Infectious Diseases

Sanofi and Translate Bio Expand Collaboration to Develop mRNA Vaccines Across All Infectious Disease Areas

PARIS and LEXINGTON, MASS. – June 23, 2020 – Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, have agreed to expand their existing 2018 collaboration and license agreement to develop mRNA vaccines for infectious diseases. The expansion of …

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Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine Met Safety and Immunogenicity Objectives in Initial Phase 3 Studies

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from two initial Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. Results from the PNEU-WAY (V114-018) study in adults 18 years of age …

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Microsoft and Adaptive Launch ImmuneCODE Database to Share Populationwide Immune Response to COVID-19

SEATTLE and REDMOND, Wash., June 11, 2020 /PRNewswire/ — Adaptive Biotechnologies Corp. (Nasdaq: ADPT) on Thursday launched ImmuneCODE with Microsoft Corp. (Nasdaq: MSFT) to begin sharing one of the largest, most detailed views of the immune response to COVID-19 in real time based on de-identified data generated from thousands of …

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Moderna Advances Late-Stage Development of its Vaccine (mRNA-1273) Against COVID-19

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 progress on late-stage development of mRNA-1273, the Company’s mRNA vaccine candidate against COVID-19. Moderna has finalized the Phase 3 study …

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Illumina Receives First FDA Emergency Use Authorization for a Sequencing-Based COVID-19 Diagnostic Test

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) is paving the way for large-scale, next-generation sequencing-based (NGS) COVID-19 testing. Today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Illumina COVIDSeq™ Test, a high-throughput, sequencing-based, in vitro diagnostic (IVD) workflow enabling the detection of SARS-CoV-2. The …

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FDA Approves Merck’s Recarbrio for Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

ENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age and older with …

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AbbVie, Harbour BioMed, Utrecht University and Erasmus Medical Center Collaborate to Develop Monoclonal Antibody Therapy to Prevent and Treat COVID-19

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill. & UTRECHT & ROTTERDAM, The Netherlands & SUZHOU, China–(BUSINESS WIRE)–AbbVie (NYSE:ABBV), Harbour BioMed (HBM), Utrecht University (UU) and Erasmus Medical Center (EMC) today announced they have entered into a collaboration to develop a novel antibody therapeutic to prevent and treat COVID-19, the pandemic respiratory …

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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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