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Moderna Announces Initiation of Rolling Submission to Health Canada for mRNA Vaccine Against COVID-19 (mRNA-1273)

10/20/2020

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–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…

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PhaseBio Doses First Patient in VANGARD Phase 2 Clinical Trial to Evaluate PB1046 for Hospitalized COVID-19 Patients

07/19/2020

Excerpt from the press release: MALVERN, Pa. & SAN DIEGO–(BUSINESS WIRE)–Jul. 16, 2020– PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that it has dosed the first patient in VANGARD, a potentially pivotal Phase 2 clinical trial to evaluate PB1046…

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VITRAC Therapeutics Initiates a Phase 1/2 Clinical Trial with the Aurora Kinase A inhibitor VIC-1911 in GVHD Prophylaxis

05/05/2022

Excerpt from the Press Release: VITRAC Therapeutics, LLC (VITRAC) initiated a Phase 1/2 clinical trial of VIC-1911 in combination with sirolimus and post-transplant cyclophosphamide (PTCy) as graft-versus-host disease (GVHD) prophylaxis in myeloablative allogeneic stem cell transplantation. VIC-1911 is an oral selective Aurora kinase A inhibitor (AURKA). The trial is being carried out at the University…

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Promising Personalized Approach to Liver Cancer Therapy Made Possible by DNA-based Neoantigen Research Designed at The Wistar Institute

05/13/2024

Geneos Therapeutics, Wistar, and Collaborators Translate Personalized DNA Vaccine Technology into Clinical Outcome Based on Mistakes Tumors Make Excerpt from the Press Release: PHILADELPHIA — (Tuesday, April 30, 2024) — Hepatocellular carcinoma (HCC), or liver cancer, is an aggressive malignancy with limited treatment options. An immunologically cold cancer — meaning the tumors can effectively hide…

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Google Shows AI Can Spot Breast Cancer Better Than Doctors

01/06/2020

According to new research from Google Health, AI can more accurately detect breast cancer than physicians. “The technology’s reading of mammograms reduced both false positives, where healthy patients are mistakenly diagnosed with the disease, and false negatives, where the cancer is missed, the Alphabet Inc. unit said in a blog post on Wednesday. The system reduced false positives by…

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CN BIO and iiCON collaborate to validate novel Covid-19 research tools

12/02/2021

The Infection Innovation Consortium (iiCON) and organ-on-a-chip company (OOC) CN BIO have launched a research collaboration to validate the next generation of Covid-19 research tools. Excerpt from the Press Release: Led by the Liverpool School of Tropical Medicine (LSTM) iiCON is a £174 million programme that brings together industry, academia, and clinicals to accelerate the…

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Regulatory Compliance

04/28/2020

21 CFR Part 11 and HIPAA Compliant eClinical Suite Regulatory Compliance TrialStat’s entire Unified eClinical Suite is developed and deployed with an Agile Methodology and specifically engineered to comply with FDA 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures. TrialStat maintains a Master Validation Plan and Change Control procedures to control and…

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Sermonix Pharmaceuticals Announces Initiation of Phase 3 ELAINE-3 Study of Lasofoxifene Plus Abemaciclib in Pre- and Post-Menopausal Patients with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation as Detected by Guardant Health’s Guardant360 CDx Liquid Biopsy

03/15/2023

Excerpt from the Press Release: COLUMBUS, Ohio and PALO ALTO, Calif., March 09, 2023 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast and gynecological cancers harboring ESR1 mutations, and Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the initiation of…

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Cellworks Clinical Trial Results Presented at IASLC 2021 World Conference on Lung Cancer

09/16/2021

Personalized Therapy Biosimulation Identifies Novel Biomarkers that Predict Drug and Immunotherapy Response in Patients with NSCLC Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, today announced that results from patient stratification studies using the Cellworks Computational…

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PerkinElmer Releases New Dried Blood Spot Based COVID-19 Serology Test

07/30/2020

Excerpt from the Press Release: “WALTHAM, Mass.–(BUSINESS WIRE)–PerkinElmer, Inc. (NYSE:PKI), a global leader committed to innovating for a healthier world, today announced the launch of a dry blood spot (DBS) based test for SARS-CoV-2 IgG using its GSP®/DELFIA® platform, enabling processing of up to 5,000 samples per day. The finger-prick sample collection device allows for…

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