Collaborative Agreement to Aid in Setting Guidelines for Evaluating Potential Ebola Therapy
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By LabMedica International staff writers Posted on 25 Jul 2016 |
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Cooperation between an Israeli biopharmaceutical company and medical branches of the US government is designed to set ground rules for continued evaluation of an experimental therapy for Ebola virus disease.
RedHill Biopharma Ltd. (Tel Aviv, Israel), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases and cancer is set to begin collaborating with the [U.S.] National Institute of Allergy and Infectious Diseases (Bethesda, MD, USA).
The parties will be evaluating RedHill’s proprietary experimental therapy for the treatment of Ebola virus disease. This evaluation is intended to provide supportive data for discussions with the [U.S.] Food and Drug Administration for potential use of the Animal Rule pathway for approval. According to Food and Drug Administration guidelines, approval under the Animal Rule can be pursued only if human efficacy studies cannot be conducted because the conduct of such trials is unethical or not feasible.
Related Links:
RedHill Biopharma
[U.S.] National Institute of Allergy and Infectious Diseases
RedHill Biopharma Ltd. (Tel Aviv, Israel), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases and cancer is set to begin collaborating with the [U.S.] National Institute of Allergy and Infectious Diseases (Bethesda, MD, USA).
The parties will be evaluating RedHill’s proprietary experimental therapy for the treatment of Ebola virus disease. This evaluation is intended to provide supportive data for discussions with the [U.S.] Food and Drug Administration for potential use of the Animal Rule pathway for approval. According to Food and Drug Administration guidelines, approval under the Animal Rule can be pursued only if human efficacy studies cannot be conducted because the conduct of such trials is unethical or not feasible.
Related Links:
RedHill Biopharma
[U.S.] National Institute of Allergy and Infectious Diseases
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