Month: March 2022

Seres Therapeutics Presents Preclinical Research on Investigational Microbiome Therapeutic SER-155 at the 2022 European Bone Marrow Transplantation Annual Meeting

03/28/2022

– Preclinical data demonstrate SER-155 reduces infection and Graft-versus-Host Disease – Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, will present preclinical findings tomorrow at the European Bone Marrow Transplantation (EBMT) Annual Meeting that suggest SER-155 works by targeting the host immune response, potentially allowing patients undergoing…

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Soligenix COVID-19 Vaccine, CiVax™, Boosts Neutralizing Activity against SARS-CoV-2, including Delta and Omicron

03/28/2022

CiVax™ booster vaccine administered seven months after primary vaccination with COVID-19 adenovirus vaccine shows rapid enhancement of neutralizing antibody responses in non-human primates Neutralizing antibodies against Delta and original strain increased by up to 27-fold within one week and up to 243-fold within three weeks Omicron neutralizing antibody levels were undetectable prior to booster vaccination, and…

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Eiger’s Single-dose Peginterferon Lambda for COVID-19 Reduced Risk of Hospitalization or ER Visits by 50% in a Predominantly Vaccinated Population in Phase 3 TOGETHER Study

03/25/2022

Second largest study to date in COVID-19 outpatients (N=1,936) Highly superior compared to placebo, with a probability of superiority of 99.91% on the primary endpoint 60% reduced risk of COVID-19-related death Primary endpoint achieved across multiple SARS-CoV-2 variants, including omicron Eiger plans to submit data to FDA for Emergency Use Authorization (EUA) Management to host…

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Biological Dynamics Study Demonstrates Detection of Early-Stage Cancers

03/25/2022

In a Nature Communications Medicine publication, the Verita™ proprietary platform detected 96 percent of stage 1 pancreatic cancers and three-quarters of stage 1 ovarian cancers using isolated exosomes and AI-enabled protein marker analysis Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Biological Dynamics, Inc. announces the publication of its study, Early-Stage Multi-Cancer Detection Using an Extracellular Vesicle…

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Ionis announces publication of positive Phase 2 data for donidalorsen in New England Journal of Medicine

03/25/2022

Treatment with donidalorsen in Phase 2 study significantly reduced angioedema attacks by 90% and provided improvement in quality of life Published findings demonstrate favorable safety and tolerability profile of donidalorsen in Phase 2 study Donidalorsen is one of Ionis’ wholly owned medicines the company plans to commercialize Excerpt from the Press Release: CARLSBAD, Calif., March…

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U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for EGFR Therapeutics Targeting Exon 19 Deletions or Exon 21 Substitutions in Non-Small Cell Lung Cancer

03/24/2022

Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as a companion diagnostic for a third group of targeted therapies Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. a pioneer in molecular profiling for cancer, today announced it has received approval from the U.S. Food and Drug…

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LYNPARZA® (olaparib) reduced risk of death by 32% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer

03/24/2022

First PARP inhibitor to demonstrate overall survival benefit in early breast cancer Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada, today announced further positive results from the OlympiA Phase III trial showed LYNPARZA® (olaparib) demonstrated a statistically significant and clinically meaningful improvement in…

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RESEARCH HIGHLIGHTS CHANGING FACTORS THAT INFLUENCE COLORECTAL CANCER SCREENING ADHERENCE

03/24/2022

– Freenome examines thirty years of studies to understand differences in predictors of adherence across care settings– Recent studies highlight increased awareness of patient environment and clinical site factors as key predictors of adherence Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., March 15, 2022 /PRNewswire/ — Freenome, a privately held biotech company, presented research at the American Society…

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Iovance Biotherapeutics’ Investigational New Drug Application (IND) Allowed to Proceed for TALEN®-Edited Tumor Infiltrating Lymphocyte (TIL) in Unresectable or Metastatic Melanoma and Stage III or IV Non-Small Cell Lung Cancer (NSCLC)

03/23/2022

Clinical Study Expected to Begin in 2022 to Investigate the Safety and Efficacy of IOV-4001 to Deliver TIL and PD-1 Inhibition within a Single Cancer Therapy First Genetically Modified Iovance TIL Therapy Leverages TALEN® technology Licensed from Cellectis to Inactivate PD-1 Expression Excerpt from the Press Release: SAN CARLOS, Calif., March 15, 2022 (GLOBE NEWSWIRE) — Iovance…

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Bladder EpiCheck® Included in 2022 European Association of Urology (EAU) Clinical Guidelines on Non-Muscle Invasive Bladder Cancer (NMIBC)

03/23/2022

Clinical Guidelines Support Adoption of Urinary Biomarker Tests with High Sensitivity and Negative Predictive Values for High-Grade Disease to Replace and/or Postpone Cystoscopies in Low- and Intermediate-Risk NMIBC Publication of Meta-Analysis in European Urology Oncology Showed Bladder EpiCheck has Best Performance Amongst Guideline-Recommended Urinary Biomarker Tests Excerpt from the Press Release: SAN DIEGO & REHOVOT,…

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