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Chief District Judge Thomas Kleeh denied Regeneron Pharmaceuticals, Inc.‘s REGN effort to prevent the sale of Amgen Inc‘s AMGN Eylea biosimilar.
Investors looking for stocks in the Medical - Biomedical and Genetics sector might want to consider either Harmony Biosciences Holdings, Inc. (HRMY) or Regeneron (REGN). But which of these two stocks presents investors with the better value opportunity right now?
REGN and SNY get positive CHMP opinion on the label expansion of Dupixent in the EU for eosinophilic esophagitis in children down to 1 year of age.
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescents If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group Paris and Tarrytown, NY, September 20, 2024. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of Dupixent (dupilumab) in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age.
Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved histological remission compared to placebo, consistent with improvements seen in adults and adolescents
BMO Capital Markets managing director of biopharma equity research Evan Seigerman joins Market Domination to discuss the best biotech plays outside of the GLP-1 weight-loss space. The sky-high demand for GLP-1 weight-loss drugs has led the biotech sector to reach new heights over the last year, and Seigerman believes the trend is as "hot as ever.
Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions TARRYTOWN, N.Y. and PARIS, Sept.
This is the second pivotal late-stage study on SNY/REGN's Dupixent in chronic spontaneous urticaria indication to meet primary and key secondary endpoints.
Three new post-hoc analyses highlight EYLEA HD rapid and sustained fluid control and consistent safety profile over two years in patients with wet age-related macular degeneration (wAMD)
Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU Confirming the results of CUPID-A, this second pivotal study in biologic-naïve patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores compared to placebo More than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is inadequately controlled by antihistamines Data will support regulatory resubmission in the US by year-end; if approved, Dupixent would be the first targeted therapy for CSU in a decade Paris and Tarrytown, NY, September 11, 2024. A Dupixent (dupilumab) confirmatory phase 3 study (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologic-naïve CSU receiving background therapy with antihistamines.