Clinical Trials & Research

INDIANAPOLIS, July 29, 2021 /PRNewswire/ – Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today the U.S. Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. The EUA now provides for
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A US-based study has recently compared the viral load in vaccinated and unvaccinated individuals who have been infected with the delta variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The findings reveal that vaccinated and unvaccinated individuals exhibit similar viral loads following delta infection and that vaccine breakthrough cases have the potential to transmit
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INDIANAPOLIS, July 29, 2021 /PRNewswire/ – Today at the Alzheimer’s Association International Conference© (AAIC© 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. In the first, greater amyloid plaque changes following donanemab treatment was highly associated with less cognitive decline and participants with greater plaque clearance at 24 weeks
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It’s a scientific riddle tangled up in a complex web. How do you turn an immune cold cancer into one that responds to immunotherapy? Researchers led by the University of Michigan Rogel Cancer Center started with a simple thread: an inhibitor that showed promise against metastatic castration-resistant prostate cancer cells. This is the most challenging
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TARRYTOWN, N.Y., July 30, 2021 /PRNewswire/ – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for the investigational COVID-19 antibody cocktail REGEN-COV™ (casirivimab and imdevimab). The authorization now includes post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not
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As vaccination efforts against the coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continue globally, scientists and public health officials are dealing with the threat of breakthrough infections. Scientists call such cases “breakthrough” infections because the virus has broken through the protective barrier provided by the vaccine. A new study
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7 in 10 UK chronic pain sufferers delayed seeking medical advice during the COVID-19 pandemic, leaving them feeling increased levels of stress, anxiety and worry, new research from Boston Scientific has revealed. The research, which surveyed 502 UK chronic pain sufferers (those who suffer from continuous and long-term pain lasting more than 12 weeks), as
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Hydrogen peroxide reacts with copper to produce hydroxyl radicals with strong antibacterial properties. However, this requires high copper concentrations because two copper atoms have to come close together, which occurs by chance. Now, scientists at Tokyo University of Science, Japan, engineered a long polymer with copper-containing side units that create regions with locally high copper
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The London Ophthalmology Centre (LondonOC) has developed a new, non-invasive technique for the application of Xen stent into the eye to treat acute glaucoma. The micro device and new technique was successfully used to save the sight of former Children’s Laureate, Michael Rosen. Image Credit: London Ophthalmology Centre Mr Vik Sharma (MBBS BSc FRCOphth), Clinical
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Since the US Food and Drug Administration (FDA) established its accelerated approval pathway for drugs in 1992, nearly half (112) of the 253 drugs authorized have not been confirmed as clinically effective, an investigation by The BMJ has found. Elisabeth Mahase, clinical reporter at The BMJ, carried out an in depth analysis of FDA data
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Johns Hopkins Medicine researchers, in collaboration with national and international researchers, have identified a genetic mutation in a small number of children with a rare type of inflammatory bowel disease. The discovery of the mutation, which weakens the activity of a protein linked to how the immune system fights viruses in the gut, may help
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Membrane proteins are heavily involved in a variety of cellular processes such as signal transduction, membrane translocation, cell adhesion, and many more, and therefore are of great interest within the field of drug design. The structure of relevant membrane proteins is sometimes mimicked during research using detergent micelles, which are capable of entrapping and extracting
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SOUTH SAN FRANCISCO, Calif., July 28, 2021 (GLOBE NEWSWIRE) – Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced randomization of the first subject in its SUMMIT Phase 3 efficacy trial of STS101 for the acute
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News Clinical Trials Johnson & Johnson Statement on U.S. FDA Approval of Shelf Life Extension for Company’s COVID-19 Vaccine NEW BRUNSWICK, N.J., July 28, 2021 – We are pleased to confirm the U.S. Food & Drug Administration (FDA) has extended the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine to six months. The decision
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Researchers in the United States have demonstrated the efficient aerosol transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – the agent that causes coronavirus disease 2019 (COVID-19) – in a hamster model. The team from the National Institute of Allergy and Infectious Diseases in Hamilton, Montana, specifically designed novel transmission cages to investigate aerosol
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Virginia Tech scientists with the Fralin Biomedical Research Institute at VTC have identified neural learning processes to be associated with symptoms of depression and linked improvements in these processes to improved symptoms in research participants being treated for depression. The findings, described in a study published today (11 a.m. July 28, 2021) in the Journal
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As of July 28, 2021, more than 195 million people have been infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) worldwide. This ribonucleic acid (RNA) virus, which is the cause of the coronavirus disease 2019 (COVID-19), has claimed more than 4.17 million lives around the world. Study: Change in Symptoms and Immune Response in
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WILMINGTON, Del.–(BUSINESS WIRE) July 23, 2021 — Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the
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23 July 2021 Real-world data from Canada showed 82% and 87% effectiveness after one dose against hospitalisation or death caused by Beta/Gamma and Delta variants respectively  Results from the Canadian Immunization Research Network (CIRN) with support from Public Health Agency of Canada and the Canadian Institutes of Health Research, published as a pre-print, demonstrated one dose
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Two types of drugs that are recommended as a first treatment for patients with high blood pressure were found equally effective in improving cardiovascular outcomes, but the more popular type causes slightly more side effects, finds a multinational observational study led by researchers at Columbia University Vagelos College of Physicians and Surgeons. The study, which
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NORTH CHICAGO, Ill., July 25, 2021 /PRNewswire/ — Allergan, an AbbVie (NYSE: ABBV) company, today announced new data, including the full results from the Phase 3 GEMINI 1 clinical study, evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. Multiple data presentations at the 2021 ASCRS (American Society
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Scientists from the United States have recently estimated the prevalence of vaccine breakthrough cases caused by the delta variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Their findings reveal that about 58% of all new coronavirus disease 2019 (COVID-19) cases are due to the delta variant and that the prevalence of vaccine breakthrough cases
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A form of gene therapy protects optic nerve cells and preserves vision in mouse models of glaucoma, according to research supported by NIH’s National Eye Institute. The findings suggest a way forward for developing neuroprotective therapies for glaucoma, a leading cause of visual impairment and blindness. The report was published in Cell. Glaucoma results from
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Mount Sinai researchers have developed a therapeutic agent that shows high effectiveness in vitro at disrupting a biological pathway that helps cancer survive, according to a paper published in Cancer Discovery, a journal of the American Association for Cancer Research, in July. The therapy is an engineered molecule, named MS21, that causes the degradation of
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