BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

 BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Regeneron’s Eylea (aflibercept) Injection Receives the US FDA’s Approval as a Prefilled Syringe

Shots:

  • Regeneron will be responsible to deliver treatment doses for six years post-approval of product from the FDA, will receive compensation of ~$10M & average of $67M/year in 2021 and each for the next five years (2022-2026) respectively
  • In 2019, the PALM trial evaluated REGN-EB3 vs ZMapp conducted in the Democratic Republic of the Congo, was stopped as the REGN-EB3 crossed the pre-specified superiority threshold for preventing death in Ebola patients
  • Regeneron’s REGN-EB3 is a novel anti-viral Ab cocktail developed using its VelociSuite platform in collaboration and funding provided by BARDA. The product is under priority review by the US FDA with PDUFA date Oct 25, 2020

Click here to read full press release/ article | Ref: BusinessWire | Image: Behnace

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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