Search Results for “EC” – Page 58 – media

Novel Urinary Biomarkers with Improved Diagnostic Performance to Enable Early Detection of Lupus Nephritis

Systemic Lupus Erythematosus (SLE), widely known as lupus, is an autoimmune condition where the body’s immune system mistakenly attacks its own tissues and organs. This disease can lead to inflammation affecting various body parts, including joints, skin, kidneys, blood cells, brain, and heart. Among its manifestations, lupus nephritis stands out as one of the most severe and common, often resulting in significant morbidity and mortality. Early detection of kidney involvement in lupus patients and prompt intervention are critical in mitigating the associated pain, suffering, and potential fatality. Now, researchers have discovered new biomarkers with improved diagnostic performance for the early detection of lupus nephritis. In a significant advancement, a research team from the University of Houston (Houston, TX, USA) employed Proximity Extension Assay (PEA) proteomics—a method focused on the study of proteins in terms of their interactions, functions, compositions, and structures—on urine samples from lupus patients. This approach led to ...
- Source: drugdu
- 82
- January 25, 2024
Recbio Enters a License and Strategic Cooperation with SPIMACO

January 23 , 2024 – Jiangsu Recbio Technology Co., Ltd. (“Recbio” , HKEX:02179) is pleased to announce that the company has recently reached a License and strategic cooperation with the Saudi Arabian pharmaceutical company SPIMACO for the recombinant HPV-9 vaccine REC603. According to the agreement, Recbio exclusively authorizes SPIMACO to develop, register and commercialize the HPV-9 vaccine REC603 in 15 Middle East and North African countries, including Saudi Arabia. This strategic cooperation covers a total population of approximately 380 million in the Middle East and North African countries. Cervical cancer is the eighth most common cancer in Saudi Arabia and the eighth most common chronic cancer among women aged 15-44. The nine-valent HPV vaccine is widely regarded as the most effective vaccine against HPV and can prevent about 90% of cervical cancer and 90% of anal and genital warts. SPIMACO is one of the largest listed pharmaceutical companies in Saudi ...
- Source: drugdu
- 79
- January 25, 2024
//www.fiercepharma.com/pharma/johnson-johnson-settles-talc-consumer-protection-claims-42-states-700m

For more than 2 years, Johnson & Johnson has been plotting its future as a two-sector company. In the wake of the company’s consumer healthcare spinoff last summer, the company’s fourth-quarter results offer plenty of signs of life from the new-look J&J.After wrapping up 2023 with a total haul of $85.2 billion, the company is heading into 2024 with “multiple catalysts for growth,” CEO Joaquin Duato said on J&J’s fourth-quarter and full-year earnings conference call. Across J&J’s innovative medicines portfolio, the company’s oncology and immunology medicines generated the lion’s share of sales in 2023’s fourth quarter, helping the unit achieve operational growth in the U.S. of 9.5% during the period. Worldwide, J&J’s pharma business reeled in $13.72 billion during the fourth quarter, a 4% increase from the same period in 2022.On the immunology front, J&J’s antibody blockbuster Stelara grew its market share and demonstrated continued strength in inflammatory bowel disease (IBD), J&J said in ...
- Source: drugdu
- 81
- January 25, 2024
Johnson & Johnson inks $700M deal to resolve talc consumer protection claims from 42 states

After failing to resolve a mountain of talcum-powder lawsuits through two unsuccessful bankruptcy attempts, Johnson & Johnson has agreed to a $700 million settlement that would free the company from some consumer protection claims—and a small part of the talc litigation that it faces. J&J plans to pay $700 million to 42 states and the District of Columbia to settle claims that the company did not warn of the potential health risks posed by its talcum-based products, including its iconic Johnson’s Baby Powder.Bloomberg first revealed the agreement two weeks ago, with the company confirming the news to the Wall Street Journal on Tuesday. “Consistent with the plan we outlined last year, the company continues to pursue several paths to achieve a comprehensive and final resolution of the talc litigation,” J&J litigation chief Erik Haas said in an emailed statement confirming the report. “We will continue to address the claims of those who do not ...
- Source: drugdu
- 178
- January 25, 2024
【EXPERT Q&A】Which in vitro diagnostic medical devices are required to be assessed by EURLs for export to the EU, and what are the specific reference laboratories involved?

Drugdu.com expert’s response: For the export of in vitro diagnostic (IVD) medical devices to the European Union, certain types of products may require assessment or testing by designated European Union Reference Laboratories (EURLs). These reference laboratories mainly focus on high-risk in vitro diagnostic medical devices, particularly those closely related to public health. The types of IVD products typically evaluated by EURLs include: Infectious Disease Diagnostic Devices: For detecting major infectious diseases such as HIV, Hepatitis B, and Hepatitis C. Blood Screening Devices: Used for blood safety testing, such as devices for detecting pathogens in blood. High-Risk Cancer Biomarker Diagnostic Devices: For detecting high-risk biomarkers of certain types of cancer. Genetic Disease Diagnostic Devices: For detecting specific genetic diseases or susceptibilities. The EU designated reference laboratories include: ECDC (European Centre for Disease Prevention and Control): Responsible for the detection and control of infectious diseases. EURL for Blood Borne Infections: Specifically responsible ...
- Source: drugdu
- 125
- January 25, 2024
Handheld White Blood Cell Tracker to Enable Rapid Testing For Infections

