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FDA Breakthrough Device Designation for DCISionRT® Test for DCIS Breast Cancer Patients

Prelude Corporation (PreludeDx®), a leader in precision diagnostics for early-stage breast cancer, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation for its DCISionRT® test. DCISionRT provides individualized risk assessment and predicts the benefit of radiation therapy (RT) for women diagnosed with ductal carcinoma in situ (DCIS), also known as Stage 0 breast cancer. DCISionRT represents a significant advancement in DCIS patient care by combining tumor biology with clinicopathologic factors to deliver personalized results. The test analyzes seven protein biomarkers and four clinical factors to generate a Decision Score that helps physicians identify which patients are most likely to benefit from RT and can help reduce over- and under-treatment. The test is designed for women aged 30-85 with DCIS and: Predicts the benefit of radiation therapy after breast conserving surgery (BCS)Is Prognostic for 10-year risk… 

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China Allows Monotherapy for Advanced Pancreatic Cancer

Innovent Biologics, Inc. („Innovent“) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343, a potentially best-in-class TOPO1i anti-CLDN18.2 ADC, as monotherapy for the treatment of CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) patients who have progressed after at least one line of prior systematic treatment. The BTD for IBI343 was granted based on data from an ongoing Phase 1 study conducted in China, Australia and the U.S. (NCT05458219), which demonstrated favorable safety and tolerability, as well as promising antitumor activity of IBI343 monotherapy in advanced PDAC patients. Data from the study’s dose-expansion cohort were presented orally at the 2024 ESMO… 

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Allianz Risk Barometer: Cyber-Attacken bleiben 2025 weltweites Top-Risiko für Unternehmen

Datenpannen, Angriffe auf kritische Infrastrukturen oder Vermögenswerte sowie Ransomware-Attacken sind für 38 Prozent der Befragten weltweit die grössten Risiken. Betriebsunterbrechungen und Naturkatastrophen belegen mit 31 bzw. 29 Prozent erneut die Plätze 2 und 3, während der Klimawandel den grössten Sprung von Rang 7 auf 5 macht. In der Schweiz liegen Cyber-Attacken mit […] Allianz Risk Barometer: Cyber-Attacken bleiben 2025 weltweites Top-Risiko für Unternehmen

FDA approves Lilly’s Omvoh® for Crohn’s disease

In the pivotal Phase 3 VIVID-1 trial, patients treated with Omvoh experienced significant improvement in clinical remission and endoscopic response at one year. Among those who achieved clinical remission and endoscopic response at one year, nearly 90% of patients maintained clinical remission with two years of continuous Omvoh treatment in open-label extension. Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults. Omvoh is now approved in the U.S. for two types of inflammatory bowel disease (IBD), following its October 2023 approval as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults.1 Omvoh works to reduce inflammation within the gastrointestinal tract by targeting a specific protein, interleukin-23p19 (IL-23p19), which is a key contributor to… 

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XRP Ledger: Revolutionizing Healthcare Operations

XRP and its underlying technology are poised to revolutionize healthcare through innovative applications and solutions that address longstanding industry challenges. The XRP Ledger (XRPL), launched in 2012, provides a robust foundation for healthcare transformation with its high-speed transactions, minimal costs, and exceptional scalability[1]. Healthcare Applications The integration of XRPL in healthcare brings several groundbreaking advantages. With transaction settlements occurring in just 3-5 seconds and costs as low as $0.0002 per transaction, the platform enables seamless and cost-effective healthcare operations[26]. This efficiency is particularly crucial for healthcare providers managing large volumes of patient transactions and data transfers. XRP Healthcare, built on the XRPL, exemplifies this transformation by consolidating private healthcare facilities and implementing advanced technologies[2]. The platform leverages artificial intelligence to optimize workflows, identify inefficiencies, and enhance patient outcomes through predictive analytics[2]. Technical Advantages for Healthcare The XRPL’s technical architecture offers… 

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Changes in Microbiome Predict Risk for Sexually Transmitted Disease

Women who develop bacterial vaginosis (BV) often later acquire chlamydia, a common and potentially serious sexually transmitted bacterial infection. Now, researchers at Albert Einstein College of Medicine, Roswell Park Comprehensive Cancer Center, and the Icahn School of Medicine at Mount Sinai have found that BV actually consists of two subtypes—one of which significantly increases the risk of developing chlamydia infections. The findings were made in a population of young Black and Hispanic women, who are disproportionately affected by both BV and chlamydia, but are historically understudied. The study, one of the largest and most comprehensive of its kind, was published online today in the journal Cell. BV is caused by imbalances in the cervicovaginal microbiome—the collection of bacteria naturally found in the genital tract. Common symptoms include vaginal discharge, itching or irritation, and burning sensation during urination, although many cases… 

