Regeneron Pharmaceuticals
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1988-01-01
- Employees
- 13.4K
- Market Cap
- $132.4B
- Website
- http://www.regeneron.com
- Introduction
Regeneron Pharmaceuticals, Inc. is a biotechnology company, which engages in the discovery, invention, development, manufacture, and commercialization of medicines. Its product portfolio includes the following brands: Dupixent, Evkeeza, Eylea, Inmazeb, and Kevzara. The firm accelerates the traditional drug development process through its proprietary VelociSuite technologies such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies. The company was founded by Alferd G. Gilman, Leonard S. Schleifer, George Damis Yancopoulos, and Eric M. Shooter on January 8, 1988, and is headquartered in Tarrytown, NY.
EMA issues positive view on Samsung Bioepis' Eylea biosimilar
Samsung Bioepis received a positive scientific opinion from the EMA’s CHMP for Opuviz (SB15), a biosimilar referencing Eylea, after reviewing its MAA. A positive CHMP opinion typically leads to EC approval within 2-3 months. Opuviz targets ophthalmic diseases like wet AMD, inhibiting VEGF to prevent new blood vessel formation. Biogen, Samsung Bioepis’ partner, will manage European marketing and distribution post-approval.
EMA committee recommends approval of Sanofi & Regeneron's Dupixent to treat ...
EMA's CHMP recommends Dupixent for EoE in children aged 1-11 years, supported by phase 3 EoE KIDS study showing histological remission and symptom improvement. Safety consistent with known profile. Pending EU approval.
AERIFY-1/2: two phase 3, randomised, controlled trials evaluating itepekimab in former smokers with moderate-to-severe COPD
AERIFY-1 and AERIFY-2 are phase 3 trials evaluating itepekimab, an anti-IL-33 monoclonal antibody, in former smokers with moderate-to-severe COPD. These studies aim to confirm itepekimab's efficacy in reducing exacerbations and improving lung function, as observed in a phase 2 study, with a focus on safety and symptomatic benefits over 52 weeks.
Related Clinical Trials:
Regeneron/Sanofi Dupixent endorsed in EU for eosinophilic esophagitis for children
The article discusses the implementation of a Server-Side Rendering (SSR) service entry point, identified by the file path '/bundles/v1/views/latest/SSR-service-entry.a43029b098f75e2757ed.js'.
Neoadjuvant Dato-DXd, Durvalumab Response Rates Vary in Breast Cancer
Dato-DXd plus durvalumab achieved a 50% pathologic complete response (pCR) rate in stage II/III high-risk HER2-negative breast cancer patients, according to the I-SPY 2.2 trial. The study emphasizes evaluating treatment response per response predictive subtype (RPS) and suggests further investigation in immune-positive and hormone receptor (HR)-negative/DNA damage repair deficiency (DRD)-negative subtypes. The combination's efficacy was supported by the BEGONIA trial, showing a 79% objective response rate in metastatic triple-negative breast cancer. The I-SPY 2.2 trial design uses RPS to optimize drug assignment, aiming to improve efficacy and minimize toxicity.
Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ
Samsung Bioepis and Biogen's OPUVIZ™, a biosimilar referencing Eylea (aflibercept), recommended for marketing authorization by the European Medicines Agency for treating neovascular AMD, macular oedema secondary to RVO, DME, and myopic CNV.
Dupixent recommended for pediatric EoE in EU
The CHMP recommends Dupixent for EoE in children aged 1+ in the EU, pending EC approval. Dupixent, co-developed by Regeneron and Sanofi, showed significant histological remission in EoE KIDS Phase 3 trial. Regeneron's financial performance is strong, with Dupixent revenues surging 29% to $3.56 billion. Dupixent also received expanded FDA approval for chronic rhinosinusitis with nasal polyps in adolescents.
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children aged 1-11 years
CHMP recommends EU approval of Dupixent for eosinophilic esophagitis in children aged 1-11 years, based on phase 3 study showing histological remission. If approved, it would be the first treatment for this age group in the EU.
Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Eosinophilic ...
CHMP recommends Dupixent for EoE in children aged 1-11, based on Phase 3 trial showing histological remission. If approved, it would be the first EU treatment for this age group.
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