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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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Malaysia approves additional indication for Astrazeneca’s Evusheld

Pharmaceutical Technology

It will also be used for the treatment of people who are not likely to have an adequate immune response to Covid-19 vaccination or for people who are not recommended for Covid-19 vaccination. Dr Noor Hisham was quoted as saying: “The use of Evusheld was based on clinical guidelines issued by the health ministry.”

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GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

They intend to develop vaccines that provide lasting immune responses compared to existing vaccines. In March, the company entered a licensing agreement with Serum Institute of India (SII) to expedite access to messenger RNA products in emerging markets worldwide.

Vaccine 245
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Astellas and Sutro partner to develop immunostimulatory ADCs

Pharmaceutical Technology

Sutro holds an option to share in the costs and profits to develop and market product candidates in the US. On Sutro exercising its option for a specific product candidate, the companies will equally split the expenses of the joint development and marketing, and the resulting profits/losses from co-marketing will be split equally in the US.

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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.

Vaccine 277
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Vaxcyte trains its sight on a lucrative market with pneumococcal vaccine

Pharmaceutical Technology

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. What’s more, VAX-24 achieved a higher immune response to 16 of the 20 serotypes it shares with Prevnar 20.

Vaccine 162
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Meningitis vaccine comes to the forefront with impressive study results

Pharmaceutical Technology

The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. The response was more powerful than that generated by MenACWY-D – a licensed quadrivalent meningococcal vaccine marketed by GSK. for serogroup W to 20.5

Vaccine 195