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Promising results from first patients implanted with spinal neurostimulator

A team of doctors and researchers from the IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University of Milan and of bioengineers from the Scuola Superiore Sant’Anna of Pisa, has obtained promising results in the treatment of spinal cord injuries, thanks to an innovative protocol based on high-frequency, epidural electric stimulation. The study, published in Science Translational Medicine, has shown that this technique significantly reduces muscle spasticity and improves motor functions in patients with spinal cord injury. The research has focused on two patients with incomplete spinal cord injuries that during 2023 had recovered their motor skills. This was possible thanks to the implantation of the spinal cord neurostimulator, a device already used in pain therapy. Researchers have applied targeted, high-frequency stimulations that, together with specific rehabilitation programs, have significantly improved muscular strength, walking ability and motor control of the… 

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Schlechte Luft und Lärm plagen Europas Städte

Die Umweltbelastung in den Städten der EU zählt nach wie vor zu den größten Risikofaktoren für die Gesundheit. Dies geht aus einem heute veröffentlichten Bericht des Europäischen Rechnungshofs hervor. Europäische Städte seien zu laut. Zudem sei die Luftverschmutzung nach wie vor zu hoch, auch wenn sich die Lage verbessert habe. Dies gebe besonderen Anlass zur Sorge, da die EU und ihre Mitgliedstaaten ihre Anstrengungen in den kommenden Jahren weiter verstärken müssten, um die künftig strengeren Grenzwerte für Luftschadstoffe einhalten zu können. Drei Viertel der Bürgerinnen und Bürger in der EU leben in Ballungsräumen und sind daher in besonderem Maße von Luftverschmutzung und Lärmbelastung betroffen. Nach Angaben der Europäischen Umweltagentur sterben in Europa jährlich mindestens 250 000 Menschen als Folge der Luftverschmutzung. Auch eine langfristige Lärmbelastung kann der Gesundheit schaden und beispielsweise zu Schlafstörungen, Angstzuständen, kognitiven Beeinträchtigungen und psychischen Erkrankungen führen.… 

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EsoBiotec’s ESO-T01 CAR-T therapy enters the clinic

Chromatin Bioscience is pleased to announce its ongoing collaboration with EsoBiotec, which has successfully advanced its ESO-T01 in vivo CAR-T candidate into clinical trials. ESO-T01 is the first in vivo B-cell maturation antigen (BCMA) CAR-T candidate to reach the clinical stage and utilises a synthetic promoter designed using Chromatin Bio’s proprietary promoter design platform, chromatinLENS, exclusively for EsoBiotec as part of its innovative approach to immunotherapy. EsoBiotec’s ESO-T01, developed using its ENaBL platform, is a T cell targeted lentiviral vector expressing a BCMA-targeted CAR construct for the treatment of multiple myeloma. This construct is regulated by a Treg-specific synthetic promoter developed in collaboration with Chromatin Bioscience. Early studies demonstrated highly effective in vivo transduction, with the BCMA CAR transgene expressed specifically in T cells, leading to the generation of a large population of circulating BCMA CAR-T cells that persisted throughout… 

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Auswirkungen von Pestiziden auf Bienen komplexer als erwartet

Eine neue Studie zeigt die unterschiedlichen Auswirkungen der Exposition gegenüber Neonicotinoid-Pestiziden auf verschiedene Körperteile von Hummeln. Dies erklärt, warum Pestizide so unterschiedliche schädliche Auswirkungen haben, und unterstreicht die Notwendigkeit sensiblerer Sicherheitstests. Forscher der Queen Mary University of London haben entdeckt, dass das Neonicotinoid-Pestizid Clothianidin verschiedene Körperteile von Hummeln auf ganz unterschiedliche Weise schädigt. Die neue Studie der Forscher zeigt, dass die Auswirkungen von Pestiziden alles andere als einheitlich sind. Sie wirken sich auf unterschiedliche Weise auf Gehirn, Beine und nierenähnliches Gewebe aus und beeinträchtigen so die wesentlichen Funktionen jedes Gewebes. Deutliche Auswirkungen auf verschiedene Gewebe: Indem sie Hummeln einer praxisnahen Dosis Clothianidin aussetzten, stellten die Wissenschaftler dramatische Unterschiede in der Genaktivität verschiedener Körpergewebe fest – 82 % der Veränderungen der Genaktivität waren gewebespezifisch. „Jedes von uns untersuchte Gewebe war stark vom Pestizid betroffen“, erklärt Professor Yannick Wurm. „Die Auswirkungen der… 

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