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EU regulators expand use of remote source data verification in clinical trials

02/16/2021

Excerpt from the Article: The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials. Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few…

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Elicio Therapeutics Presents Preclinical Data on AMP-CpG Adjuvant in Combination with EBV Vaccine at the 2022 Keystone Symposia: Viral Immunity: Basic Mechanisms and Therapeutic Applications

07/12/2022

BOSTON, July 06, 2022 (GLOBE NEWSWIRE) — Elicio Therapeutics, a clinical stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, today announced that it presented preclinical data demonstrating its Amphiphile (AMP) platform adjuvant AMP-CpG combined with cell surface-associated viral protein EBV gp350 and EBVpoly protein, which elicits a…

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Astria Therapeutics Announces Publication of STAR-0215 Preclinical Data in the Journal of Pharmacology and Experimental Therapeutics

09/05/2023

Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and immunological diseases, today announced that preclinical data supporting STAR-0215’s profile as a potential long-acting therapy for hereditary angioedema (HAE) dosed once every three…

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Glyscend Therapeutics Announces Initiation of Phase 1 Clinical Trial on the Heels of Preclinical Data Presented at EASD 2021 on the Metabolic Benefits of its Oral Polymer-based Duodenal Exclusion Therapy

10/05/2021

Phase 1 clinical trial currently underway in Australia investigating a noninvasive, oral polymer therapy that dramatically improves glucose homeostasis with weight loss in nonclinical models. Excerpt from the Press Release: BALTIMORE & BOSTON–(BUSINESS WIRE)–Glyscend, Inc. delivered an oral presentation highlighting preclinical data from a study of its oral proprietary polymer duodenal exclusion therapy during the…

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Recor Medical Announces Positive Results from Six-Month Pooled Analysis of Data from the RADIANCE Global Clinical Trial Program at TCT 2023

11/06/2023

Analysis shows a maintained blood pressure lowering effect with fewer added medications following treatment with the Paradise Ultrasound Renal Denervation system Excerpt from the Press Release: PALO ALTO, Calif.–(BUSINESS WIRE)–Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced positive results from a combined analysis of six-month…

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Summit Therapeutics Presents Breakthrough Research Data from Phase II Studies, including Evidence Validating Microbiome Preservation, for its Investigational Drug Ridinilazole

07/27/2021

Excerpt from the Press Release: Cambridge, MA, July 12, 2021 (GLOBE NEWSWIRE) — Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit” or the “Company”) is today displaying three preeminent ePosters at the prestigious 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). Two ePosters bring increased awareness and understanding of the significance of data generated using…

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New Data Suggest Veracyte’s Envisia Genomic Classifier Can Help Predict Disease Progression in Interstitial Lung Disease Patients Treated with Combination Immunosuppressive Therapy

09/09/2022

Findings presented at the European Respiratory Society International Congress 2022 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT) today announced new data suggesting that the Envisia Genomic Classifier (EGC) can help predict which patients with interstitial lung disease (ILD), including idiopathic pulmonary fibrosis (IPF), are likely to have progressive disease…

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Sight Sciences Announces Publication of Clinical Data Demonstrating Standalone Effectiveness of the OMNI® Surgical System in Pseudophakic Glaucoma Patients with Uncontrolled Pressure Following a Previous Combination Cataract Stent Procedure

11/11/2022

Multicenter Clinical Data from Five US sites Published in International Ophthalmology Excerpt from the Press Release: Worldwide, more than one million trabecular microbypass stents have been implanted in combination with cataract surgery. Despite glaucoma medications and prior microbypass stenting, target IOP may no longer be achieved over time. During 3 to 42 months follow-up, the…

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Gritstone Announces First Patient Enrolled for Phase 2/3 Trial Evaluating Individualized Neoantigen Vaccine GRANITE for First Line (1L) Maintenance Treatment of Metastatic, Microsatellite-Stable Colorectal Cancer (MSS-CRC)

01/18/2022

— Phase 2/3 GRANITE-CRC-1L trial has registrational intent — — Updated data from Phase 1/2 trial in end-stage metastatic MSS-CRC further support the association of circulating tumor DNA (ctDNA) reduction with extended overall survival — — GRANITE has received Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS-CRC –…

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Annovis Bio Announces New Data from Phase III Parkinson’s Study Highlighting Improvements in Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and Cognition after Treatment with Buntanetap

07/09/2024

Excerpt from the Press Release: MALVERN, Pa., July 02, 2024 (GLOBE NEWSWIRE) — via IBN — Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), today announced new data from its Phase III PD…

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