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New study examines educational disruptions for children

Children with special health care needs (CSHCN) often face significant disruptions in their education due to extended hospitalizations. A recent study published online in Disability and Rehabilitation on July 1, 2024, by a multidisciplinary team of Kessler Foundation and Children Specialized Hospital researchers, highlights critical areas needing attention to ensure smoother school re-entries for CSHCN, ensuring they receive the necessary educational support post-hospitalization. Involving parents, former patients, and rehabilitation professionals, the study underscores the need for better coordination and communication to facilitate seamless transitions back to school for CSHCN. Titled Experiences of patients, parents, and healthcare professionals in the process of transitioning from hospital to community after inpatient pediatric rehabilitation among children with special health care needs (https://doi.org/10.1080/09638288.2024.2362951), the article offers insights into the challenges and solutions for improving school re-entry for CSHCN. Foundation authors are Yu-Lun Chen, PhD, OTR/L; Stephanie Jimenez; Alexa Bartalotta; John O’Neill, PhD; and Amanda L. ...
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- July 30, 2024
Imfinzi with Neoadjuvant Chemotherapy Demonstrates Significant Benefit in Event-Free Survival Treating Resectable Non-Small Cell Lung Cancer

By Don Tracy, Associate Editor FDA’s Oncologic Drugs Advisory Committee acknowledged that Imfinzi met its primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer. The FDA’s Oncologic Drugs Advisory Committee (ODAC) has found that AstraZeneca’s Imfinzi (durvalumab) achieved the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC) in the Phase III AEGEAN trial. However, AstraZeneca noted that although the contribution by phase of neoadjuvant and adjuvant components of the perioperative regimen could not be clearly assigned based on the trial design, its potential should not be overlooked. Results of the trial were published in The New England Journal of Medicine. “The majority of patients with resectable lung cancer face recurrence of their disease even after surgery and neoadjuvant chemotherapy. The Committee acknowledged the potential to address this urgent unmet need with durvalumab both before and after surgery, ...
- Source: drugdu
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- July 30, 2024
FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer

Leqselvi is now FDA approved for treating severe alopecia areata. Sun Pharma added the oral drug to its pipeline via the $576 million acquisition of Concert Pharmaceuticals last year. By Frank Vinluan Hair loss caused by alopecia areata now has a new FDA-approved treatment, a third-in-class drug from Sun Pharmaceutical Industries that will compete against commercialized medicines from Eli Lilly and Pfizer. The regulatory decision announced Friday for the drug, deuruxolitinib, covers the treatment of adults with severe alopecia areata. Mumbai, India-based Sun Pharma, which has U.S. operations in Princeton, New Jersey, will market the twice-daily pill under the brand name Leqselvi. Alopecia areata is a condition in which the immune system attacks hair follicles, causing sudden hair loss. The disorder affects both males and females. While the hair loss mainly happens on the scalp, the condition can affect other parts of the body. Sun Pharma cites studies estimating that 700,000 ...
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- July 30, 2024
Study suggests targeting amyloid beta production could be promising in AD

A study led by the UK Dementia Research Institute (UK DRI) and University College London (UCL) has suggested targeting amyloid beta production in one cell type in the brain could improve early disease outcomes, with fewer side effects, in Alzheimer’s disease (AD). Published in the journal PLOS Biology, findings suggest that targeting the production of amyloid beta specifically from oligodendrocytes could be a promising therapeutic strategy for treating the neurodegenerative condition. Currently the most common cause of dementia, AD is a progressive, neurodegenerative disease that causes the brain to shrink and brain cells to die. Accumulation of misfolded amyloid beta is recognised as one of the hallmarks of AD, which is believed to be caused by neurons. Researchers aim to test whether oligodendrocytes, a neural cell that produces myelin, the insulating material that surrounds the projections that transfer impulses between neurons, called axons, could produce harmful amyloid beta and whether ...
- Source: drugdu
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- July 30, 2024
KCL study finds cell ageing could reveal early signs of neurodegenerative disease

Researchers from King’s College London (KCL), along with other collaborators, have found that ageing cells could reveal early signs of neurodegenerative diseases, including Alzheimer’s disease or amyotrophic lateral sclerosis. Published in Aging Cell, the findings could provide a wider picture of a target area for drugs and could improve treatments for these types of conditions. Affecting more than one million people in the UK, neurodegenerative conditions, such as multiple sclerosis and Parkinson’s disease, occur when cells of the central nervous system stop working or die. Using fluorescence to measure the viscosity of neuronal cytoplasm, the fluid enclosed by the cell membrane of the neuron, in mice, researchers found that the viscosity of the cytoplasm in the neuron (soma) increased as the mice aged. However, it did not increase in the cytoplasm of the axon, a tail-like structure that transmits electrical and chemical signals to other cells. Researchers suggested that the ...
- Source: drugdu
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- July 30, 2024
Ractigen Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to RAG-18 for the treatment of Duchenne Muscular Dystrophy

