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【EXPERT Q&A】FDA Approves new colorectal cancer Screening method, How will it be implemented?

Drugdu.com expert’s response: The Food and Drug Administration (FDA) in the United States has approved a novel screening method for colorectal cancer (CRC) known as Shield Blood Test, with the following specific implementation details: Ⅰ. Target Population The Shield Blood Test is approved for use in screening the average-risk population aged 45 or older for colorectal cancer. This is based on the high incidence of CRC within this age range and the importance of screening for early detection and treatment. Ⅱ. Detection Principle The Shield Blood Test is a qualitative in vitro diagnostic test designed to detect CRC-derived mutations in cell-free DNA (cfDNA) collected from blood samples using the Guardant Blood Collection Kit. This test assesses an individual’s risk of developing cancer by identifying specific biomarkers associated with CRC in the blood. III. Testing Process Sample Collection: Blood samples are collected from patients by physicians or other healthcare professionals using ...
- Source: drugdu
- 64
- August 9, 2024
Highly Accurate Blood Test Detects Pancreatic Cancer Early in At-Risk Patients

Pancreatic ductal adenocarcinoma (PDAC), the most prevalent type of pancreatic cancer, is highly lethal but can potentially be cured with surgery and modern treatments. There is a pressing need for a simple, quick, and accessible blood test to diagnose pancreatic cancer early in at-risk individuals. Now, a new pancreatic cancer detection test offers significantly improved accuracy, fulfilling this need and potentially boosting survival rates for these patients. Immunovia AB (Lund, Sweden) has reported enhanced outcomes for its next-generation test aimed at detecting early-stage PDAC in high-risk individuals. In April 2024, the company shared positive outcomes from the preliminary model-development study of its innovative pancreatic cancer detection test. This study incorporated 624 patient samples collected from 13 distinct clinical sites, including 129 samples from patients diagnosed with stage 1 or 2 PDAC and 495 control samples, primarily from individuals at elevated risk for hereditary and/or familial pancreatic cancer. The control group ...
- Source: drugdu
- 63
- August 8, 2024
Novel Cervical Cancer Screening Method to Reduce Need for Invasive Procedures

Cervical cancer remains a significant global health issue, with about 500,000 new cases identified annually. The incidence of cervical intraepithelial neoplasia (CIN), or precursor lesions to cervical cancer, is even more common, occurring 20 times as frequently. Timely detection of these conditions is crucial for effective treatment and improved patient outcomes, underscoring the importance of advancing screening techniques for CIN and cervical cancer. The primary methods currently employed are the human papillomavirus (HPV) test and cytology examination. While cytology is a longstanding method with widespread use, its sensitivity for detecting CIN is relatively low. Conversely, while HPV tests are highly sensitive, they often lack specificity since not all HPV infections lead to cervical lesions. This underscores the pressing need for more refined diagnostic approaches. Against this backdrop, researchers at Fujita Health University (Aichi, Japan) have been exploring biomarkers that could facilitate the early detection of cervical cancer. Their latest findings, ...
- Source: drugdu
- 89
- August 8, 2024
Kerendia Demonstrates Significant Efficacy Treating Heart Failure with Left Ventricular Ejection Fraction of 40% or More

By Don Tracy, Associate Editor The FINEARTS-HF study, which compared Kerendia to a placebo when added to standard therapy, met its primary endpoint by reducing cardiovascular death and total heart failure events. Results from the Phase III FINEARTS-HF study found that Bayer’s Kerendia (finerenone) demonstrated significant efficacy in treating heart failure patients with a left ventricular ejection fraction (LVEF) of 40% or greater. According to the company, the study met its primary endpoint by significantly reducing the composite measure of cardiovascular death and total heart failure events, including both hospitalizations and urgent visits for heart failure.1 “We are very excited by the positive results from the FINEARTS-HF study,” said Christian Rommel, PhD, head of Research and Development, Bayer’s Pharmaceuticals Division. “With limited options currently available for patients with this common form of heart failure with a mildly reduced or preserved ejection fraction, this news is hugely important for patients and ...
- Source: drugdu
- 57
- August 8, 2024
Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer

The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8 billion acquisition of Agios Pharmaceuticals’ oncology business. By Frank Vinluan A Servier Pharmaceuticals drug designed to penetrate the brain to hit its targets is now FDA approved for treating two rare types of brain cancer. The FDA approval announced Tuesday covers the treatment of adults and adolescents 12 and older who have Grade 2 astrocytoma or oligodendroglioma. The drug, vorasidenib, may be prescribed after surgery, as long as the cancers have mutations to the IDH1 or IDH2 enzymes the once-daily pill is designed to inhibit. The FDA said this regulatory decision marks the agency’s first for a systemic therapy for these cancers driven by either the IDH1 or IDH2 mutations. France-based Servier, which has its U.S. headquarters in Boston, will commercialize ...
- Source: drugdu
- 72
- August 8, 2024
Luye Pharma’s Dual TAAR1/5-HT2CR Agonist LY03020 Approved for Clinical Trials in China

