Clinical Trials & Research

NEWTON, MA –June 10, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced that following a recent Type B meeting with the U.S. Food and Drug Administration (FDA) regarding Acer’s proposed Edsivo™
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According to researchers at Johns Hopkins Medicine, the Massachusetts Institute of Technology (MIT) and Rice University in Houston, silicone breast implants with a smoother surface design have less risk of producing inflammation and other immune system reactions than those with more roughly textured coatings. Results of the experiments using mice, rabbits and samples of human
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New vaccine based on the recombinant spike protein antigen (rS-B.1.351) from Beta (B.1.351) virus lineage highly immunogenic in mice and produced neutralizing antibodies Primates boosted with rS-B.1.351 vaccine induced strong neutralizing immune response to original SARS-CoV-2, Alpha (B.1.1.7) and Beta (B.1.351) variant strains Humans immunized with original NVX-CoV2373 vaccine demonstrated robust antibody responses to original
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Understanding cellular metabolism – how a cell uses energy- could be key to treating a wide array of diseases, including vascular diseases and cancer. While many techniques can measure these processes among tens of thousands of cells, researchers have been unable to measure them at the single-cell level. Researchers at the University of Chicago’s Pritzker
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93% efficacy against predominantly circulating Variants of Concern and Variants of Interest 91% efficacy in high-risk populations 100% efficacy against variants “not considered Variants of Concern/Interest” All COVID-19 hospitalizations/death occurred in the placebo group Company to host investor conference call today at 8:30 am ET GAITHERSBURG, Md., June 14, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq:
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COVID-19 vaccine candidate efficacy in those 18 to <65 years old was preserved in influenza vaccine recipients Influenza vaccine immunogenicity preserved Study demonstrated no early safety concerns Data available ahead of publication via preprint server, medRxiv  GAITHERSBURG, Md., June 14, 2021 /PRNewswire/ – Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced
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Several viruses such as severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome-CoV (MERS-CoV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) belong to the coronaviridae family of enveloped, positive-strand RNA viruses which infect amphibians, birds, and mammals. The causative agent of the ongoing coronavirus disease 2019 (COVID-19) pandemic is SARS-CoV-2. Despite many similarities,
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PARIS – June 11, 2021 – Results from Part A of CADENZA, a pivotal Phase 3 double-blind, placebo-controlled study evaluating the safety and efficacy of sutimlimab in people with cold agglutinin disease (CAD) without a recent history of blood transfusion (within the prior six months), will be presented in an oral session at the European Hematology
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In a recent study, Indian researchers from the Department of Biochemistry, University of Delhi, reviewed a possible vital coalition of FoxOs – the Forkhead Box O subfamily of protein transcription factors, with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the etiological agent of COVID-19 (coronavirus disease). This review work is posted in the journal, Open
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TARRYTOWN, N.Y., June 4, 2021 /PRNewswire/ –  EUA supported by pivotal Phase 3 data showing 1,200 mg dose reduced risk of hospitalization or death by 70% Only antibody therapy currently available in all 50 states, including eight states with high rates of two variants of concern Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and
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The term “doomscrolling” describes the act of endlessly scrolling through bad news on social media and reading every worrisome tidbit that pops up, a habit that unfortunately seems to have become common during the COVID-19 pandemic. The biology of our brains may play a role in that. Researchers at Washington University School of Medicine in
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KENILWORTH, N.J.–(BUSINESS WIRE) June 9, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced it has entered into a procurement agreement with the United States government for molnupiravir (MK-4482). Molnupiravir is currently being evaluated in a Phase 3 clinical trial, the MOVe-OUT study, for the treatment of non-hospitalized
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Two-stage design will evaluate vaccine formulations targeting original D.614 virus as well as B.1.351 variant, in diverse geographies with multiple circulating variants A booster study programme will begin in the coming weeks to complement the Phase 3 trial Pending positive Phase 3 outcomes and regulatory reviews, the vaccine could be approved in Q4 2021 London
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Researchers at the University of Sydney’s Charles Perkins Centre conducted the largest ever study of nutrient interactions by examining the health of mice on 33 different diets containing various combinations of protein to carbs, and different sources of carbohydrate. They found that a low-protein (10% of dietary energy), high-carbohydrate (70%) diet produced either the healthiest
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June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma. This distinction for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen
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The U.S. Food and Drug Administration (FDA) has approved Wegovy (semaglutide) injection (2.4 mg once weekly) as a chronic weight management treatment in obese or overweight adults with a weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol) when used along with calorie restriction and physical activity. Wegovy, is a more
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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jun. 1, 2021– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age
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A new global review has found that receiving Opioid Agonist Therapy (OAT) is associated with lower risk of multiple causes of death among people with opioid dependence. The review found that people with opioid dependence were less likely to experience overdose-related, suicide, alcohol-related, cancer, and cardiovascular-related mortality while receiving OAT. Researchers from the National Drug
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NEW YORK–(BUSINESS WIRE) May 24, 2021– Pfizer Inc. (NYSE: PFE) today announced that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the coadministration of the company’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, currently
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More than 170 million people have already been affected by the coronavirus pandemic known as Coronavirus disease 2019 (COVID-19). The causative agent of COVID-19 is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a highly infectious positive-stranded RNA virus. Scientists have found that this virus severely affects primarily older patients with comorbidities, including diabetes, chronic lung
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Primary endpoint of non-inferior immunogenicity versus the Phase 3 study adult comparator group was met No cases of COVID-19 observed after two doses of vaccine using the primary case definition, consistent with a vaccine efficacy of 100% Safety and tolerability generally consistent with Phase 3 COVE study in adults; no significant safety concerns identified Company
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To mark World Vape Day, BAT has today published a comprehensive review of the scientific evidence for vaping products (e-cigarettes), their potential health effects and their role in Tobacco Harm Reduction. This review shows that, over the past decade, the number of people who incorrectly believe vaping is as harmful or more harmful than smoking
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ROCKVILLE, Md.–(BUSINESS WIRE)–May 26, 2021– GlycoMimetics, Inc. (Nasdaq: GLYC) announced today that clinicians at Washington University School of Medicine in St. Louis have dosed the first patient in an investigator-sponsored trial (IST) evaluating uproleselan as a prophylactic agent to reduce gastrointestinal (GI) toxicities associated with high-dose melphalan in autologous hematopoietic cell transplantation (auto-HCT) for multiple myeloma (MM). Dr. Keith Stockerl-Goldstein, M.D., Professor
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Poor sleep impacts the risk of long-term cognitive decline in Hispanic/Latino middle aged and older adults differently than it does in non-Hispanic adults, according to research led by University of Miami Miller School of Medicine neurology faculty and the largest long-term study of U.S. Hispanic/Latinos to date. During seven years of follow-up, Hispanics/Latinos were more
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