News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Pfizer and BioNTech have begun evaluating the safety and immunogenicity of a third dose of their mRNA vaccine, to understand the effect of a booster on immunity against current and emerging virus variants.
The FDA has outlined its analysis of Johnson & Johnson's single-shot COVID-19 vaccine, ahead of a meeting of the Vaccines and Related Biological Products Advisory Committee Meeting to assess the candidate's application for Emergency Use Authorization (EUA).
Moderna has announced new capital investments to increase COVID-19 vaccine manufacturing capacity: targeting global capacity of 1.4 billion doses in 2022.
Moderna’s variant-specific vaccine – designed to tackle the South Africa variant – has been shipped to the US National Institutes of Health (NIH) for a Phase 1 clinical trial.
Locus Biosciences says the results of its early stage clinical trial for CRISPR-enhanced bacteriophage therapy shows its precision medicine asset is safe and well tolerated.
A program at the University Hospital of Tübingen is the first in Germany to use whole genome sequencing (WGS) to improve the diagnosis of rare diseases and hereditary cancers.