our small study was to determine if tandem cycling was beneficial. The next step will be to confirm ...
- Source: drugdu
- 93
- March 4, 2024
Comprehensive protein analysis reveals potential targets for treating dialysis-related amyloidosis

Dialysis patients often develop dialysis-related amyloidosis and exhibit bone and joint disorders that impair their activity of daily living. Blood purification devices consisting of hexadecyl-immobilized cellulose beads aimed at removing the precursor protein, β2- microglobulin (β2-m), are used in the treatment of dialysis-related amyloidosis. Dr. Yamamoto et al. investigated that comprehensive analysis of proteins adsorbed onto blood purification devices revealed the identification of 200 types of proteins, including β2-m. Among these, several molecules, such as lysozyme, were shown to be involved in amyloid fibril formation. I. Background of the study Patients with advanced chronic kidney disease (CKD) require kidney replacement therapy, such as hemodialysis, to manage their condition. Hemodialysis patients often experience various symptoms, leading to a compromised quality of life and reduced activity levels. Itching is a common symptom frequently observed in hemodialysis patients. Although its exact causes remain unclear, a survey conducted in Japan in 2000 found that ...
- Source: drugdu
- 131
- March 4, 2024
New Hantavirus Rapid Test Paves Way for Early Outbreak Control

Orthohantaviruses, known for their ability to cause hemorrhagic fever with renal syndrome (HFRS) in Eurasia and hantavirus cardiopulmonary syndrome in the Americas, are significant public health concerns due to their high transmission rates and impact on health. These zoonotic pathogens have been the focus of extensive research, particularly for controlling outbreaks and devising intervention strategies. In South Korea’s Gyeonggi Province, a notable number of HFRS cases have been reported, highlighting the need for diligent epidemiological surveillance and a deeper understanding of orthohantaviruses’ genomic diversity. Now, new research has unveiled the potential of cost-efficient Flongle sequencing for rapid hantavirus genome-based diagnostics and phylogeographical surveillance. A research team from Korea University College of Medicine (Seoul, South Korea) undertook a study in the Gyeonggi Province to investigate the prevalence, viral loads, and genetic variations of Hantaan orthohantavirus (HTNV). They utilized Flongle sequencing, an innovative and budget-friendly approach, for detecting HTNV genomes, emphasizing the ...
- Source: drugdu
- 101
- March 2, 2024
Nuvalent Granted FDA Breakthrough Therapy Designation for Non–Small Cell Lung Cancer Drug

February 28, 2024 Davy James NVL-520 is a novel, brain-penetrant, ROS1-selective tyrosine kinase inhibitor under evaluation for patients with metastatic ROS1-positive non–small cell lung cancer. Nuvalent, Inc’s novel, brain-penetrant, ROS1-selective tyrosine kinase inhibitor (TKI) NVL-520 has been granted Breakthrough Therapy Designation by the FDA to treat patients with metastatic ROS1-positive non–small cell lung cancer (NSCLC) who received prior therapy with at least two ROS1 TKIs.1 NVL-520 was developed with the intention of addressing treatment challenges that limit the use of current ROS1 TKIs, including treatment resistance, brain metastases, and off-target central nervous system (CNS) adverse events (AEs) that have been linked to inhibiting the structurally-related tropomyosin receptor kinase family.1 “In line with our commitment to bringing new potential best-in-class medicines to patients with cancer as quickly as possible, we are always looking for opportunities to further accelerate our programs,” James Porter, PhD, CEO of Nuvalent, said in a press release. ...
- Source: drugdu
- 87
- March 2, 2024
‘Top-down’ treatment strategy dramatically improves outcomes for Crohn’s patients

Researchers from the University of Cambridge have revealed a ‘top-down’ treatment strategy involving Janssen’s Remicade (infliximab) straight after diagnosis significantly improved outcomes for patients with Crohn’s disease. Affecting around one in 350 people in the UK, Crohn’s disease is a life-long condition caused by inflammation of the digestive tract, which can lead to flares of inflammation and progressive bowel disease damage as the condition worsens. Sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge, with support from the National Institute for Health and Care Research (NIHR), the PROFILE trial recruited 386 Crohn’s disease patients from 40 hospitals across the UK. Despite the biomarker not proving useful in selecting treatments for individual patients, patients were randomly assigned to one of two treatment groups, which were given a different treatment strategy: ‘accelerated step-up’ or ‘top-down’. The accelerated step-up group treatment approach involved patients starting Remicade if their disease ...
- Source: drugdu
- 126
- March 2, 2024
【EXPERT Q&A】How to apply for Biologics License Application (BLA)?

