Recently, Zhejiang Pukang Biotechnology Co., Ltd. has completed the Phase IV clinical trial titled “Single-Arm, Multi-Center Evaluation of the Safety and Immunogenicity of Freeze-Dried Live Attenuated Hepatitis A Vaccine in Chinese Children Aged 18-24 Months” and received the final report. This Phase IV clinical study, involving a large sample size of 10,000 cases across multiple centers, aimed to observe the safety and immunogenicity of the freeze-dried live attenuated Hepatitis A vaccine in the real world. The study results show that after a single dose of the vaccine, the AEFI incidence rate in the 18-24 month-old children was 0.34%, with no serious AEFI reported, and an antibody seroconversion rate of 98.91%. This confirms the vaccine’s good safety and immunogenicity profile, providing richer data support for its widespread application. The freeze-dried live attenuated Hepatitis A vaccine (H2 strain), developed and produced by Zhejiang Pukang Biotechnology Co., Ltd., simulates ...
Some HIV patients are naturally able to keep the virus fully in check without any medicinal help, a phenomenon that has intrigued scientists for decades. New research appears to identify at least one reason why: an abnormally powerful version of an infection-fighting white blood cell called CD8+ T cell. CD8+ T cell’s are a type of T cell, a normal feature in everyone’s immune system. T cells typically amass in the lymph nodes of an HIV-infected patient. But among “spontaneous controllers”—those with the rare ability to automatically corral HIV and prevent it from triggering illness—investigators found that CD8+ T cells appear significantly more adept at identifying and stopping HIV. “About one in 300 people are able to control HIV without the need for medications,” noted study author Dr. Bruce Walker, director of the Ragon Institute of MGH, MIT and Harvard, an immune system research center in Cambridge, Mass. It appears ...
Incyte’s Opzelura cream may be looking at a new competitive rival in the lucrative atopic dermatitis field. Wednesday, Dermavant Sciences said its topical drug Vtama has come out successful in the first of two phase 3 studies the company is running in atopic dermatitis. As William Blair analysts see it, Vtama’s results put it “in reach of Opzelura on efficacy,” although one important data point remains unknown. In a phase 3 trial called ADORING 2, 46.4% of eczema patients who received the Vtama cream enjoyed clear or almost clear skin at week 8 while demonstrating at least a two-grade improvement from baseline. Vtama’s skin clearance rate was higher than the 18% observed in control patients who got a dummy therapy. Vtama also aced other secondary endpoints. The topical AHR agonist helped 59.1% of patients experience a 75% reduction from baseline in the Eczema Area and Severity Index (EASI), versus 21.2% in the ...
Brigham researchers studying how and why certain cell types proliferate in the gut found that xanthine, which is found in coffee, tea and chocolate, may play a role in Th17 differentiation. Insights may help investigators better understand gut health and the development of conditions such as inflammatory bowel disease. The gut is home to a cast of microbes that influence health and disease. Some types of microorganisms are thought to contribute to the development of inflammatory conditions, such as inflammatory bowel disease (IBD), but the exact cascade of events that leads from microbes to immune cells to disease remains mysterious. A new study by investigators from Brigham and Women’s Hospital explores exactly what leads to the generation of Th17 cells—an important subtype of cells in the intestine—and uncovers some of the underappreciated molecular players and events that lead to cell differentiation in the gut. One of those players is the purine metabolite xanthine, which is found ...
In a recent study posted to the Research Square* preprint server, an international team of researchers review current literature to understand the association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, abnormal neuroimaging manifestations, and neurological symptoms among individuals under the age of 18. Background The clinical presentation of the coronavirus disease 2019 (COVID-19) varies widely across individuals, ranging from asymptomatic or mild to severe cases involving acute respiratory distress syndrome (ARDS), pneumonia, and multi-organ complications. Emerging evidence suggests that the thrombogenic reactions and cytokine storm that develop during acute COVID-19 contribute to psychiatric and neurological complications, with a high incidence of intracerebral hemorrhage and ischemic stroke. While many studies have investigated the neurological complications associated with acute SARS-CoV-2 infections among adults, COVID-19 manifestations among children have largely been asymptomatic or mildly symptomatic and not require hospitalization. However, emerging evidence indicates that systemic symptoms such as secondary inflammatory responses, which are collectively known ...
Image: Sysmex and Siemens have established global agreement to supply hemostasis instruments and reagents as OEMs (Photo courtesy of Sysmex) Sysmex Corporation (Kobe, Japan) and Siemens Healthcare Diagnostics Inc. (Siemens Healthineers, Erlangen, Germany) have signed a global OEM agreement on hemostasis products under which each company will supply the other with their products in the diagnostic field of hemostasis on an OEM basis. Both Siemens and Sysmex provide hemostasis products used in testing for blood clotting disorders, preoperative bleeding risk management, and the monitoring of patients receiving anticoagulant therapy medications. Following their global agreement on distribution, sales, and services for hemostasis products signed in 1995, the two companies have since then developed a strong partnership and gone on to become one of the leading solution providers in the global hemostasis space. Over this period, the companies have further expanded their capabilities and gained strength by introducing new innovations in ...
The pharmaceutical foreign trade industry is fiercely competitive, demanding a constant grasp of the latest market information and tech tools to successfully expand business. Today, we're showcasing must-have websites and practical tools for pharmaceutical foreign trade professionals, empowering you to operate more efficiently.
If small biotech does more to plan ahead for ex-US market requirements, companies and their investors – and crucially patients – will benefit.
Medtech’s resilience and flexibility have been clear to see during the COVID-19 pandemic. In this forward-looking view for 2022, CEOs from some of the Top 50 global medtechs share their perspectives on the present and the future, from company and health care system standpoints.
Researchers from the RIKEN Center for Advanced Intelligence Project (AIP) and colleagues have tested AI-enhanced diagnosis of fetal congenital heart disease in a clinical setting. Both hospital residents and fellows made more accurate diagnoses when they used a graphical interface that represented the AI's analysis of fetal cardiac ultrasound screening videos. The new system could help train doctors as well as assist in diagnoses when specialists are unavailable. The report recently appeared in the scientific journal Biomedicines.
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