Tag: COVID-19

November 23, 2020

Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported […]

November 18, 2020

The Food and Drug Administration has asked a group of advisors to set aside three days in early December for potential meetings to discuss Covid-19 vaccines — a key step in the agency’s authorization process, according to two people familiar […]

November 16, 2020

Moderna said today that its COVID-19 vaccine candidate mRNA-1273 passed its most important test, the 30,000+ patient Phase III COVE trial (NCT04470427), by showing itself to be 94.5% effective in preventing COVID-19—an outcome hailed by CEO Stéphane Bancel as a […]

November 11, 2020

Bamlanivimab is now available under emergency use for the treatment of mild to moderate COVID-19 in adults and paediatric patients 12 years and older who are at high risk of progressing to severe COVID-19 and/or hospitalisation. In a statement, Lilly […]

November 10, 2020

Several states have pledged to review COVID-19 vaccines themselves, after U.S. Food and Drug Administration (FDA) Emergency Use Authorizations EUA), to ensure safety and efficacy. A robust review, however, is unlikely. In reality, if state reviews go forward, they most […]

November 6, 2020

The Food and Drug Administration announced on Friday that it has authorized the first serology test that screens for neutralizing antibodies caused by a previous coronavirus infection. Neutralizing antibodies prevent viruses from infecting cells, though questions remain about how long […]

November 4, 2020

While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. Food and Drug Administration (FDA) has remained busy lining up potential approvals of medications for other diseases and illnesses. Many of these […]

November 3, 2020

There are currently hundreds of COVID-19 vaccine candidates in development around the world. Some of the challenges facing them are the requirement of large doses, complex manufacturing, and cold-chain shipping and storage. An ultrapotent vaccine that is safe, effective at […]

October 28, 2020

Today, 54gene announced the launch of its Clinical Program Services (CPS) division. The CPS division is focused on partnering with global pharmaceutical and biotechnology companies, and multilateral health organizations to discover, develop, and commercialize new therapeutic and diagnostic products. 54gene, […]

October 27, 2020

Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced updates on its Phase 3 clinical development program of NVX-CoV2373, its COVID-19 vaccine candidate. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle […]

October 20, 2020

The biotech behind AstraZeneca and the University of Oxford’s late-stage pandemic vaccine has hired Margaret (Meg) Marshall, M.D., as its new chief medical officer. Marshall joined as a consultant to Oxford spinout Vaccitech in the summer, but she now jumps […]

October 7, 2020

On October 6, the U.S. Food and Drug Administration issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent […]