Regeneron Pharmaceuticals, Inc.

1283 articles with Regeneron Pharmaceuticals, Inc.

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  Dupixent Clears Phase III in Bid to Become First Biologic for COPD

  3/23/2023

  Sanofi and Regeneron’s Dupixent (dupilumab) met its primary and all secondary endpoints in the Phase III BOREAS trial, significantly reducing severe exacerbations in COPD.

• Dupixent® (dupilumab) Demonstrates Potential to Become First Biologic to Treat COPD by Showing Significant Reduction in Exacerbations in Pivotal Trial

  3/23/2023

  Regeneron Pharmaceuticals, Inc. and Sanofi announced the primary and all key secondary endpoints were met in a Phase 3 trial evaluating the investigational use of Dupixent® compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease and evidence of type 2 inflammation.

• FDA Approves First-in-class Evkeeza® (evinacumab-dgnb) for Young Children with Ultra-rare Form of High Cholesterol

  3/22/2023

  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has extended the approval of Evkeeza® (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH).

• Dupixent® (dupilumab) Approved by European Commission as First and Only Targeted Medicine for Children as Young as Six Months Old with Severe Atopic Dermatitis

  3/21/2023

  Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission has approved Dupixent® in the European Union to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy.

• Press Release: Dupixent® (dupilumab) late-breaking data at AAD show significant improvements in signs and symptoms of moderate-to-severe atopic hand and foot dermatitis

  3/18/2023

  Positive results from the clinical trial assessing Dupixent® in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented.

• Dupixent® (dupilumab) Late-Breaking Data at AAD Show Significant Improvements in Signs and Symptoms of Moderate-to-severe Atopic Hand and Foot Dermatitis

  3/18/2023

  Regeneron Pharmaceuticals, Inc. and Sanofi presented positive results from the clinical trial assessing Dupixent® in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis.

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  The Top 12 Biopharma Companies Hiring Now

  3/7/2023

  In the past few weeks, the biopharma industry has been filled with layoffs and company launches. To learn about job opportunities at some of the industry's top companies, see inside.

• Dupixent® (dupilumab) Application for Treatment of Chronic Spontaneous Urticaria (CSU) in Adults and Adolescents Aged 12 Years and Older Accepted for FDA Review

  3/7/2023

  Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application for Dupixent® to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria that is not adequately controlled with the current standard of care, H1 antihistamine treatment.

• Kevzara® (sarilumab) Approved by FDA as First and Only Biologic Indicated for Patients with Polymyalgia Rheumatica

  2/28/2023

  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease, in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

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  FDA Action Alert: Cytokinetics, Reata, Regeneron, Pfizer and GSK

  2/27/2023

  The FDA is expected to cap off February with a trio of verdicts, including one for a heart failure treatment and another potential first approval for a rare, neurodegenerative disease.

• Libtayo® (cemiplimab) in Combination with Chemotherapy Receives Positive CHMP Opinion for the Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC)

  2/24/2023

  Regeneron Pharmaceuticals, Inc. announced the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo® in combination with platinum-based chemotherapy.

• Aflibercept 8 mg BLA for Treatment of Wet Age-Related Macular Degeneration and Diabetic Macular Edema Accepted for FDA Priority Review

  2/23/2023

  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8 mg for treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy.

• Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults with Ultra-rare CHAPLE Disease Accepted for FDA Priority Review

  2/21/2023

  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for pozelimab as a treatment for adults and children as young as 1 year of age with CHAPLE disease (also known as CD55 deficiency with Hyperactivation of complement, Angiopathic thrombosis and Protein Losing Enteropathy or CD55-deficient protein-losing enteropathy).

• EYLEA® (aflibercept) Injection Approved as the First Pharmacologic Treatment for Preterm Infants with Retinopathy of Prematurity (ROP) by the FDA

  2/8/2023

  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection to treat preterm infants with retinopathy of prematurity (ROP).

• Regeneron Reports Fourth Quarter and Full Year 2022 Financial and Operating Results

  2/3/2023

  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2022 and provided a business update.

• Regeneron Announces Investor Conference Presentations - Jan 31, 2023

  1/31/2023

  Regeneron Pharmaceuticals, Inc. will webcast management participation.

• 2seventy bio Announces Expanded Translational Collaboration with Regeneron to Develop New Cell Therapy-Based Combinations for Solid Tumors

  1/6/2023

  2seventy bio, Inc. (Nasdaq: TSVT) today announced an amendment to its collaboration with Regeneron that will facilitate an expanded and accelerated development plan for novel cell therapy-based combinations for solid tumors.

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  Reanalysis of Key Trial Flags Fresh Safety Concerns for Amgen’s Repatha (Updated)

  1/4/2023

  Amgen’s Repatha may cause cardiac harm, according to a reassessment of the biologic’s late-stage trial data.

• Regeneron to Report Fourth Quarter and Full Year 2022 Financial and Operating Results and Host Conference Call and Webcast on February 3, 2023

  1/3/2023

  Regeneron Pharmaceuticals, Inc. announced that it will report its fourth quarter and full year 2022 financial and operating results on Friday, February 3, 2023, before the U.S. financial markets open.

• Libtayo® (cemiplimab) Approved in Japan for Advanced or Recurrent Cervical Cancer

  12/23/2022

  Regeneron Pharmaceuticals (NASDAQ: REGN) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Libtayo ® (cemiplimab) as monotherapy to treat patients with advanced or recurrent cervical cancer whose disease progressed after chemotherapy.