Remove Definition Remove Immune Response Remove Licensing Remove Vaccine
article thumbnail

FIRST AUTHORIZATION IN EUROPEAN UNION FOR COVID-19 VACCINE IN ADOLESCENTS

The Pharma Data

This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. g doses of the COVID-19 vaccine.

Vaccine 52
article thumbnail

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

The Pharma Data

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. billion doses by the end of 2021.

Vaccine 52
Insiders

Sign Up for our Newsletter

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

article thumbnail

Where's the Synthetic Blood?

Codon

While blood doesn’t fit neatly into the various definitions of an organ , it still comprises a discrete system with specific functions. It is licensed in Russia and South Africa and is included in a few compassionate use programs across the globe, meaning it can be used clinically in cases where patients have few remaining options.

article thumbnail

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

Vaccine 52
article thumbnail

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

The Pharma Data

Vaccines up 14.6%, driven by record demand for differentiated influenza vaccines and continued growth of PPH. to €36,041 million, driven by Dupixent ® (€3,534 million, up 73,9%) and Vaccines. We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks.

Vaccine 52
article thumbnail

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Vaccines delivered growth in its core segments. Business net income is a non-GAAP financial measure (definition in Appendix 7). Influenza vaccines (incl.

Vaccine 52
article thumbnail

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Definition of High-Risk Patients.