All Regeneron Pharmaceuticals articles
-
ArticleStrengthening regulatory consistency - why predictability matters rather more than speed
Regulatory predictability has become an increasingly important factor in determining where clinical development takes place. Drawing on lessons learned from delivering complex programmes across Europe, Regeneron’s Dr Muriel O’Byrne explores how greater consistency can help sponsors maximise value.
-
NewsFAP-targeted radiopharmaceuticals potential as next-gen treatment for multiple cancers
Innovative radiopharmaceuticals demonstrated “highly promising” survival benefit in study of participants with end-stage solid tumours.
-
NewsOtarmeni Regeneron’s first genetic medicine to gain approval
Authorisation of the AAV gene therapy in the US marks a milestone for treating genetic hearing loss.
-
NewsRegeneron and Telix collaborate to advance biologics-based radiopharmaceuticals
Potential $4.3 billion partnership deal to develop next-generation radiopharmaceutical therapies for hard-to-treat cancers.
-
NewsFDA 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.
-
NewsEosinophilic 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.
-
NewsRegulatory-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.
-
NewsSandoz 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.
-
NewsCould 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.