Clinical Trials & Research

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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Sponsored Content by EntegrisJun 15 2021 insights from industryMark BumillerTechnology Manager Entegris In this interview, Mark Bumiller, Technology Manager at Entegris talks to News Medical Life Sciences about the role nanoparticles can play in drug delivery. Could you give our readers some background on Entegris? With over 50 years of experience, Entegris is a global
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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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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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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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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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Medical distribution company Regional Health Care Group (RHCG) will now be bringing KA Imaging’s innovative X-ray technologies to Australia and New Zealand. This agreement ensures sole rights to RHCG as KA Imaging’s distributor. “This is a fantastic opportunity for KA Imaging that moves us towards fulfilling our vision of innovative X-ray everywhere. We are thrilled
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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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Along with humans, dogs and cats have tested positive for COVID-19 (coronavirus disease 2019). In spite of this, we don’t know for certain whether pets are involved in the transmission of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To date, SARS-CoV-2, the etiological agent of COVID-19 has infected over 173 million individuals and claimed
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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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The ongoing coronavirus disease 2019 (COVID-19) pandemic is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a highly contagious RNA virus. Scientists across the world have been working at record speed to develop vaccines such as Pfizer’s BNT162b2 vaccine and Moderna’s mRNA-1273 vaccine. Various regulatory bodies, including the U.S. Food and Drug Administration (FDA),
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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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Normal cells usually have multiple solutions for fixing problems. For example, when DNA becomes damaged, healthy white blood cells can use several different strategies to make repairs. But cancer cells may “put all their eggs in one basket,” getting rid of all backup plans and depending on just one pathway to mend their DNA. Cold
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Treatment with sotrovimab resulted in an 85% reduction in the risk of hospitalization or death in high-risk adult outpatients compared to placebo, based on interim results from Phase 3 COMET-ICE trial In vitro data indicate sotrovimab maintains activity against all known variants of concern, including the variant from India Sotrovimab will be available for appropriate
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A team of experts in post-stroke neurorehabilitation confirmed that including prism adaptation treatment in standard of care for patients with post-stroke spatial neglect improved functional and cognitive outcomes according to the Functional Independence Measure®. The article, “Prism Adaptation Treatment Improves Inpatient Rehabilitation Outcome in Individuals with Spatial Neglect: A Retrospective Matched Control Study” was published
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HONG KONG, May 24, 2021 /PRNewswire/ — On May 24, 2021, Akeso, Inc. (HKEx: 9926.HK) announced that Penpulimab (research and development code: AK105), an PD-1 monoclonal antibody drug co-developed by the Company with Sino Biopharmaceutical Limited (HKEx: 1177.HK), has submitted a Biologics License Application (“BLA”) to the Food and Drug Administration of the United States (“FDA”) for third-line treatment of metastatic nasopharyngeal
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A team of scientists from the Washington University, in St. Louis, USA, has recently conducted a survey to analyze factors responsible for coronavirus disease 2019 (COVID-19) vaccination hesitancy among US citizens. The study findings reveal that public willingness to vaccination can likely be improved by allowing them to select vaccine brands and locations. In contrast,
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May 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated data from the Phase 1 CHRYSALIS study showing treatment with amivantamab in combination with lazertinib led to a median duration of response (DOR) of 9.6 months in chemotherapy-naïve patients with non-small cell lung cancer (NSCLC) and epidermal growth factor
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It has been about 16 months since severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) appeared in Wuhan, China, but the relationship between immunity and clinical protection from SARS-CoV-2 is still unknown. Reliable predictive models of immune protection from infection are still unavailable. Models like these are essential in identifying correlates of protection for SARS-CoV-2 vaccinations
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MIAMI, May 19, 2021 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, today announced that it has enrolled the first patient in its Phase 3 clinical trial of sabizabulin, a novel, proprietary, oral cytoskeleton disruptor with anti-inflammatory and anti-viral properties, to
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An extremely rare syndrome has been reported in people who were vaccinated against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – blood clots occur at unexpected places in the body, accompanied by a low thrombocyte count and clotting disorder. Some vaccine recipients, especially after the administration of the ChAdOx1 nCOV-19 vaccine (the Oxford/AstraZeneca vaccine), developed
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