Search Results for “EC” – Page 36 – media

Positive Results from Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) in Patients with Giant Cell Arteritis

On April 18, AbbVie announced positive results from SELECT-GCA. Based on the results of this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, upadacitinib (RINVOQ®; 15 mg once daily) in combination with a 26-week hormone tapering regimen met the primary endpoint of sustained remissiona in adult patients with giant cell arteritis (GCA) from Week 12 to Week 52. In this study, 46% of patients treated with Rinvoq in combination with the 26-week hormone tapering regimen achieved sustained remission, compared to 29% of patients treated with placebo in combination with the 52-week hormone tapering regimen (p=0.0019). Dr. Kori Wallace, Vice President, Global Head of Clinical Development, Immunology at AbbVie, said, “Many patients with GCA continue to suffer from the potentially debilitating symptoms of the disease, and their treatment options are limited. These results demonstrate that there remains a significant medical need for this type of disease, and we are relentlessly committed to ...
- Source: drugdu
- 75
- April 25, 2024
First Subject Dosed for Phase 1 Clinical Trial of Henlius’ Novel Anti-GARP/TGF-β1 mAb HLX6018

Shanghai, China, April 23, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced the first subject was dosed for a phase 1 clinical trial of HLX6018 (NCT06310746), a novel anti-GARP/TGF-β1 monoclonal antibody (mAb) independently developed by the company. HLX6018 is the first innovative product of Henlius in the treatment field of chronic inflammatory diseases, and it was recently approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF). Currently, no product targeting GARP/TGF-β1 has been approved for marketing globally. Fibrosis is a pathological process characterised by persistent tissue scars which attributed to excessive deposition of extracellular matrix (ECM). This condition can be induced by a variety of stimuli such as infections, autoimmune reactions, radiation, and tissue injury. Common fibrosis-related diseases include IPF, non-alcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), cirrhosis, chronic kidney disease (CKD), myocardial infarction (MI), etc. Among them, IPF is a chronic, progressive interstitial ...
- Source: drugdu
- 116
- April 25, 2024
Trial reveals mechanisms that contribute to impact of malnutrition and HIV infection

Severe acute malnutrition is responsible for nearly half of all child deaths globally and affects 17 million children annually A trial led by researchers at Queen Mary University London, in partnership with two research institutes in Zambia and Zimbabwe, has identified the mechanisms that contribute to the long-term impacts of severe acute malnutrition (SAM) and HIV infection in children. Funded through the Medical Research Council’s (MRC) Global Challenges Research Fund, the study published in Nature Communications aims to identify a treatment to promote the healing of intestinal damage caused by SAM. Affecting around 17 million children every year, predominantly in Africa, SAM and malnutrition are responsible for almost half of all child deaths globally and cause damage to the enteropathy, the small intestine, by reducing its ability to absorb nutrients. The new phase 2 trial, involving 125 children who had been hospitalised due to complications from arising SAM, evaluated four ...
- Source: drugdu
- 111
- April 25, 2024
GenFleet Therapeutics Announces FDA’s Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer

SHANGHAI, April 19, 2024 /PRNewswire/ — GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients. It is the first phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients worldwide, with GFH925 being the first G12C inhibitor that received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for previously treated advanced CRC. GFH925 was also granted BTD and New Drug Application acceptance with Priority Review Designation by NMPA for previously treated advanced non-small cell lung cancer（NSCLC）patients with G12C mutation. The trial (GFH925X0301) will enroll refractory metastatic CRC patients harboring KRAS G12C mutation who have progressed or experienced disease recurrence on or after at least two prior ...
- Source: drugdu
- 114
- April 24, 2024
New clinical trial aims to investigate skin patches to spot lung transplant rejection

Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50% A new clinical trial being led by the University of Oxford’s Surgical Trial Units in collaboration with NHS Blood and Transplant and five UK lung transplant centres will investigate whether skin patches can be used as an early warning system to detect lung transplant rejection. The SENTINEL trial is being funded by £2m in partnership with the Medical Research Council and the National Institute for Health and Care Research. Lung transplant rejection is commonly monitored through lung function tests, blood tests, X-rays and lung biopsies. However, until it is advanced, lung transplant rejection can be challenging to identify. The new trial aims to investigate the new early warning system to identify early signs of rejection to be rolled out to all lung transplant recipients, cutting rejection by up to 50%. Set to be carried ...
- Source: drugdu
- 73
- April 24, 2024
AI Tool Precisely Matches Cancer Drugs to Patients Using Information from Each Tumor Cell

