Emergent BioSolutions Inc. (NYSE: EBS) today announced the first participant dosed in its phase 1 study, EBS-UFV-001, evaluating the safety, tolerability, and immunogenicity of the company’s investigational universal influenza vaccine candidate. This current version of Emergent’s universal influenza vaccine candidate contains multiple components intended to induce broad and supra-seasonal immunity against influenza A viruses.
Quality assurance is a key function in the biopharma industry that provides a hands-on role in day-to-day operations. It’s a role that allows team members to maintain their fingers on the pulse of the beating heart of a drug manufacturing company. And it’s a role that’s available at one of the biggest drug manufacturing companies in the BioHealth Capital Region.
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Emergent BioSolutions’ COVID-19 Human Immune Globulin Product Candidate to be Evaluated in NIH-Sponsored Phase 3 Clinical Trial (INSIGHT-012) of Hyperimmune Intravenous Immunoglobulin for Outpatient Treatment of COVID-19
Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 3 clinical trial that will evaluate its investigational SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG) plasma-derived therapy as a potential outpatient treatment for patients with coronavirus disease (COVID-19) that are at high risk of progression to severe disease, including adults 55 and older and those 18 and older who are immunocompromised.
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) is allowing Emergent’s Bayview manufacturing facility to resume production of Johnson & Johnson’s (J&J) Covid-19 vaccine bulk drug substance. This resumption of manufacturing follows extensive reviews by FDA, weeks of diligent work, and close coordination with J&J and FDA to execute on Emergent’s quality enhancement plan.
The Storied 25 Year History Behind the Baltimore Biotech Manufacturing Facility Producing COVID-19 Vaccines
Emergent Biosolutions’ vaccine manufacturing plant in Baltimore has been the subject of many headlines this past year for its’ role in producing several COVID-19 Vaccines. However, the history of this facility goes back more than two decades.
COVID-19 Vaccine Drug Substance Manufactured by Emergent BioSolutions Authorized as Part of Johnson & Johnson’s Emergency Use Authorization
Emergent BioSolutions Inc. (NYSE:EBS) today announced that two batches of COVID-19 vaccine manufactured by Emergent BioSolutions at its Baltimore Bayview facility were determined to be suitable for use by the U.S. Food & Drug Administration (FDA) and have been authorized as part of Johnson & Johnson’s Emergency Use Authorization (EUA).
Emergent BioSolutions Announces Positive Two-Year Persistence Data From Phase 2 Study Evaluating CHIKV VLP, the Company’s Chikungunya Virus, Virus-Like Particle Vaccine Candidate
Emergent BioSolutions Inc. (NYSE:EBS) announced two-year persistence data from its Phase 2 clinical study evaluating the safety and immunogenicity of the company’s investigational chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate in 415 healthy adults.
Novavax trials highlight Maryland’s COVID-fighting complex When Novavax Inc. received $1.6 billion last year from the federal government to speed up testing and production of a coronavirus vaccine, some observers [….]