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Regeneron Pharmaceuticals, Inc.

http://www.regeneron.com

Latest From Regeneron Pharmaceuticals, Inc.

Amgen/AstraZeneca’s Tezepelumab Cuts Asthma Exacerbations By 56%

Data presented at AAAI meeting show reduced annualized asthma exacerbation rates across all patient populations, but doctors are unlikely to switch patients served well by existing biologics. 

Respiratory Clinical Trials

First Oral Treatment For Spinal Muscular Atrophy Gets EMA Nod

New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.

Approvals Coronavirus COVID-19

US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols

Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.

Drug Review Profile Approvals

Inmazeb Brought Regeneron A Priority Review Voucher, But Not The Type It Wanted

Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.

Drug Review Profile Approvals
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Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Drug Discovery Tools
    • Gene Therapy, Cell Therapy
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Regeneron Genetics Center LLC (RGC)
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