Clinical Trials & Research

INDIANAPOLIS, April 16, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) has requested the U.S. Food and Drug Administration (FDA) revoke the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg alone. Lilly made this request due to the evolving variant landscape in the U.S. and the full availability of bamlanivimab and etesevimab together. This request
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Researchers identified two potential drug candidates that can inhibit SARS-CoV-2 in vitro. Their combination can work synergistically and increase their inhibitory effect. Although several vaccines have now been approved to combat COVID-19, not enough is known about their efficacy against new variants of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Available treatments target the
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April 16, 2021 — Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the
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Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2
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April 13, 2021 — A clinical trial testing the safety and efficacy of an investigational monoclonal antibody for treating people who are hospitalized with respiratory disease and low blood oxygen due to infection with SARS-CoV-2, the virus that causes COVID-19, has begun. The Phase 2 trial, called the COVID-19 anti-CD14 Treatment Trial (CaTT), is sponsored
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Some survivors of ebolavirus outbreaks make antibodies that can broadly neutralize these viruses–and now, scientists at Scripps Research have illuminated how these antibodies can disable the viruses so effectively. The insights may be helpful for developing effective therapies. Ebolavirus is a family of often-deadly viruses that includes Ebola virus and many lesser-known viruses such as
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News Clinical Trials Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing New Brunswick, NJ (April 3, 2021) – Johnson & Johnson is assuming full responsibility regarding the manufacturing of drug substance for its COVID-19 vaccine at the Emergent BioSolutions Inc. Bayview facility. Specifically, the Company is adding dedicated leaders for operations and quality, and significantly
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Initial clinical trials for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines excluded pregnant women. Thus, pregnant women’s immune response to vaccination and the transplacental transfer of maternal antibodies to the fetus is not yet studied in detail. Recently, a group of researchers analyzed 122 pregnant women and their neonates at the time of birth.
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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apr. 7, 2021– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today highlighted the publication of antibody persistence data out to 6 months following the second dose of the Moderna COVID-19 Vaccine in The New England Journal of Medicine. “We are pleased that this new data shows antibody persistence through 6 months following
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Psychosocial stress – typically resulting from difficulty coping with challenging environments – may work synergistically to put women at significantly higher risk of developing coronary heart disease, according to a study by researchers at Drexel University’s Dornsife School of Public Health, recently published in the Journal of the American Heart Association. The study specifically suggests
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Several randomized placebo-controlled Phase III trials have shown that messenger RNA (mRNA) vaccines for COVID-19 effectively prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, the effectiveness of these vaccines in preventing asymptomatic and symptomatic COVID-19 infections is not well understood. A new Morbidity and Mortality Weekly Report published by the U.S. Centers for
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NEW YORK & INDIANAPOLIS–(BUSINESS WIRE) March 25, 2021 — Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced the outcome of the U.S. Food and Drug Administration (FDA) Joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on tanezumab. There was a single voting question focused on whether the proposed
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In a methodologically ‘state-of-the-art’ approach, US researchers have developed a protein-based nanoparticle vaccine against coronavirus disease (COVID-19), with a swift generation of antibodies and the potential to protect individuals who cannot receive other COVID-19 vaccines for medical reasons. The research is posted to the bioRxiv* preprint server. Vaccines currently in use against the severe acute
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MADRID, SPAIN and CAMBRIDGE, MA, UNITED STATES, March 29th, 2021 - Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today the enrollment of the first patient in the PORTICO Phase IIb clinical trial with vafidemstat in Borderline Personality Disorder (BPD),
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Cancer is the world’s second deadliest disease which contributes towards the fatality of over 10 million people per year. Oncologists adopt a variety of treatment procedures to treat cancer cells. Among the different methods used to fight cancer, chemotherapeutic treatment is a prominent and well-adopted technique. It is a drug based method, wherein powerful chemical
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HOUSTON, March 30, 2021 /PRNewswire/ – Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its request for Fast Track Designation for its drug, Annamycin, for
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VANCOUVER, Washington, March 30, 2021 (GLOBE NEWSWIRE) – CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, is pleased to announce further results from its CD12 trial of severe-to-critically ill patients with COVID-19. Upon further statistical analysis of the critically
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As cancer survival rates improve, more people are living with the aftereffects of cancer treatment. For some patients, these issues include chronic radiation-induced skin injury – which can lead to potentially severe cosmetic and functional problems. Recent studies suggest a promising new approach in these cases, using fat grafting procedures to unleash the healing and
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PRINCETON, N.J.–(BUSINESS WIRE) March 25, 2021 — Bristol Myers Squibb (NYSE: BMY) today announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. The trial met its primary endpoint of progression-free
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London, UK 18 March 2021 – GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the first patient has been dosed in the SWIFT-2 trial as part of the phase 3 clinical programme investigating the safety and efficacy of GSK3511294 (“GSK’294”) in severe eosinophilic asthma (SEA). GSK’294 is an investigational medicine with potential to be the first biologic
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A study published in the Journal of Occupational and Environmental Medicine from researchers at Henry Ford Health System has found that Henry Ford’s early implementation of a universal mask policy in the COVID-19 pandemic was associated with reducing the risk of healthcare workers at Henry Ford acquiring COVID-19. Through retrospective analysis of an internal hospital
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78.4% of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment at Week 52 (p < 0.0001) 69.8% of women who continued relugolix combination therapy remained responders through Week 104 88.3% of women who discontinued treatment relapsed with
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