Remove 2004 Remove Pharmacokinetics Remove Virus
article thumbnail

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

The Pharma Data

Ronapreve is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work.

article thumbnail

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Pharma Data

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

GSK and Vir Biotechnology announce the start of the EMA rolling review of VIR-7831 (sotrovimab) for the early treatment of COVID-19

The Pharma Data

Separately, the CHMP is also reviewing sotrovimab under Article 5(3) of Regulation 726/2004 and is expected to provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorisation. About the Vir and GSK Collaboration.

article thumbnail

Making a “Miracle” HIV Medicine

Codon

million by 2004. Experimenting with a retrovirus called murine leukemia virus , he found that zidovudine did, in fact, obstruct retrovirus replication by inhibiting reverse transcriptase. Healthcare workers who became exposed to the virus while treating patients in the 1980s took zidovudine as a prophylactic. Always free.