Clinical Trials & Research

A recent study conducted at the University of Texas at Austin, USA, has identified a highly conserved neutralizing antibody binding site on the spike S2 domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The study findings might help develop novel spike-targeting antibodies for widespread protection. The study is currently available on the bioRxiv* preprint

NEW BRUNSWICK, N.J., January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783

Researchers have created a dataset of COVID-19 patients with acute respiratory distress syndrome to help characterize lung compliance and hypoxemia, which may help administer better treatments. The severity of COVID-19, the disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), ranges from no symptoms in some patients to severe disease, including death in

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older. Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines

SORLA is a protein trafficking receptor that has been mainly studied in neurons, but it also plays a role in cancer cells. Professor Johanna Ivaska’s research group at Turku Bioscience observed that SORLA functionally contributes to the most reported therapy-resistant mechanism by which the cell-surface receptor HER3 counteracts HER2 targeting therapy in HER2-positive cancers. Removing

THOUSAND OAKS, Calif., Jan. 28, 2021 /PRNewswire/ – Amgen (NASDAQ: AMGN) today announced results from the Phase 2 cohort of the CodeBreaK 100 clinical study evaluating investigational sotorasib (AMG 510) in 126 patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). The results will be presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC)

A new University of California, Irvine-led study finds a new method for identifying biomarkers may aid in early cancer diagnosis. The study focused on lung cancer, however the Cell Heterogeneity-Adjusted cLonal Methylation (CHALM) method has been tested on aging and Alzheimer’s diseases as well and is expected to be effective for studying other diseases. “We

INDIANAPOLIS, Jan. 26, 2021 /PRNewswire/ – Bamlanivimab (LY-CoV555) 2800 mg and etesevimab (LY-CoV016) 2800 mg together significantly reduced COVID-19-related hospitalizations and deaths (collectively, “events”) in high-risk patients recently diagnosed with COVID-19, meeting the primary endpoint of the Phase 3 BLAZE-1 trial, Eli Lilly and Company (NYSE: LLY) announced. Across 1,035 patients, there were 11 events (2.1 percent) in

Researchers in Scotland have conducted a study showing that the proportion of deaths due to coronavirus disease 2019 (COVID-19) resulting from infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) increased in the UK after November 2020. The analysis showed that throughout October and November 2020, the death rate was 1 in 55 cases detected

London, UK — 16 January 2021 GlaxoSmithKline (GSK) plc announced updated data from GARNET cohort F evaluating dostarlimab in mismatch repair-deficient (dMMR) non-endometrial advanced solid cancers being presented today at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). Study results (abstract #9) showed a 38.7% objective response rate (ORR) (N=106, 95% CI;

Patients with acute myeloid leukemia (AML), the most common form of acute leukemia in adults, that has gone into remission following initial chemotherapy remain in remission longer and have improved overall survival when they are given a pill form of the cancer drug azacitidine as a maintenance treatment, according to a randomized, international phase 3

New York and Mainz, Germany, January 20, 2021 — Today, Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced results from an in vitro study that provides additional data on the capability of sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine BNT162b2 to neutralize the SARS-CoV-2 U.K. strain, also known as B.1.1.7 lineage or VOC 202012/01. The results were published

Researchers in the UK have conducted a study assessing the efficacy of the  Pfizer-BioNTech COVID-19 vaccine BNT162b2 against the new variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – the agent that causes coronavirus disease 2019 (COVID-19). The new B.1.1.7 variant, which has higher transmission potential than previous SARS-CoV-2 strains, recently emerged in the

The Woodlands, Texas, January 14, 2021 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it has received U.S. Food and Drug Administration (FDA) regulatory feedback that the results of its SOLOIST and SCORED Phase 3 clinical studies can support a new drug application (NDA) submission for an indication to reduce the risk of cardiovascular death,

In an exciting, state-of-the-art study currently available on the medRxiv* preprint server, US researchers created a multi-coronavirus protein microarray containing full-length proteins, peptide libraries, and overlapping protein fragments from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as well as four other human coronaviruses. They demonstrated that this technology could be used for mapping antibody

LUXEMBOURG, Jan. 17, 2021 /PRNewswire/ – Steba biotech, pioneering developer of the IMmune Photo Activate Cancer Treatment (ImPACT), announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for padeliporfin ImPACT for the treatment of adult patients with low-grade and unifocal high-grade Upper Tract Urothelial Cancer (UTUC). This swiftly follows clearance of the Investigational New Drug (IND) application granted in December 2020 allowing

Researchers in the Netherlands, the United States, and Belgium have presented early-stage clinical trial results demonstrating the safety and efficacy of Johnson & Johnson’s vaccine candidate for coronavirus disease 2019 (COVID-19). Phase 1–2a interim results show that the vaccine is safe and immunogenic in both younger and older adults after just a single dose, thereby

RADNOR, Pa.–(BUSINESS WIRE) January 13, 2021– Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has received a positive response from the U.S. Food and Drug Administration (FDA) that the efficacy and safety data resulting from the company’s pivotal Phase 3

A recent study conducted by a team of international scientists has revealed that the infectivity and pathogenicity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strongly depend on the genetic background of both the virus and the host. The study is currently available on the bioRxiv* preprint server. Background Since its emergence in December 2019,

SOUTH SAN FRANCISCO, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) – Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC®) targets

Researchers evaluating whether an investigational oral drug, vadadustat, can help prevent acute respiratory distress syndrome (ARDS) in COVID-19 patients were awarded $5.1 million in funding from the U.S. Department of Defense (DOD) to expand the Phase II clinical trial at The University of Texas Health Science Center at HoustonQ (UTHealth). Vadadustat is an investigational oral

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jan. 12, 2021– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. The authorization is given according to the ordinary approvals procedure and is based on a rolling submission of data and the totality of

Development of an in vitro human-derived tissue model for studying virus infection and disease progression in the alveolar cells of the lungs responsible for oxygen and carbon dioxide exchange with the blood might enable the study of possible therapies for acute respiratory distress syndrome (ARDS) triggered by SARS-CoV-2. Researchers in the Netherlands have demonstrated that

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jan. 4, 2021– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today provided a supply update for the Moderna COVID-19 Vaccine, increasing its base-case global production estimate from 500 to 600 million doses for 2021. Moderna said it is continuing to invest and add staff to build up to potentially 1

COVID-19 patients admitted to intensive care in the early months of the pandemic were subject to a significantly higher burden of delirium and coma than is typically found in patients with acute respiratory failure. Choice of sedative medications and curbs on family visitation played a role in increasing acute brain dysfunction for these patients. That’s

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jan. 6, 2021– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union. The authorization is based upon the recommendation of the European Medicines Agency (EMA)

Proteogenomic analysis may offer new insight into matching cancer patients with an effective therapy for their particular cancer. A new study identifies three molecular subtypes in head and neck squamous cell carcinoma (HNSCC) that could be used to better determine appropriate treatment. The research led by Baylor College of Medicine, Johns Hopkins University and the

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. The vaccine was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more