KEI comments to FDA on Prospective Exclusive Patent License for Diagnostic for SARS, SARS-CoV-2, Other Viruses, Bacteria and Bacterial Serovar, to Advion

To: Ken Millburne Technology Transfer Program Food and Drug Administration Via email: Kenneth.millburne@fda.hhs.gov From: James Love Knowledge Ecology International 1621 Connecticut Avenue NW, Suite 500 Washington, DC 20009 https://keionline.org Date: November 30, 2020 Re: Prospective Grant of an Exclusive Patent… Continue Reading

Comments of Knowledge Ecology International Regarding “Purple Book Enhancement; Establishment of a Public Docket; Request for Comments” (FDA-2020-N-0437)

May 4, 2020 Comments of Knowledge Ecology International Regarding “Purple Book Enhancement; Establishment of a Public Docket; Request for Comments” (FDA-2020-N-0437) Knowledge Ecology International (KEI) provides the following comments regarding the Food and Drug Administration [FDA]’s Purple Book Enhancement. Our… Continue Reading

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

Zolgensma

Zolgensma is a gene therapy for spinal muscular atrophy (SMA) that was approved by the US FDA in May 2019, at a price of $2.1 million per patient. Zolgensma was licensed from a children’s hospital where it was developed on… Continue Reading