Current strategies for matching cancer patients with specific treatments often depend on bulk sequencing of tumor DNA and RNA, which provides an average profile from all cells within a tumor sample. However, tumors are heterogeneous, containing multiple subpopulations of cells, or clones, each potentially responding differently to treatments. This variability may explain why some patients either fail to respond to certain treatments or develop resistance. Single-cell RNA sequencing offers higher-resolution data than bulk sequencing, capturing data at the single-cell level. This approach to identify and target individual clones may lead to more lasting drug responses, although, single-cell gene expression data are more expensive to generate and less accessible in clinical environments. In a proof-of-concept study, researchers at the National Institutes of Health (NIH, Bethesda, MD, US) have developed an artificial intelligence (AI) tool that leverages data from individual tumor cells to predict how well a person’s cancer might respond to ...
- Source: drugdu
- 119
- April 23, 2024
IceCure submits final breast cancer cryoablation data to FDA

BY SEAN WHOOLEYIceCure Medical (Nasdaq:ICCM) announced today that it submitted final data to the FDA requesting marketing authorization for its ProSense system. Caesarea, Israel-based IceCure designed ProSense to deliver cryoablation that treats breast cancer in a 20-40-minute outpatient procedure. It seeks FDA authorization for treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense already holds FDA breakthrough device designation and has clearance in the U.S. for other indications. Those include treating benign tumors of the breast, and tumors in the kidney and liver. However, the FDA in 2022 denied IceCure’s de novo classification request for ProSense to treat patients with early-stage, low-risk breast cancer. In January of this year, the FDA agreed to reopen the de novo file. An affirmative response from the FDA provided IceCure with a potential pathway to clearance. The company submitted a five-year follow-up dataset from the ICE3 study and ...
- Source: drugdu
- 106
- April 22, 2024
Boston Scientific recalls blood-blocking agent linked to 2 deaths

Dive Brief Boston Scientific has recalled an agent used to block blood flow to specific vessels due to a safety problem that has been tied to seven injuries and two deaths, the Food and Drug Administration said Wednesday in a recall notice. The company wrote to customers in February to advise against delivering the agent via a commonly used method in some patients because of a risk of reduced blood flow to the bowel. Boston Scientific’s product, Obsidio Conformable Embolic, remains on the market, but the company advised healthcare providers to ensure information on the risk is easily accessible to all users. Dive Insight The solution flows like a liquid when force is applied, and then returns to a soft solid state when the force is removed. As a soft solid, the agent blocks blood vessels. Physicians use the product to block blood supply to tumors with large numbers of ...
- Source: drugdu
- 123
- April 22, 2024
Urine-Based Test Detects Head and Neck Cancer

Human papillomavirus (HPV) is well-known for its role in causing cervical cancer and is also increasingly identified as being responsible for cancers in the mouth, throat, and other areas of the head and neck. Early detection of cancer is essential, as it greatly improves patient outcomes. Now, a new urine-based test that can detect DNA fragments shed by head and neck tumors could potentially enable earlier detection of these cancers, which currently lack effective screening techniques. The research team at the University of Michigan (Ann Arbor, MI, USA) utilized whole genome sequencing to show that cell-free DNA fragments found in urine, which originate from tumor cells and pass from the bloodstream through the kidneys, are predominantly ultra-short, with less than 50 base pairs. Their small size makes detection difficult using traditional urine or blood-based liquid biopsy tests for circulating tumor DNA (ctDNA). Currently in the experimental stage, this mail-in test ...
- Source: drugdu
- 133
- April 20, 2024
Unique Hand-Warming Technology Supports High-Quality Fingertip Blood Sample Collection

Warming the hand is an effective way to facilitate blood collection from a fingertip, yet off-the-shelf solutions often do not fulfill laboratory requirements. Now, a unique hand-warming technology has been specifically designed to enhance the collection of high-quality blood samples from the fingertip. The hand warmer designed to improve the collection of high-quality capillary blood samples has been developed by Babson Diagnostics (Austin, TX, USA) in collaboration with experts in biomedical engineering who study the impact of heat on the human body in the design of therapeutic devices. The Babson Hand Warmer is part of its BetterWay blood testing ecosystem, which combines Babson’s proprietary sample preparation and laboratory technologies with the BD MiniDraw Capillary Collection System. This system is the result of a strategic partnership between Babson and BD (Becton, Dickinson and Company, Franklin Lakes, NJ, USA). Slated for commercial release this year, BetterWay revolutionizes blood testing by requiring just ...
- Source: drugdu
- 121
- April 20, 2024

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