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EpiVax and CUBRC Awarded FDA Contract Worth $2M for Development of Control Peptides for Immunogenicity Risk Assessment Assays Supporting Regulatory Filings of Generic Peptide Drugs

EpiVax and CUBRC Awarded FDA Contract Worth $2M for Development of Control Peptides for Immunogenicity Risk Assessment Assays Supporting Regulatory Filings of Generic Peptide Drugs

by Elena Iemma | Oct 24, 2024 | News

PROVIDENCE, R.I., Oct. 24, 2024 /PRNewswire/ — EpiVax, Inc. and CUBRC, Inc. announce today that they have been awarded a two-year, $2 million contract (#75F40124C00094) from the Office of Generic Drugs (OGD) of the Food and Drug...
EpiVax Secures Additional Funding from FDA for Immunogenicity Risk Assessment for Biosimilar Products

EpiVax Secures Additional Funding from FDA for Immunogenicity Risk Assessment for Biosimilar Products

by Elena Iemma | Sep 12, 2022 | News

PROVIDENCE, RI, September 12, 2022 /PRNewswire/ — EpiVax, Inc. (“EpiVax”) is pleased to announce the award of a two-year, $2 million grant from the FDA’s Office of Center for Drug Evaluation and Research (CDER) to validate a method for immunogenicity risk...
FDA Webinar: Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling

FDA Webinar: Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling

by Elena Iemma | Jan 26, 2021 | Events, Webinars

The FDA hosted a virtual workshop January 26, 2021 to provide updates and foster discussions around non-clinical assays for comparative immunogenicity risk assessment of generic peptide products. EpiVax CEO/CSO, Annie De Groot, presented an update on EpiVax’s...
EpiVax Secures Additional Funding from FDA for Immunogenicity Risk Assessment for Biosimilar Products

FDA Awards $1.1M Contract to CUBRC and EpiVax for Validation of New Immunoinformatic Tool for Prospective Immunogenicity Assessment of Peptide Drugs and Their Impurities

by Adam | Oct 22, 2020 | News

PROVIDENCE, RI, October 22, 2020 /PRNewswire/ — EpiVax, Inc. (“EpiVax”) and CUBRC, Inc. (“CUBRC”) announced today that they have been awarded a two-year, $1.1 million contract from the Office of Generic Drugs (OGD) in the Center of Drug Evaluation and Research...

Recent Posts

  • EpiVax Announces Laboratory Expansion and Streamlined, NAM-Centric In Vitro Services    
  • Replacing Animal Models with Human-Relevant New Approach Methodologies (NAMs) for Immunogenicity in Clinic
  • EpiVax Enters its Next Chapter with SV Health Investors
  • Immunogenicity Risk Assessment Outputs to Drive a Streamlined, Risk-Based Preclinical and Clinical Strategy
  • Immunogenicity Risk Assessment Outputs to Drive a Streamlined, Risk-Based Preclinical and Clinical Strategy

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