COVID-19

Ufovax Announces Its Self-Assembling NanoParticles as the Next-Generation Vaccine Solution for COVID-19

09/23/2020

Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–Ufovax, LLC, (Ufovax), a vaccine biotechnology company based on the patented One-component Self-Assembling protein NanoParticle® (1c-SApNP®) vaccine design and manufacturing platform invented by Associate Professor Jiang Zhu, PhD, of Scripps Research (La Jolla, CA), announced the advancement toward Phase I clinical trials of its next-generation SARS-CoV-2 (aka “COVID-19”)…

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New Coronascape tool will help unlock big-data insights for COVID-19

09/22/2020

Excerpt from the Article: Scientists at Sanford Burnham Prebys Medical Discovery Institute today announced they have released Coronascape (coronascape.org), a customized version of the Metascape bioinformatics platform that removes big-data analysis hurdles for biologists. Coronascape will enable scientists to interpret the growing body of big data related to COVID-19. More than 23,000 papers about COVID-19…

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Equillium Announces Successful Completion of FDA Pre-IND Meeting Enabling Advancement of Itolizumab into a Potential Registration Study as a Treatment for Hospitalized COVID-19 Patients

09/21/2020

Excerpt from the Press Release: LA JOLLA, Calif., Sept. 15, 2020 (GLOBE NEWSWIRE) — Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced it has completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP). The FDA provided…

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Ask Us Anything In Clinical Trials – Data Management Tools We Love and Hate To Use

09/20/2020

Our third episode in the Ask Us Anything In Clinical Trials virtual networking series. Heather and Christopher along with their guests dive into a discussion around the Data Management tools we love and hate to use, as well as how data management is changing under the evolving conditions brought on by the pandemic. If you…

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Illumina awarded NIH funding for COVID-19 test that runs 3,000 samples at once

09/11/2020

Excerpt from the Article: San Diego gene sequencing giant Illumina has secured government funding for a COVID-19 test that can detect the novel coronavirus in thousands of samples at once, according to an announcement this week from the National Institutes of Health. The NIH awarded nine companies a total of $129 million to develop rapid,…

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Vaxart’s Oral COVID-19 Vaccine Candidate Induces Potent Systemic and Mucosal Immune Responses in Preclinical Studies

09/10/2020

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) — Vaxart, Inc. (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced pre-publication of a manuscript titled “Preclinical studies of a recombinant adenoviral mucosal vaccine to prevent SARS-CoV-2 infection.”…

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Prominent biotech leaders release Covid-19 guidelines calling for FDA independence, data transparency

09/07/2020

Excerpt from the Article: WASHINGTON — A group of prominent biotech CEOs are calling on their peers and the federal government to hold themselves to the highest standards when it comes to developing and reviewing Covid-19 treatments. Among their demands: That biotech companies don’t simply release clinical trial data in press releases, and that federal…

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Translate Bio and Sanofi’s COVID-19 Vaccine Positive in Animal Studies

09/04/2020

Excerpt from the Article: In a regulatory filing with the U.S. Securities and Exchange Commission (SEC), Translate Bio indicated that the COVID-19 vaccine it is developing with Paris-based Sanofi induced an immune response in non-human studies. The companies expect to begin human clinical trials in November. On June 23, Sanofi Pasteur, the vaccines business unit…

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HiFiBiO Therapeutics Submits IND Application for Fully Human SARS-CoV-2 Neutralizing Antibody for the Treatment of COVID-19 Patients

09/03/2020

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–HiFiBiO Therapeutics, a multinational biotherapeutics company focused on the development of novel antibodies for immunomodulation, announced today the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a novel SARS-CoV-2 neutralizing antibody for the treatment of COVID-19 patients. The highly…

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Sorrento Announces FDA IND Filing Today for COVI-GUARD Neutralizing and High Potency Antibody Against SARS-CoV-2

08/28/2020

Excerpt from the Press Release: SAN DIEGO, Aug. 19, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced that it is filing an investigational new drug application (IND) for COVI-GUARD (STI-1499) for hospitalized COVID-19 patients today. Sorrento has previously received guidance from the FDA in response to a pre-IND meeting package and believes…

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