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Approval of the first treatment for patients one year old and over with eosinophilic esophagitis (EoE) was based on trial data showing a greater proportion of children given Dupixent achieved histological remission compared to placebo.
The world’s first investigational in vivo CRISPR-based gene editing therapy cleared for late-stage clinical development is expected to enter Phase III in late 2023.
Sandoz intends to seek regulatory approval for its aflibercept biosimilar in the US and EU in the coming months.
Dupixent® is the first biologic to demonstrate significant improvement in lung function compared to placebo, a pivotal Phase III trial has shown.
The top 20 biopharma companies averaged a market capitalisation decline of $3.45 trillion in Q2 to $3.14 trillion in Q3 2022, says GlobalData.
The European Commission has approved Libtayo® for cervical cancer and disease progression while on or after platinum-based chemotherapy, due to positive Phase III trial results.
Study shows AEX-MS enables the analysis of IgG4 Fc deamidation variants and, as IgG4 antibodies become more popular, could become increasingly valuable for antibody charge heterogeneity characterisation.
Host cell protein-automated iterative mass spectrometry (HCP-AIMS) enables the robust, reproducible and high throughput analysis of host cell proteins, says study.
Phase III data shows treatment with REGEN-COV™ (casirivimab and imdevimab) significantly reduces the risk of high-risk COVID-19 infected outpatients being hospitalised or dying.
The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
The EC has approved an extension of marketing authorisation for Regeneron and Sanofi's Dupixent (dupilumab) for children aged six to 11 with severe atopic dermatitis.
The Emergency Use Authorization (EUA) is based on a trial in which casirivimab and imdevimab reduced hospitalisations in mild to moderate COVID-19 patients.
The clinical trial testing the REGN-COV2 antibody cocktail should be altered, according to the Independent Data Monitoring Committee (IDMC).
![Phone with regeneron logo on it in front of blurred laboratory background [Credit: adrianosiker.com/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Regeneron-300x278.jpg)
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According to Regeneron, it has placed either first or second in the same ranking for the past ten years, making it the most highly ranked company of the decade.
The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) for the treatment of Zaire ebolavirus infection in adults and children.
