COVID-19

‘Breakthrough’ treatment slashes coronavirus death risk: UK study

07/20/2020

Excerpt from the article: “An aerosol-based drug treatment could drastically reduce the number of new coronavirus patients dying from the disease or requiring intensive care, according to preliminary results released by a British biotech firm. In a randomised trial of 100 patients admitted to hospital with COVID-19, those who received an inhaled formula of the…

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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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Clinical Trial Shows Itolizumab Reduces Mortality in Patients Hospitalized with COVID-19

07/14/2020

Excerpt from the Press Release: “LA JOLLA, Calif., July 13, 2020 (GLOBE NEWSWIRE) — Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that as reported by its partner, Biocon Limited, a clinical trial conducted in India by Biocon demonstrated that itolizumab significantly reduced mortality…

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Wyss Institute gets $16M to repurpose FDA-approved drugs for Covid-19

07/01/2020

Excerpt from the article: “As the scientific community races toward potential treatments for Covid-19, the respiratory illness caused by the novel coronavirus that has now killed at least 116,000 Americans, researchers at Harvard’s Wyss Institute are partnering with institutions across the U.S. on a new project using old materials. The Wyss Institute has signed a…

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IncellDx Files Patent for CCL5/RANTES Utility as a Diagnostic, Prognostic, and Therapeutic Biomarker in COVID-19 and Other Cytokine Storm Conditions

06/30/2020

Excerpt from the press release: “SAN FRANCISCO–(BUSINESS WIRE)–IncellDx announces the patent filing with the USPTO and the Pre-EUA with the FDA for CCL5/RANTES Utility as a Diagnostic, Prognostic, and Therapeutic Biomarker in COVID-19. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of a novel coronavirus disease 2019 (COVID-19), is now a global pandemic.…

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4 Ways to Adapt your Inspection Readiness Framework in a Post COVID-19 World

06/29/2020

Excerpt from the article: “Although much has changed in the landscape of clinical trials because of COVID-19, the framework of inspection readiness planning and activities remains the same. It is however crucial to understand how the impacts of COVID-19 play a role in our preparation activities. Our recent Halloran Speaker Series, “Inspection Readiness Framework and…

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Gilead to start trial of inhaled version of Covid-fighting remdesivir

06/27/2020

Excerpt from the article: “Gilead Sciences Inc. is prepping to launch clinical trials of an inhaled form of its Covid-19-fighting drug remdesivir, a version that could expand access to the treatment and keep less-severe patients out of hospitals. Remdesivir is the only drug granted emergency use authorization from the Food and Drug Administration against the…

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SFA Therapeutics Receives Grant For Drug for Acute Respiratory Distress Syndrome In COVID-19

06/26/2020

Excerpt from the press release: “PHILADELPHIA – June 24, 2020 – PRLog — SFA Therapeutics, Inc. is pleased to announce receipt of a “Save Our Start-ups” (SOS) grant to study SFA005 in the treatment of cytokine storm linked to Acute Respiratory Distress Syndrome (ARDS), which has been experienced by patients infected with COVID-19. This grant…

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Fulcrum Therapeutics Announces Initiation of Multi-Center Phase 3 (LOSVID) Trial with Losmapimod for Hospitalized COVID-19 Patients

06/25/2020

Excerpt from the press release: “CAMBRIDGE, Mass., June 24, 2020 (GLOBE NEWSWIRE) — Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that it received early notification from the U.S. Food and Drug Administration (FDA) that the company may proceed with initiating…

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NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19

06/24/2020

Excerpt from the press release: “RADNOR, Pa. and GENEVA, June 24, 2020 (GLOBE NEWSWIRE) — NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track Designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute…

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