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...
Results for "fda contract"
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
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 (CDER)...
EpiVax and FDA Scientists Publish New Insights on Immunogenicity Risks of Peptide-Related Impurities in Generic Teriparatide
EpiVax and FDA Scientists Publish New Insights on Immunogenicity Risks of Peptide-Related Impurities in Generic Teriparatide PROVIDENCE, R.I., Dec. 8, 2025 — EpiVax, Inc., with U.S. Food and Drug Administration (FDA) and CUBRC, Inc. (Buffalo, NY) scientist...
EpiVax Secures Additional Funding from FDA for Immunogenicity Risk Assessment for Biosimilar Products
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 assessment...
FDA Webinar: Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling
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 PANDA...
Breaking News: FDA awards $1 million to EpiVax, CUBRC, to assess generic peptide drugs
This original article was published on October 2nd, 2018 in ConvergenceRI. PROVIDENCE, RI – The U.S. Food and Drug Administration announced on Tuesday, Oct. 2, that the federal agency has awarded EpiVax and CUBRC a $1 million contract over two years to establish best...
Setting the Standards for Generics
October is Rocking! Off to Amsterdam and Stockholm EpiVax Sets the Standards for the Generic Drug Industry Ok . . . that's an over-the-top headline! But read the press release! It reflects our excitement about our new contract with FDA and, the statement is actually...
PANDA® Screening
Peptide Abbreviated New Drug Application (PANDA)
EpiVax Advances “PANDA” Peptide Therapeutic Immunogenicity Screening Program
PROVIDENCE, R.I., Dec. 29, 2020 /PRNewswire/ -- EpiVax, Inc. ("EpiVax") today provides an update on the advancement of the company's peptide therapeutic immunogenicity assessment program. The PANDA (Peptide Abbreviated New Drug Application) immunogenicity...
Leadership Team
Rich-Henry Schabowsky, Ph.D., J.D. CEO & President[el_modal_popup modal_id="modal100" trigger_element_type="element_id" trigger_element_id="modal100" show_header="off" show_footer="off" modal_custom_padding="50px|50px|50px|50px|true|true" module_id="modal100"...