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FDA approves novel therapy for chronic skin condition
The US approval could improve outcomes for eligible patients with previously limited options for managing the inflammatory skin condition.
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Regeneron Pharmaceuticals
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Eosinophilic esophagitis medicine approval expanded
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.
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Regulatory-first for gene editing therapy
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.
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Sandoz to file for approval of aflibercept biosimilar
Sandoz intends to seek regulatory approval for its aflibercept biosimilar in the US and EU in the coming months.
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Could Dupixent be the first biologic to treat COPD?
Dupixent® is the first biologic to demonstrate significant improvement in lung function compared to placebo, a pivotal Phase III trial has shown.
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Top biopharma firms report Q3 market capitalisation decline
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.
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EC approves Libtayo® for metastatic cervical cancer
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.
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AEX-MS to become increasingly important in antibody characterisation
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.
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New mass spectrometry technique to detect low-level host cell proteins
Host cell protein-automated iterative mass spectrometry (HCP-AIMS) enables the robust, reproducible and high throughput analysis of host cell proteins, says study.
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REGEN-COV™ antibody cocktail reduces hospitalisation or death by 70 percent
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.
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EMA initiates rolling review of Regeneron’s COVID-19 mAb
The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
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EC approves Dupixent for children aged six to 11 to treat severe atopic dermatitis
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.
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FDA grants EUA to investigational antibody treatment for COVID-19
The Emergency Use Authorization (EUA) is based on a trial in which casirivimab and imdevimab reduced hospitalisations in mild to moderate COVID-19 patients.
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IDMC recommends modifications to Regeneron COVID-19 antibody trial
The clinical trial testing the REGN-COV2 antibody cocktail should be altered, according to the Independent Data Monitoring Committee (IDMC).
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Regeneron named top biopharma company to work for
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.
