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

House Coronavirus Bill Provision Could be Used for COVID-19/Coronavirus-Related R&D without Public-Interest Safeguards

A House coronavirus stimulus bill contains a provision concerning the use of Other Transactions Authority to fund COVID-19 diagnostics. The provision appears to authorize the Department of Homeland Security (DHS) to award $2.2 billion to private sector companies to develop… Continue Reading

President and Minister of Health of Costa Rica ask WHO to create global pool for rights in COVID-19 related technologies

(KEI blogs and other work on COVID-19 are here: https://www.keionline.org/coronavirus) A letter from Costa Rica, signed by Carlos Alarado Quesada, the President, and Dr. Daniel Salas Peraza, the Minister of Health, to Dr. Tedros Adhanom Ghebreyesus, was sent this evening… 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 Letter to Speaker Pelosi Regarding Use of “Other Transaction Authority” (OTA) in Coronavirus Bill to Escape Bayh-Dole Public Interest Safeguards

For more on KEI’s work on COVID-19, see keionline.org/coronavirus. On March 23, 2020, Knowledge Ecology International (KEI) sent a letter to Speaker Nancy Pelosi regarding a provision in the current draft of the Senate version of the coronavirus funding bill… Continue Reading

Israel issues compulsory license to allow the government to import generic versions of Kaletra

(More on COVID-19 here: https://www.keionline.org/coronavirus) On Wednesday, 18 March 2020 (22nd of Adar, 5780), Israel’s Minister of Health, MP Rabbi Yaacov Litzman, issued a Permit to the State to Exploit an Invention Pursuant to Chapter Six, Article Three of the… Continue Reading

Legislative Committee in Ecuador approves resolution on compulsory licensing of patents relating to the coronavirus

For more on KEI’s work on COVID-19, see keonline.org/coronavirus. Today, the Education, Culture, Science and Technology Commission of the National Assembly in Ecuador approved a resolution asking the Minister of Health to issue compulsory licenses over patents related to coronavirus… Continue Reading

KEI Blogs and Reseach notes on COVID-19/Coronavirus

COVID-19 Gov’t Contracts: KEI has obtained numerous contracts between the federal government and pharmaceutical companies regarding COVID-19 medical technologies via the Freedom of Information act. For these and other contracts, please see: https://www.keionline.org/covid-contracts. COVID-19 Vaccine Manufacturing: KEI has gathered data… Continue Reading

English translation of Chile “RESOLUTION FOR THE GRANTING OF NON-VOLUNTARY LICENSES REFERRED TO IN ARTICLE 51º Nº 2 OF INDUSTRIAL PROPERTY LAW Nº 19.030 TO FACILITATE ACCESS AND AVAILABILITY OF MEDICINES AND TECHNOLOGIES FOR THE PREVENTION, TREATMENT AND CURE OF CORONAVIRUS COVID-19”

The following is an English translation resolution 896, that was adopted by the Chile Chamber of Deputies on March 17, 2020, by a vote of 127 to 0. The original resolution, in Spanish, is available here. KEI has a blog… Continue Reading