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

Published on :

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 :

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 :

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 :

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 :

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 :

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. 

Novavax and Serum Institute of India File for Emergency Use Authorization of Novavax’ COVID-19 Vaccine in South Africa

Novavax logo
Published on :

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, today announced a regulatory submission to the South African Health Products Regulatory Agency (SAHPRA) for emergency use authorization (EUA) of Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. If authorized, the vaccine (known as NVX-CoV2373) will be manufactured by and commercialized by SII in South Africa under the brand name Covovax™.

Novavax Receives Positive European Medicines Agency Recommendation for Conditional Marketing Authorization of its COVID-19 Vaccine

Novavax logo
Published on :

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for Novavax’ COVID-19 vaccine (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age and older.

Emergent BioSolutions Secures Multi-Year Development and Manufacturing Agreement with Providence Therapeutics for its mRNA COVID-19 Vaccine Candidate, PTX-COVID19-B

Published on :

Total baseline value for Emergent is approximately $90 million USD, further expanding the collaboration between the companies, which began in February 2021