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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. That was followed by a full approval for the same patient subset in December 2022, making it the first FDA-approved monoclonal antibody to treat COVID-19.

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IXCHIQ Chikungunya Vaccine Trial Shows Sustained Immune Response in Adolescents

XTalks

seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. The study included 754 adolescents, comparing immune responses and safety profiles between vaccine and placebo groups. The findings reveal a remarkable 98.3%

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Astellas and Sutro partner to develop immunostimulatory ADCs

Pharmaceutical Technology

Astellas Pharma and Sutro Biopharma have entered a global, strategic partnership and licencing agreement to discover and develop new immunostimulatory antibody-drug conjugates (iADCs). An iADC merges an antibody with a small molecule compound that elicits immunogenic cell death, and an immune-activating molecule.

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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. Evusheld (formerly AZD7442) is a combination of two long-acting antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061).

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Regeneron’s antibody cocktail active against coronavirus, cuts symptoms

pharmaphorum

Regeneron’s antibody cocktail seems to reduce levels of coronavirus and improve symptoms in patients, according to early test results. This first data comes from a descriptive analysis from the seamless phase 1/2/3 trial that Regeneron hopes will hurry the medicine dubbed REGN-COV2 to market.

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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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AZ’s antibody first to be cleared by FDA for COVID prevention

pharmaphorum

AstraZeneca’s antibody cocktail for COVID-19, now called Evushield, has become the first drug in the class to be authorised for prevention of infection by the US FDA. The emergency use authorisation (EUA) for Evushield activates a 700,000 order for the antibody from the US government, worth upwards of $726 million.

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