Infectious Diseases

FDA Grants Emergency Use Authorization to Roche’s Elecsys IL-6 Test to Identify Patients at High Risk of Severe Inflammatory Response

Basel, 04 June 2020  – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Elecsys® IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify …

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Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. This open-label study evaluated 5-day and 10-day courses of the investigational antiviral remdesivir plus standard of care, versus standard of care alone. The study demonstrated …

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FDA Accepts Shionogi’s sNDA with Priority Review for Fetroja for Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020. …

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Siemens Healthineers Receives FDA Emergency Use Authorization for its SARS-CoV-2 Total Antibody Test that Delivers Superior Clinical Performance

TARRYTOWN, N.Y.–(BUSINESS WIRE)–Siemens Healthineers announced today the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies including IgM and IgG in blood. Test data demonstrated 100 percent sensitivity2 and 99.8 percent specificity. The total antibody …

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I-Mab Reports Interim Results from Part 1 Study for Anti-GM-CSF Antibody TJM2 to Treat COVID-19 Patients with Cytokine Release Syndrome

SHANGHAI and GAITHERSBURG, MD, May 27, 2020 /PRNewswire/ — I-Mab (NASDAQ: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced interim results from a multi-center, double blinded, randomized, placebo-controlled, three-arm clinical study (NCT04341116) of TJM2 in patients with cytokine release syndrome (CRS) …

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FDA Approves Amivas’ Artesunate for Injection for Treatment of Patients with Severe Malaria

FREDERICK, Md., May 27, 2020 /PRNewswire/ — Artesunate for Injection 110 mg, powder and solvent for solution is approved by FDA for initial treatment of severe malaria in adult and pediatric patients. Artesunate for Injection is in a group of drugs known as “artemisinin derivatives” and is on the World …

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Health System in Pandemic Epicenter Identifies Outcomes and New Risk Factors of Patients Hospitalized with COVID-19

NEW YORK, May 26, 2020 /PRNewswire/ — A team of investigators at NYU Langone Health determined that just over half of 5,279 patients who tested positive for COVID-19 were hospitalized — and nearly a quarter of those hospitalized died or were discharged to hospice, including 60 percent who required ventilators. …

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AstraZeneca Advances Response to Global COVID-19 Challenge as it Receives First Commitments for Oxford’s Potential New Vaccine

AstraZeneca is advancing its ongoing response to address the unprecedented challenges of COVID-19, collaborating with a number of countries and multilateral organisations to make the University of Oxford’s vaccine widely accessible around the world in an equitable manner. The Company has concluded the first agreements for at least 400 million …

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Infectious Disease Connect and ILÚM Health Solutions Combine to Advance Precision Treatment of Infectious Diseases and Antimicrobial Stewardship

KENILWORTH, N.J. & PITTSBURGH–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, and UPMC today announced that Infectious Disease Connect Inc., a UPMC-backed company offering telemedicine-enabled solutions to hospitals for treatment of infectious diseases, has combined with Merck’s ILÚM Health Solutions, a provider of technology and services to support infectious disease …

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Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by …

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