FDA States Submission Date of Gilead’s Coronavirus Treatment Orphan Status Application is ‘Confidential’

On Monday March 23, 2020, Gilead Sciences’ remdesivir received orphan designation from the US Food and Drug Administration (FDA) for the treatment of COVID-19. Remdesivir has been reported to be one of the candidates to potentially treat COVID-19, which the… Continue Reading

KEI Requests the NIH to Investigate Failure to Disclose Federal Funding in Opdivo and Keytruda Patents

On December 20, 2019, Knowledge Ecology International (KEI) filed a request to the National Institutes of Health (NIH) that it investigate an apparent failure to disclose federal funding in patents associated with cancer immunotherapies Opdivo and Keytruda. A court case… Continue Reading

KEI, UACT, Public Citizen, SSW, LWC Health Appeal NIH Grant of Exclusive License on Gene Therapy for Cancer to Intima Biosciences

On October 26, 2019, Knowledge Ecology International (KEI), Union for Affordable Cancer Treatment (UACT), Public Citizen, Social Security Works (SSW), LWC Health, Ruth Lopert, Manon Ress, and Terry Love filed an administrative appeal with the National Institutes of Health (NIH).… Continue Reading

KEI and UACT Comments Regarding NIH Exclusive License on GPC3-Expressing Cancer Treatment

On Tuesday November 12, 2019, KEI and the Union for Affordable Cancer Treatment (UACT) filed comments on the National Institutes of Health’s (NIH) “Prospective Grant of an Exclusive Patent License: The Development of an Anti-GPC3 Radionuclide Immunoconjugate for the Treatment… Continue Reading

KEI Comments to the NIH on Exclusive License to Opsis Therapeutics for Retinal Cell Therapies

On October 18, 2019, Knowledge Ecology International (KEI) submitted comments to the Federal Register Notice for the “Prospective Grant of an Exclusive Patent License: Compositions, Devices and Processes for Production and Delivery of Cell Grafts of Manufactured Retinal Pigment Epithelium… Continue Reading

KEI and UACT Comments to NIH on License to T-Cell Therapy for Cancer to Ziopharm Oncology

(Update: The NIH provided a response to our comments on November 15, 2019) On Friday October 18, 2019, Knowledge Ecology International and the Union for Affordable Cancer Treatment (UACT) submitted comments on the “Prospective Grant of an Exclusive Patent License:… Continue Reading

KEI and UACT Comments to NIH on License in AAV Vectors to Generation Bio and Spark Therapeutics

On Friday October 11, 2019, Knowledge Ecology International and the Union for Affordable Cancer Treatment (UACT) submitted comments to the Federal Register notice (84 FR 51171) for the “Prospective Grant of Exclusive Patent License: Capsid-Free AAV Vectors, Compositions, and Methods… Continue Reading

Joint Comments Regarding NIH Proposed Exclusive License to Intima Biosciences for Cancer Therapy (and NIH Response)

(UPDATE: The NIH provided a response to our comments on September 26, 2019) On September 13, 2019, Knowledge Ecology International (KEI), Union for Affordable Cancer Treatment (UACT), Public Citizen (PC), Social Security Works (SSW), LWC Health, Ruth Lopert, Manon Ress,… Continue Reading

KEI Request Re: Failure to Disclose Federal Funding in UPenn Bennett et al Patents for Gene Therapy to Treat Blindness

On September 9, 2019, KEI submitted a second request to the NIH that it investigate an apparent failure to disclose federal funding in patents in adeno-associated viral (AAV) gene therapies assigned to the Trustees of the University of Pennsylvania (UPenn).… Continue Reading