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Respiratory Syncytial

FDA Grants Fast Track Designation to Meissa Vaccines’ MV-012-968 Vaccine for Respiratory Syncytial Virus

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Meissa Vaccines (“Meissa”), a biotechnology company developing vaccines to prevent viral respiratory infections, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to MV-012-968, an investigational, live attenuated vaccine for protection against respiratory syncytial virus (RSV) infection. The FDA’s Fast Track …

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FDA Grants Breakthrough Therapy Designation to Janssen’s Investigational Prophylactic Vaccine for Prevention of Respiratory Syncytial Virus in Older Adults

LEIDEN, Netherlands, Sept. 3, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the Company’s investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RSV)-mediated lower respiratory tract disease in …

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Enanta’s EDP-938 Achieved its Primary and Secondary Endpoints in Phase 2a Human Challenge Study in Healthy Adults with Respiratory Syncytial Virus

WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced topline results that demonstrated that EDP-938 achieved highly statistically significant (p<0.001) reductions in viral load and in resolution of clinical symptoms compared to placebo …

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Novavax’s ResVax Fails Phase 3 Study for Prevention of RSV Disease in Infants via Maternal Immunization

GAITHERSBURG, Md., Feb. 28, 2019 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX) today announced results from Prepare™, a global Phase 3 clinical trial using ResVax, an aluminum adjuvanted respiratory syncytial virus (RSV) fusion (F) protein recombinant nanoparticle vaccine. ResVax is being developed to protect infants via maternal immunization against RSV …

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Experts Urge Action to Cut Child Deaths from Deadly Lung Virus

Vaccines to combat a virus that can lead to fatal lung infections are urgently needed to help prevent child deaths worldwide, research suggests. Experts report that more than 115,000 children under five are dying each year from complications associated with the infection, called Respiratory Syncytial Virus (RSV). Almost half of …

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Sanofi Pasteur and MedImmune Partner to Develop and Commercialize Respiratory Syncytial Virus Candidate

MedImmune, the global biologics research and development arm of AstraZeneca, and Sanofi Pasteur, the vaccines division of Sanofi, today announced an agreement to develop and commercialise MEDI8897 jointly. MEDI8897 is a monoclonal antibody (mAb) for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV), the …

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MedImmune’s Respiratory Syncytial Virus Candidate Receives Fast Track Status from the FDA

Today, AstraZeneca’s biologics arm MedImmune announced that US health regulators have granted fast track designation for its respiratory syncytial virus (RSV) candidate. The company said that the US Food and Drug Administration (FDA) has granted Fast Track status for the development of MEDI8897, a high-potency, extended half-life monoclonal antibody (mAb). …

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