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

FDA gives Gilead a seven year regulatory monopoly for remdesivir to treat COVID-19, on grounds it is an “Orphan” treating a rare disease

Today the FDA granted Gilead Orphan Drug status for remdesivir for the treatment of COVID-19, on grounds this is a rare disease. The morning of the designation, the U.S. had confirmed, through testing, more than 35 thousand cases, including 8,477… Continue Reading

KEI Comments on NIH Exclusive Licenses for CAR T Technologies to Kite/Gilead (and NIH Response)

(UPDATE: The NIH provided responses to our comments on August 14, 2019: 84 FR 33272  Response and  84 FR 33270 Response) On Monday July 29, 2019, Knowledge Ecology International (KEI) submitted joint comments to the NIH on behalf of KEI,… Continue Reading

Communications between Gilead and USTR regarding Malaysia compulsory license on HCV patents, 2017 to May 2018

The attached document is a 78 page PDF file obtained from USTR under the Freedom of Information Act (copy here), regarding communications between Gilead and USTR, over Malaysia’s decision to grant a compulsory license on patents for HCV treatments. This… Continue Reading

KEI Appeals NIH/NCI Decision to Proceed with License of CD30 CAR T technology to Gilead/Kite

KEI has appealed the NIH/NCI decision to proceed with the proposed exclusive license of anti-CD30 CAR T to Gilead, following an email of January 25, 2018 from Dr. David Lambertson of NCI rejecting all of KEI’s substantive suggestions and objections. KEI… Continue Reading