News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Human B cells continue to work against SARS-CoV-2 months after infection, but derived antibodies do not recognize mutant variants from Brazil and South Africa, finds new research published in Science Immunology.
Clover Biopharmaceuticals today announced that it has raised US$230m in Series C financing, bringing to over US$400m the funds it has generated in the past 12 months.
The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.
Sanofi and GSK have initiated a new Phase 2 study for their COVID-19 vaccine candidate; with a Phase 3 study set to follow in Q2 and potential rollout of the vaccine in Q4.
Sanofi’s vaccine manufacturing plant in Marcy l’Etoile, France, will formulate and fill vials of Janssen’s COVID-19 vaccine: producing around 12 million doses a month to help address global supply demands.
Real-world data from England shows that the Pfizer/BioNTech vaccine offers 'clear protection from first dose' and may help interrupt transmission; while Scottish data shows the first doses of vaccines led to a substantial fall in hospital admissions.