Clinical Trials & Research

Reviewed by Emily Henderson, B.Sc.Oct 19 2020 The Columbia River is home to one of the West Coast’s most important Chinook salmon runs. Through late spring and early summer, mature fish return from the sea and begin their arduous journey upriver to spawn. In recent years, these fish have faced an additional challenge: hungry California
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SOUTH SAN FRANCISCO, Calif., Oct. 13, 2020 (GLOBE NEWSWIRE) – Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, today announced that the first subject has been dosed in its Phase 1 study of VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate. “We are advancing VXA-CoV2-1 into clinical development
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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct. 13, 2020– Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the initiation of a rolling submission to Health Canada for mRNA-1273, the Company’s vaccine candidate against COVID-19. This initiation follows positive results from a preclinical viral challenge study of
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Reviewed by Emily Henderson, B.Sc.Oct 15 2020 To date, a few verified repeat SARS-CoV-2 infections have been documented around the world. Should reinfection [with SARS-CoV-2] prove commonplace, and barring a highly effective vaccine delivered to most of the world’s population, SARS-CoV-2 will likely become endemic.” Jeffrey Shaman & Marta Galanti, Department of Environmental Health Sciences,
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October 13, 2020 — The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and merit advancement into larger clinical trials. The ACTIV-5 Big Effect Trial, which
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Reviewed by Emily Henderson, B.Sc.Oct 13 2020 As vaccine trials progress and public health officials brace for a rise in COVID-19 cases, understanding how the body defends itself from SARS-CoV-2 infection is essential. New research, published in Clinical and Translational Immunology, provides a clearer picture of the protective antibodies induced by this virus and their
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06 October 2020 — Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) study evaluating VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization. VIR-7831 (also
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Reviewed by Emily Henderson, B.Sc.Oct 9 2020 Rural emergency departments often lack the medical specialists who staff larger, urban hospitals. Yet rural patients have the same conditions–and need the same prompt care–that people in cities do. West Virginia University researcher Scott Findley has received a $1.2 million grant from the Health Resources and Services Administration–a
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NEW YORK and MAINZ, GERMANY, October 6, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19. The EMA’s decision to start a rolling review follows the encouraging preliminary
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Reviewed by Emily Henderson, B.Sc.Oct 9 2020 The University of Minnesota Medical School’s Department of Laboratory Medicine and Pathology has been selected to participate in a new national network dedicated to serological, or antibody, sciences as one of four Capacity Building Centers in the country. As part of the Serological Sciences Network (SeroNet), the team
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NEW YORK & BRISBANE, Calif.–(BUSINESS WIRE) October 07, 2020 — Pfizer Inc. (NYSE: PFE) and Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, today announced that the first participant has been dosed in the Phase 3 AFFINE study of giroctocogene fitelparvovec (SB-525), an investigational gene therapy for hemophilia A patients. AFFINE is a global
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THOUSAND OAKS, Calif., Oct. 5, 2020 /PRNewswire/ – Amgen (NASDAQ: AMGN) today announced positive topline Phase 2 results from the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 126 patients with KRAS G12C-mutant advanced non-small cell lung cancer (NSCLC), who had failed a median of two prior lines of anti-cancer therapies (immunotherapy and/or chemotherapy). Sotorasib demonstrated an
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Serological antibody immunoassays are one of the essential tools to combat severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In a new study, Immunoglobulin G (IgG) antibodies are detected in a large cohort, lasting up to 140 days. The researchers propose an alternative to reverse transcription-polymerase chain reaction (RT-PCR) positive status as a standard for
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Print this page CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sep. 29, 2020– Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the publication of the second interim analysis of the open-label Phase 1 study of mRNA-1273, its vaccine candidate against COVID-19, in The New
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Oct 2 2020 Global glass primary packaging supplier SGD Pharma has expanded its ready-to-use (RTU) molded glass vial range to introduce a market-first 50ml volume option in tray developed at industrial scale by a molded glass manufacturer. The Sterinity platform, which includes both ISO and EasyLyo injectable vials, offers high-quality sterile Type I molded glass
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Print this page SEATTLE, Sept. 29, 2020 /PRNewswire/ – CTI BioPharma Corp. (Nasdaq: CTIC) today announced that following a recent Pre-NDA meeting with the U.S. Food and Drug Administration (“FDA” or “the Agency”), the Company has reached an agreement to submit an NDA for the potential accelerated approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet count
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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection causes coronavirus disease 2019 (COVID-19), which manifests with pulmonary symptoms that show up as diffuse alveolar damage (DAD), pneumocyte hyperplasia and proliferation, excess inflammation, and platelet aggregate or thromboemboli formation in histological studies.  The mechanisms behind these histological findings are still unclear. Previous studies published on PubMed
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Print this page PLYMOUTH MEETING, Pa., Sept. 28, 2020 /PRNewswire/ — INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company’s
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Nine months into the coronavirus pandemic, the global case toll has now topped 33 million, with over one million deaths. As the global health crisis continues to wreak havoc, scientists are finding more links between underlying medical conditions and severe coronavirus disease (COVID-19). A team of researchers at the Universitas Indonesia in Jakarta, Indonesia, has
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Print this page GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) – Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK),
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Reviewed by Emily Henderson, B.Sc.Sep 26 2020 A novel mobile health program created in early 2018 by the Kraft Center for Community Health at Massachusetts General Hospital (MGH) has proven to be an effective model for bringing opioid addiction treatment services directly to marginalized individuals, particularly the homeless, a population that faces the highest risk
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Print this page TOKYO — September 23, 2020 FUJIFILM Toyama Chemical Co., Ltd. (President: Junji Okada; hereinafter “FUJIFILM Toyama Chemical”) has announced today that primary endpoint has been met in phase III clinical trial of “Avigan Tablet” (generic name: favipiravir, “Avigan”) conducted in Japan for patients with novel coronavirus infections (hereinafter “COVID-19”). The efficacy primary
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Reviewed by Emily Henderson, B.Sc.Sep 24 2020 Researchers have identified two antibodies that protect mice against lethal infections of influenza B virus, report scientists at Washington University School of Medicine in St. Louis and Icahn School of Medicine at Mount Sinai. Together with an antibody that targets the other major kind of influenza viruses that
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Print this page NEW BRUNSWICK, N.J., September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a
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Print this page Tokyo, Basking Ridge, N.J. and Munich – (September 14, 2020) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that the first patient has been dosed in a phase 2 study evaluating patritumab deruxtecan (U3-1402), a HER3 directed DXd antibody drug conjugate (ADC), in patients with advanced or metastatic colorectal cancer who
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