Specialty Pharma Journal Specialty, Precision & Technology
Paris and Tarrytown, NY – November 6, 2018 – The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or …
Tag Archives: Regeneron
November, 2018
October, 2018
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1 October
FDA Approves Libtayo as First and Only Treatment for Advanced Cutaneous Squamous Cell Carcinoma
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint …
September, 2018
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13 September
FDA to Review Regeneron’s sBLA of Eylea Injection for the Treatment of Diabetic Retinopathy
TARRYTOWN, N.Y., Sept. 13, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA®(aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. The target action …
August, 2018
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17 August
FDA Approves Regeneron’s Eylea Injection sBLA in Wet Age-Related Macular Degeneration
TARRYTOWN, N.Y., Aug. 17, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year …
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16 August
Teva and Regeneron Announce Positive Results from Phase 3 Trial of Fasinumab in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip
JERUSALEM & TARRYTOWN, N.Y.–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. At the week 16 primary …
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6 August
Regeneron and bluebird bio Collaborate for Development of New Cell Therapies for Cancer
TARRYTOWN, N.Y. and CAMBRIDGE, Mass., Aug. 6, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and bluebird bio, Inc. (NASDAQ: BLUE) today announced a collaboration to apply their respective technology platforms to the discovery, development and commercialization of novel immune cell therapies for cancer. The collaborators will specifically leverage Regeneron’s VelociSuite® platform technologies for the discovery and characterization of fully human …
May, 2018
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1 May
FDA Grants Priority Review to Regeneron’s Cemiplimab for Treatment of Advanced Cutaneous Squamous Cell Carcinoma
TARRYTOWN, N.Y. and PARIS, April 30, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) …
December, 2017
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18 December
Regeneron and ISA Pharmaceuticals Enter Strategic Immuno-Oncology Collaboration
TARRYTOWN, N.Y. and LEIDEN, The Netherlands, Dec. 18, 2017 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, today announced a clinical collaboration to advance ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, in combination with cemiplimab (REGN2810), a PD-1 (programmed cell death protein 1) antibody. Regeneron and ISA …
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15 December
Regeneron and Sanofi Announce Positive Results for PD-1 Antibody Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma
TARRYTOWN, N.Y. and PARIS, Dec. 13, 2017 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive topline results from a pivotal Phase 2 clinical study of cemiplimab in 82 patients with advanced cutaneous squamous cell carcinoma (CSCC), the second deadliest skin cancer after melanoma. Cemiplimab, an investigational human antibody targeting PD-1 (programmed cell death protein 1), …
September, 2017
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8 September
Regeneron and Sanofi’s Cemiplimab Receives FDA Breakthrough Therapy Designation for Cutaneous Squamous Cell Carcinoma
TARRYTOWN, N.Y. and PARIS, Sept. 8, 2017 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer …