Ellume’s COVID-19 Home Test Automatically Reports Depersonalized Test Results to HHS and State Health Departments to Better Track Virus Spread 

Published on : Published by : BioBuzz Media

With the rise of at-home testing and a recent increase of COVID-19 cases across the United States, public health officials have expressed concern about an undercounting of cases and a lack of data that may hamper America’s pandemic response. Digital diagnostics company Ellume is today highlighting its COVID-19 Home Test’s automatic reporting function that enables test results to be securely shared with the Department of Health and Human Services (HHS) and State Health Departments – allowing for real-time insights into pandemic trends. The resulting data is deidentified and encrypted to protect consumer identity and privacy. 

Initial Results from Novavax’ COVID-19-Influenza Vaccine Trial are First to Show Feasibility of Combination Vaccine

Novavax logo
Published on : Published by : BioBuzz Media

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial results from the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax’ COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated and immunogenic.

Ellume Celebrates Grand Opening of First American Facility in Frederick, MD

Photo of Ellume's facility in Frederick, MD
Published on : Published by : Erika Riley

Governor Larry Hogan joined dozens of attendees at Ellume’s grand opening in Frederick on March 31 to welcome the diagnostics manufacturer to Frederick County. Ellume’s 215,000-square-foot production facility on Executive Way has been up and running since February 2022, only ten months after the company signed a lease with Matan Properties. 

Novavax and Serum Institute of India Announce First Emergency Use Authorization of Novavax’ COVID-19 Vaccine in Adolescents ≥12 to <18 in India

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Published on : Published by : BioBuzz Media

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax’ protein-based COVID-19 vaccine for adolescents aged ≥12 to <18 years in India. The vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by SII under the brand name Covovax™ and is the first protein-based vaccine authorized for use in this age group in India.

NRx Aims to Bring Zyesami to Market Based on Real-World Data in Treating Seriously Ill COVID-19 Patients

Published on : Published by : Alex Keown

For Jonathan Javitt, Chief Executive Officer of NRx Pharmaceuticals, the company’s experimental COVID-19 treatment aviptadil, which will be known by the trade named Zyesami, can play a key role in saving the lives of those patients who are seriously ill and have failed to respond to Gilead Sciences’ antiviral drug, Remdesivir.

MaximBio Wins EUA for At-Home COVID-19 Test

Image of COVID-19 antigen test box
Published on : Published by : Alex Keown

At the end of January, the U.S. Food and Drug Administration granted Emergency Use Authorization to MaximBio’s ClearDetect COVID-19 Antigen Home Test, which has been designed to be as user-friendly as possible. MaximBio Chief Operating Officer Jonathan Maa believes that the company’s ClearDetect test will differentiate itself from other tests on the market due to its simplicity and the strength of the company’s proven Lateral Flow Assay (LFA) technology. In an interview with BioBuzz, Maa said at-home testing is an urgent need in the United States and that need “will exist for some time.”

Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine

Novavax logo
Published on : Published by : BioBuzz Media

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.

MaximBio and Thomas Scientific Ink Marketing Agreement for ClearDetectTM COVID-19 Antigen Home Test

Image of COVID-19 antigen test box
Published on : Published by : BioBuzz Media

Today, Maxim Biomedical (MaximBio), a leading diagnostic healthcare company and manufacturer of trusted diagnostic solutions announced a comprehensive Marketing and Distribution Agreement with Thomas Scientific for the ClearDetectTM COVID-19 Antigen Home Test (ClearDetectTM) which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration on January 19, 2022.  

Maxim Biomedical Inc. Receives EUA for New ClearDetect™ COVID-19 Antigen Home Test

Image of COVID-19 antigen test box
Published on : Published by : BioBuzz Media

Maxim Biomedical (MaximBio) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for their new ClearDetect™ COVID-19 Antigen Home Test (ClearDetect™). The at-home diagnostics market is growing rapidly and is expected to value over USD 7.6 billion and register a CAGR of over 5.4% by the end of 2028.  MaximBio designed, tested, and will manufacture their new assay in the United States to help meet this growing demand for home testing.

Moving Toward Workforce Optimism in 2022

Published on : Published by : Deepa Kumar

The last two years (and, unfortunately, counting…) have been brutal on all of us emotionally. And, among the various ups and downs, we’re gradually realizing that this pandemic may never fully go away. It’s all very taxing on our mental, physical, and emotional currency. We’re weighted by a blanket of pessimism because we’ve been conditioned to believe in the light at the end of the tunnel. In this instance, though, every time we think we’re getting closer to the light the tunnel just seems to get longer.