Remove Immune Response Remove Marketing Remove Protein
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Celltrion’s Avtozma Receives FDA Approval, Making it the Third Actemra Biosimilar to Hit the Market

XTalks

The approval marks Celltrions seventh biosimilar to be granted marketing authorization in the US and its fifth immunology biologic approval. Avtozma is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist that works by targeting specific inflammatory proteins to dampen immune responses.

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How did pharma develop a vaccine so quickly?

World of DTC Marketing

Once introduced into the human body, the protein-making machinery uses this genetic material in our cells to churn out the coronavirus “spike protein,” triggering an immune response. It’s estimated that the COVID 19 vaccine market could be worth almost $100 billion. That’s a hell of an incentive.

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Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape

Pharmaceutical Technology

Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.

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COVID-19 vaccine development: Setback for Sanofi and GSK candidate, University of Queensland and CSL abandon trial

BioPharma Reporter

Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.

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mRNA Drugs: Pros, Cons, and Prospects

Pharma Mirror

The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021.

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Novavax receives positive opinion from CHMP for full MA of Covid vaccine

Pharmaceutical Technology

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU). The safety and efficacy of Nuvaxovid was evaluated as a primary series.

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Gritstone bio trumpets first data for ‘multivariant’ COVID jab

pharmaphorum

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “With new variants – like Omicron and B.1.640.2

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