Infectious Diseases

Twist Bioscience Announces Potent SARS-CoV-2 Neutralizing Data from COVID-19 Therapeutic Antibody Program

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Twist Bioscience Corporation (Nasdaq: TWST) today announced data demonstrating the potent neutralizing effects of multiple potential therapeutic antibodies, both Immunoglobulin G (IgG) antibodies and substantially smaller single domain VHH “nanobodies,” against SARS-CoV-2, the virus that causes COVID-19. These neutralizing effects were found to be comparable to …

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Sanofi provides update on Kevzara Phase 3 trial in severe and critically ill COVID-19 patients outside the US

PARIS  – September 1, 2020 – Sanofi today announced that the global Phase 3 trial investigating intravenously administered Kevzara® (sarilumab) at a dose of 200 mg or 400 mg[a]  in severely or critically ill[b]  patients hospitalized with COVID-19 did not meet its primary endpoint and key secondary endpoint[c] when Kevzara was compared to placebo added to …

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Development of COVID-19 Vaccine AZD1222 Expands Into US Phase 3 Clinical Trial Across All Adult Age Groups

WILMINGTON, Del.–(BUSINESS WIRE)–AZD1222 development expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity.1 The US trial, called D8110C00001, is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the …

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Gilead’s Investigational Antiviral Veklury Receives FDA Emergency Use Authorization for Treatment of Patients with Moderate COVID-19

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) enabling use of the investigational antiviral Veklury® (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19. The …

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Guardant Health Receives FDA Emergency Use Authorization for its Guardant-19 Next Generation Sequencing-Based COVID-19 Test

REDWOOD CITY, Calif., Aug. 24, 2020 (GLOBE NEWSWIRE) — Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has granted the Guardant-19 test emergency use authorization (EUA) for use in the detection of the novel coronavirus, SARS-CoV-2. The test is being offered to Guardant Health employees …

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Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today shared additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. The newly released manuscript describes key safety and immunogenicity data …

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Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies, Starting with Treatments for COVID-19 and Cancer

SAN DIEGO AND BOSTON, Aug. 20, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) and SmartPharm Therapeutics, Inc. (“SmartPharm”) announced today the signing of a merger agreement under which Sorrento will acquire SmartPharm, a gene-encoded therapeutics company developing non-viral DNA and RNA gene delivery platforms for COVID-19 and …

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Roche and Regeneron Collaborate to Significantly Increase Global Supply of REGN-COV2 Investigational Antibody Combination for COVID-19

Basel, 19 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) and Regeneron (NASDAQ: REGN) announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe. REGN-COV2 could provide a much-needed treatment option …

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FDA Issues Emergency Use Authorization to Yale School of Public Health for its SalivaDirect COVID-19 Diagnostic Test

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection. “The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another …

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Gilead Submits New Drug Application to the FDA for Veklury (Remdesivir) for the Treatment of COVID-19

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Veklury® (remdesivir), an investigational antiviral for the treatment of patients with COVID-19. Veklury is currently available in the U.S. under an Emergency Use …

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