SUZHOU, China, July 25, 2024 /PRNewswire/ — Ractigen Therapeutics, a pioneering developer of small activating RNA (saRNA) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to RAG-18, one of the company’s lead saRNA product candidates for the treatment of Duchenne Muscular Dystrophy (DMD). RAG-18 could represent a novel and translatable therapeutic strategy for DMD and Becker Muscular Dystrophy (BMD) caused by any mutation of the DMD gene. The RPDD is granted by the FDA to drugs that treat serious or life-threatening diseases primarily affecting children under 18 years of age with a prevalence of fewer than 200,000 in the United States. If a New Drug Application (NDA) for RAG-18 is approved, Ractigen may be eligible to receive a Priority Review Voucher (PRV), which can be used to expedite the review of a subsequent marketing application for a different product or ...
- Source: drugdu
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- July 30, 2024
Sanyou Bio Congratulates Eluminex Biosciences and Foreseen Biotechnology on Major Breakthroughs in Innovative Drug Project

SHANGHAI, July 26, 2024 /PRNewswire/ — On July 15, Eluminex Biosciences announced that their tri-specific fusion antibody drug, EB-105, has administered its first dose to a diabetic macular edema patient in the United States. This clinical trial, known as LOTUS, is an open-label, multicenter, single-dose, dose-escalation clinical trial via intravitreal injection, currently being conducted in four hospitals across the United States. On July 22, 2024, Foreseen Biotechnology announced the exclusive global licensing of their ADC targeted drug, FS001, to Ipsen Pharma SAS of France. Ipsen will have exclusive rights to develop, manufacture, and commercialize FS001 worldwide. The total licensing fee, including upfront payments, milestone payments, and sales royalties, amounts to US$1.03 billion. Eluminex Biosciences’s preclinical studies have shown that EB-105 can effectively inhibit signal transduction pathways such as VEGF-A/VEGFR-2, Ang-2/Tie-2, and IL-6/IL-6R. In addition to targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), EB-105 also inhibits intracellular inflammation-related signal ...
- Source: drugdu
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- July 30, 2024
study

Dive Brief A recent study showed that a version of ChatGPT analyzes medical images at an expert level but frequently reached the right answer with incorrect reasoning. The results, which were published Tuesday in the peer-reviewed journal npj Digital Medicine, show OpenAI’s artificial intelligence GPT-4 with vision is as good at answering multiple-choice questions about medical images as physicians who lack access to external resources. However, the model made mistakes in image comprehension, while still reaching the right answer, 27% of the time. The researchers said the errors show the need for further study before the AI models are integrated into clinical workflows. Dive Insigh GPT-4 with vision, called GPT-4V, is a version of the ChatGPT large language model that can analyze images and text at the same time. Pilot medical studies found the model outperformed medical students and physicians in closed-book settings. However, those studies looked at the answers ...
- Source: drugdu
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- July 29, 2024
Abbott recalls Freestyle Libre 3 sensors due to incorrect glucose readings

Dive Brief Abbott has recalled a small number of Freestyle Libre 3 sensors distributed in the U.S. in the first half of May, the company said Wednesday. Internal testing found a subset of three lots of the continuous glucose monitor (CGM) sensors may provide incorrect high glucose readings, the company said. The false readings could lead to incorrect treatment decisions, such as taking insulin when not required. Abbott is sending free replacements to affected users. A spokesperson for Abbott said via email the recall “may impact less than 1% of Libre 3 users in the U.S.” but did not specify the number of devices affected when asked. Dive Insight Abbott’s Freestyle Libre 3 CGM product consists of a wearable sensor, a reader and an app. The recall affects only the sensor component. Abbott has “received a small number of reports from consumers regarding the issue,” the spokesperson wrote. The company ...
- Source: drugdu
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- July 29, 2024
Integrity Partners With Gosen Insurance Group to Bring New Solutions to Hispanic Communities in Florida

By Mike Hollan The partnership will allow both group to expand their operations and provide more solutions to underserved communities. Integrity Marketing Group and Gosen Insurance Group are partnering to provide more benefit to underserved markets.1 Gosen is an independent insurance company located in Kissimmee, Florida, that focuses on providing Medicare solutions to the Hispanic community in the area. One of the company’s strengths is its ability to provide education of Medicare and coverage options in the native language of many of the community members. In a press release, Integrity CEO and co-founder Bryan W. Adams said, “Katiry and Alex embody a strong spirit of empathy, compassion, and service. They are true servant-leaders within the Hispanic community and bring a deep commitment to improve the lives of the clients and agents they serve. With Integrity’s world-class resources and groundbreaking technology alongside them, Katiry and Alex can support their diverse community ...
- Source: drugdu
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- July 29, 2024

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