COVID-19 Update

Combatting Future Viral Threats with Vaccine Advances

The COVID-19 pandemic has led to many changes in how pharmaceutical companies develop vaccines.

What’s Next for COVID-19 Vaccines and Variants?

More technologies and treatments are emerging for COVID-19—along with new variants.

Key Elements for Assay Transfer Success

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers.

GreenLight Biosciences, Samsung Biologics Collaborate to Advance COVID-19 Vaccine Candidate

November 29, 2021

Samsung Biologics will manufacture GreenLight BioSciences' COVID-19 vaccine candidate for clinical trials and commercial sales.

US Government to Pay $1 Billion for GSK and Vir Biotechnology’s Early Treatment of COVID-19

November 23, 2021

United States government contracts total approximately $1 billion to purchase sotrovimab, an investigational mAb.

FDA Authorizes COVID-19 Boosters for All Adults

November 19, 2021

FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.

Celltrion Gains Nod from EC for Regdanvimab

November 19, 2021

EC has granted marketing authorization for Celltrion's Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19.

EMA Begins Evaluation of Novavax COVID-19 Vaccine Marketing Authorization Application

November 19, 2021

Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

Pfizer Submits COVID-19 Oral Antiviral Candidate to FDA for Emergency Use Authorization

November 17, 2021

Pfizer’s PAXLOVID oral solid-dosage treatment is designed to combat SARS-CoV-2 in high-risk patients at the first sign of infection.

EMA Recommends Two COVID-19 Treatments

November 11, 2021

The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.

EMA Starts Evaluation of Moderna’s COVID-19 Vaccine for Children

November 10, 2021

The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.

Birmingham Biotech and the University of Birmingham Sign Licensing Agreement for Antiviral Nasal Spray Against COVID-19

November 09, 2021

The agreement will allow Birmingham Biotech to commercialize the University of Birmingham’s antiviral COVID-19 nasal spray.

EMA Begins Review of COVID-19 Treatment

November 09, 2021

The agency is reviewing data on the use of molnupiravir (MK 4482 or Lagevrio) for potential use to treat COVID-19 prior to authorization.