Luye Pharma Group today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for LY03020 filed under the Class 1 pathway for investigational drugs. LY03020, a dual TAAR1/5-HT2CR agonist, is intended to treat schizophrenia and Alzheimer’s disease psychosis (ADP). Developed on Luye Pharma’s New Chemical Entity/New Therapeutic Entity (NCE/NTE) platform, LY03020 is a next-generation antipsychotic and the first agonist against both the trace amine-associated receptor 1 (TAAR1) and the 5-HT2C receptor (5-HT2CR) in the world. “Unlike the existing antipsychotics that typically antagonize D2 and 5-HT2A receptors on the postsynaptic membrane, the next-generation antipsychotics agonize those receptors on the presynaptic membrane. Compared with the existing antipsychotics, LY03020 targets both TAAR1 and 5-HT2CR, and thus is able to reduce adverse reactions such as extrapyramidal symptoms (EPS) and metabolic syndromes while significantly improving the negative symptoms and cognitive impairments ...
- Source: drugdu
- 76
- August 8, 2024
Buyout of China’s drug companies by global pharma giants sparks national security fears

Chinese pharmaceutical industry insiders have warned that foreign takeovers may damage the sector and even threaten national security. Since December, five Chinese biotech drug makers have been sold to global pharmaceutical giants. Industry insiders have warned that this could have a negative impact, especially given the risk that the United States could extend its technology sanctions to essential medicines. John Cai, chairman of China Healthcare Innovation Platform Academy, a healthcare think tank in Shanghai, said: “When national conflicts occur and drugs are sanctioned as strategic products, it will affect the health of a country’s population. “Considering that China’s biopharmaceutical and broader healthcare industry are now facing international competition and restrictions, Beijing should act with a sense of urgency.” He also said that research and development was a long process and if innovative products were sold as soon as they were developed, it would be difficult for China to cultivate world-class ...
- Source: drugdu
- 62
- August 8, 2024
BHF’s HIF funds five heart research projects over £800,000

The British Heart Foundation (BHF) has awarded five research projects more than £800,000 as part of its Healthcare Innovation Awards to improve the delivery of vital healthcare for patients. Comprising artificial intelligence (AI) and stethoscopes to offer digital access to mental health services to those living in remote areas, the projects will receive between £100,000 and £300,000 via the Healthcare Innovation Fund (HIF). Cardiovascular diseases (CVD) affect around seven million people in the UK, including coronary heart disease, the most common form of heart and circulatory disease, which affects around 2.3 million people in the UK. The HIF supports research that aims to explore and improve existing services and care for people living with heart conditions across the UK. Researchers from Imperial College London, Hull York Medical School, Leicester University Hospital, Jubilee University National Hospital and the University Hospital of Wales have been selected to receive the funding. The research ...
- Source: drugdu
- 59
- August 8, 2024
Researchers reveal brain parasites could be used to treat cognitive disorders

Researchers from the University of Glasgow, in collaboration with Tel Aviv University, along with international researchers, have revealed that brain parasites could be used to deliver drugs to the brain to treat cognitive disorders. In the study published in Nature Microbiology, researchers explored whether the common brain parasite Toxoplasma gondii could be used to deliver treatment across the blood-brain barrier, a major complication for the treatment of many neurological conditions. According to a study published in the Lancet Neurology in March and funded by the Bill & Melinda Gates Foundation, neurological conditions are considered the leading cause of ill health worldwide, with stroke, neonatal encephalopathy, migraine, Alzheimer’s disease (AD) and other dementias, and diabetic neuropathy being the biggest global contributors. Researchers engineered Toxoplasma gondii parasites to deliver the MeCP2 protein, a therapeutic protein that has been dubbed a promising target for Rett syndrome, a debilitating neurological disorder caused by mutations in ...
- Source: drugdu
- 61
- August 8, 2024
New AI Protocol Instantaneously Detects Cancer Genomic Biomarkers Directly from Tumor Biopsy Slides

The late 90s marked the beginning of the era of precision oncology, yet recent studies in the U.S. indicate that most cancer patients are not receiving FDA-approved precision therapies. Factors such as high costs, extensive tissue requirements, and lengthy processing times have hampered the broader adoption of precision oncology, often leading to treatments that are not only suboptimal but potentially harmful. A significant barrier is the lack of testing; many cancer patients endure critical delays waiting for standard genomic tests following an initial tumor diagnosis, which can be life-threatening. Now, a groundbreaking advancement has been made with the development of a new generation of artificial intelligence (AI) tools that enable the rapid and cost-effective detection of clinically actionable genomic alterations directly from tumor biopsy slides. This innovation could cut weeks and save thousands of dollars in clinical oncology treatment workflows for diseases like breast and ovarian cancers. The new AI ...
- Source: drugdu
- 86
- August 7, 2024

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