White blood cells (WBC), or leukocytes, are key indicators of an individual’s immune system health. High or low WBC counts can signify the severity of an infection, indicate life-threatening conditions like sepsis, or assist in monitoring patient responses to therapies like chemotherapy and psychotropic drugs. Generally, the blood collected for WBC testing is sent to a central lab for analysis that sends results within hours, making it inconvenient and delaying time-sensitive diagnosis or treatment. Now, an innovative device can rapidly count a person’s WBC with a single drop of blood, similar to the way glucometers rapidly scan for blood sugar levels, enabling rapid testing and improved triaging for infections. Called the CytoTracker Leukometer, the device developed by researchers at Rutgers startup RizLab Health Inc. (Princeton, NJ, USA) can quickly aid the detection of elevated or reduced WBC counts. The device has undergone comprehensive testing, comparing its performance with conventional ...
- Source: https://www.labmedica.com/hematology/articles/294799967/handheld-white-blood-cell-tracker-to-enable-rapid-testing-for-infections.html
- 181
- January 24, 2024
New Liquid Biopsy Approach Improves Blood Tests’ Ability to Detect Circulating Tumor DNA

Tumors continuously release DNA from dying cells into the bloodstream, which is rapidly broken down. This makes it difficult for existing blood tests to detect the minute amounts of tumor DNA present at any given time. Now, a team of researchers has developed an innovative method to amplify the detection of tumor DNA in blood, a breakthrough that could enhance cancer diagnosis and treatment monitoring. Researchers at Massachusetts Institute of Technology (MIT, Cambridge, MA, USA) have created “priming agents,” injectable molecules that temporarily slow the clearance of circulating tumor DNA from the bloodstream. These priming agents target the body’s two main mechanisms for removing circulating DNA: DNases, enzymes that break down DNA in the blood, and macrophages, immune cells that absorb cell-free DNA during blood filtration through the liver. The researchers developed two types of priming agents. The first is a monoclonal antibody that attaches to circulating DNA, shielding ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294799968/new-liquid-biopsy-approach-improves-blood-tests-ability-to-detect-circulating-tumor-dna.html
- 132
- January 24, 2024
SinoCellTech SCTC21C Injection Receives Drug Clinical Trial Approval

SinoCellTech (hereinafter referred to as the “Company”) has received the Notice of Approval for Drug Clinical Trial issued by the State Drug Administration (hereinafter referred to as the “SDA”), agreeing that the Company’s self-developed product, SCTC21C Injection, could be used in clinical trials for the treatment of CD38+ hematologic malignancies. (hereinafter referred to as the “Company”) received a Notice of Approval for Clinical Trial of Drugs from the State Drug Administration (hereinafter referred to as the “SDA”), agreeing to carry out a clinical trial of the Company’s self-developed product, SCTC21C Injection, for the treatment of CD38+ hematologic malignancies. As there are many unpredictable factors in the process of clinical trial of drugs, the results of clinical trial, review and approval as well as the timing are subject to a certain degree of uncertainty, we respectfully request investors to make decisions cautiously and pay attention to the prevention of investment ...
- Source: https://mp.weixin.qq.com/s/kGdV5hX3S2pN8s5z6zQhSA
- 189
- January 24, 2024
Bristol Myers shows power of Opdivo-Yervoy combo in first-line colorectal cancer subset

More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnosed patients. But another approval may have to wait. The dual immunotherapy combo of Opdivo and Yervoy cut the risk of disease progression or death by 79% compared with chemotherapy—with or without targeted therapies—in patients newly diagnosed with metastatic colorectal cancer that was microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR). Investigators shared the results, from the CheckMate 8HW study, at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium. After about two years of median follow-up, 72% of patients who received the anti-PD-1/CTLA-4 combo were alive without disease progression, versus 14% in the control group. The results “have potentially practice-changing implications” for previously untreated MSI-H/dMMR metastatic colorectal cancer, lead study author Thierry Andre, M.D., from the Sorbonne Université in Paris, said in a ...
- Source: https://www.fiercepharma.com/pharma/bristol-myers-shows-opdivo-yervoy-dual-immunotherapys-power-first-line-colorectal-cancer
- 102
- January 24, 2024
Lilly’s Jaypirca tipped to capture 60% of BTK leukemia market, leaving AstraZeneca, BeiGene in the dust

Eli Lilly’s attempt to wrestle a leukemia market from companies including AbbVie, AstraZeneca, BeiGene and Johnson & Johnson has analysts purring, with the GlobalData team tipping the drugmaker to capture 60% of demand and deliver $3 billion in annual sales. The GlobalData report covers the use of BTK inhibitors in the treatment of chronic lymphocytic leukemia (CLL). Pharmacyclics, now part of AbbVie, and J&J created the market with Imbruvica but now face a sea of threats, with the Inflation Reduction Act, increased competition and the looming prospect of generics pointing to a downward trajectory. AstraZeneca’s Calquence began challenging Imbruvica for the CLL market in 2019 and BeiGene’s Brukinsa joined the party last year. But the GlobalData analysts expect Lilly to come from behind to become the dominant force in CLL in the coming years. Lilly won accelerated FDA approval for Jaypirca in CLL last month. While the drugmaker, which acquired Jaypirca in its $8 billion ...
- Source: https://www.pharma.com/marketing/lillys-jaypirca-tipped-capture-60-btk-leukemia-market-leaving-astrazeneca-beigene-dust
- 156
- January 24, 2024

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