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Regeneron Pharmaceuticals

The marketing authorisation application (MAA) for cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma (CSCC) has been accepted for review by the European Medicines Agency (EMA). more

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The European Medicines Agency (EMA) has accepted for review an application for an add-on maintenance treatment in certain adults and adolescents (12 years and older) with inadequately controlled moderate-to-severe asthma, Dupixent (dupilumab). more

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Plans have been announced by Sanofi and Regeneron to make Praluent (alirocumab) more accessible and affordable for those patients with the greatest health risk and unmet need. more

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The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application (sBLA) of Dupixent (dupilumab) for review, revealed joint developers of the drug, Regeneron and Sanofi. more

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Sanofi and Regeneron have revealed that they will accelerate and expand investment for the clinical development programmes of cemiplimab in oncology and dupilumab in type 2 allergic diseases. more

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Sanofi and Regeneron Pharmaceuticals have revealed positive results from a Phase II investigational study of dupilumab, for the treatment of adults with moderate-to-severe eosinophilic oesophagitis. more

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The European Commission (EC) has granted marketing authorisation to Sanofi and Regeneron Pharmaceuticals for dupilumab (Dupixent) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. more

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Sanofi and Regeneron Pharmaceuticals have revealed that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation status to cemiplimab (REGN2810), an investigational human, monoclonal antibody. more

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Regeneron Pharmaceuticals has announced plans to discontinue further clinical development of its antibody, suptavumab, for respiratory syncytial virus, as it has not met the primary endpoint of preventing infections in infants in the Phase III study more

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Sanofi and Regeneron Pharmaceuticals have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for marketing authorization of Dupixent (dupilumab). more

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Sanofi and Regeneron Pharmaceuticals have announced that the European Commission (EC) has granted marketing authorisation of Kevzara in combination with methotrexate for the treatment of moderately to severely active rheumatoid arthritis in adults more

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Sanofi and Regeneron Pharmaceuticals have announced positive results from two Phase IIIb/IV ODYSSEY-DM trials evaluating Praluent (alirocumab) in patients with diabetes and hypercholesterolemia. more

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Sanofi and Regeneron Pharmaceuticals have announced the FDA’s approval of Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) more

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Sanofi and Regeneron Pharmaceuticals has announced that the FDA has accepted the resubmission of the biologics licence application for Kevzara (sarilumab) as a Class I response with a two-month review timeline. more

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Sanofi and Regeneron have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation of Kevzara (sarilumab). more

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Sanofi and Regeneron Pharmaceuticals have announced that the US FDA has approved Dupixent (dupilumab) injection, which is the first targeted biologic therapy for adults suffering from moderate-to-severe atopic dermatitis. more

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EPM looks at company relationships in the pharma sector to see which companies are teaming up for new developments and which companies are ‘taking a break’ more

Opinion

Bayer and Regeneron Pharmaceuticals collaborate on a combination therapy to treat eye diseases more

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A US district court jury have ruled that the asserted claims of two Amgen patents for antibodies targeting PCSK9 are valid, yet Sanofi and Regeneron Pharmaceuticals have announced that they disagree with the verdict more

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The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Sanofi and Regeneron Pharmaceuticals’ sarilumab more

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