Drugdu.com expert’s response: The Biologics License Application (BLA) is a licensing application for biologic products, typically managed and approved by the United States Food and Drug Administration (FDA). BLA submission is required to obtain approval for the sale of biologic products in the U.S. market. The following are the key aspects to consider and the required documents for BLA submission: 1.Clinical Trial Data: Detailed clinical trial data must be provided in the BLA submission, including study design, trial results, safety, and efficacy data. These data should adhere to FDA’s requirements for clinical trial design and reporting. 2.Product Quality Control: Information on product quality control, including manufacturing processes, quality control methods, stability data, etc., needs to be provided. These data ensure that the manufacturing process and quality of the product comply with FDA requirements. 3.Nonclinical Data: Relevant nonclinical data, such as animal model studies, toxicology data, etc., should be provided to assess ...
- Source: drugdu
- 144
- February 29, 2024
Simple Measurement Predicts Risk of Rapid Progression of Chronic Kidney Disease

Chronic kidney disease (CKD) is increasingly becoming a major health issue worldwide. For those diagnosed with CKD, the rate of disease progression can vary, with some individuals experiencing a rapid deterioration in kidney function. Healthcare providers need to spot patients who are newly diagnosed with CKD and are at a heightened risk of rapid disease progression. Early identification can allow for timely interventions that could slow down, or in some cases, prevent the progression of the disease. Now, researchers have made a breakthrough by discovering a simple method to identify individuals at high risk for rapid CKD progression, an advancement that could greatly enhance prevention and treatment strategies. In a comprehensive study, a team of researchers from Aarhus University (Aarhus, Denmark) examined the precise risk of rapid CKD progression utilizing data from Danish health registers. This study provides valuable insights for medical professionals on identifying patients who are more likely ...
- Source: drugdu
- 95
- February 29, 2024
FDA Approves Imbruvica Label Expansion to Include Oral Suspension Formulation

Don Tracy, Associate Editor New label marks the first Bruton’s tyrosine kinase inhibitor to be approved with an oral suspension formulation. The FDA has approved an addendum to the Imbruvica (ibrutinib) label to include an oral suspension formulation across the drug’s indications. Johnson & Johnson (J&J), in partnership with Pharmacyclics LLC, an AbbVie Company, announced that the new formulation is approved to treat patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) following the failure of one or more lines of systemic therapy. This option is designed for patients who have difficulty swallowing pills, part of J&J’s ongoing efforts to provide multiple patient-friendly treatment options, the company stated in a press release.1 “As the most comprehensively studied therapy in its class, Imbruvica has helped change the standard of care for adults living with certain blood cancers and cGVHD. Nearly 300,000 ...
- Source: drugdu
- 129
- February 29, 2024
China’s marketed drug patent information registration platform has a new “legal document submission module”

On February 26, the Center of Drug Evaluation of the NMPA issued the “Notice on Setting up a Legal Document Submission Module on the Patent Information Registration Platform for Marketed Drugs in China” (hereinafter referred to as the “Notice”). The following is the original content of the Notice: Since the implementation of the “Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)”, patent disputes have been resolved simultaneously during the review of generic drug marketing applications. In order to further improve work efficiency and facilitate patent holders, interested parties and generic drug applicants to submit relevant legal documents, a legal document submission module has been set up on the Chinese marketed drug patent information registration platform. From the date of issuance of this notice, patentees, interested parties or generic drug applicants can directly submit an “application for setting a waiting period”, acceptance notice, judgment, decision or settlement ...
- Source: drugdu
- 86
- February 29, 2024

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