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Tag: COVID-19


Industry, Vaccines

AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19

November 23, 2020

Via: World Pharma News

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 […]


FDA, Regulations

FDA said to plan early December advisory meetings to discuss Covid-19 vaccines ahead of potential authorization

November 18, 2020

Via: CNBC

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 […]


Industry, Vaccines

Moderna COVID-19 Vaccine 94.5% Effective in Early Phase III Data

November 16, 2020

Via: Genetic Engineering and Biotechnology News

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 […]


FDA, Regulations

FDA grants emergency authorisation to Lilly’s COVID-19 antibody

November 11, 2020

Via: Pharma Times

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 […]


Industry, Vaccines

BIO Chairman: FDA Vaccine Reviews Too Complex and Costly for States to Replicate

November 10, 2020

Via: BioSpace

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 […]


Clinical Trials, FDA, Regulations, Research and Development

FDA authorizes first test that screens for Covid-neutralizing antibodies

November 6, 2020

Via: CNBC

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 […]


FDA, Regulations

FDA Awards Fast Track Designation to Multiple Non-COVID-19 Candidates

November 4, 2020

Via: BioSpace

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 […]


Industry, Vaccines

COVID-19 Nanoparticle Vaccine Elicits High Levels of Protective Antibodies in Mice

November 3, 2020

Via: Genetic Engineering and Biotechnology News

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 […]


Clinical Trials, Research and Development

Clinical Research Program and COVID-19 Collaboration Launched in Nigeria

October 28, 2020

Via: Genetic Engineering and Biotechnology News

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, […]


Clinical Trials, Research and Development

Novavax provides Phase 3 COVID-19 vaccine clinical development update

October 27, 2020

Via: World Pharma News

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 […]


Industry, Vaccines

COVID-19 vaccine biotech Vaccitech nabs Pfizer, Kite vet as full-time CMO

October 20, 2020

Via: FierceBiotech

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 […]


FDA, Industry, Regulations, Vaccines

FDA Issues Guidance on EUA for COVID-19 Vaccines

October 7, 2020

Via: Contract Pharma

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 […]