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
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 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
On August 20, 2018, KEI filed comments in response to the US Federal Trade Commission’s hearings and public comment process to address, “Competition and Consumer Protection in the 21st Century.” The goal of the process is to examine, “whether broad-based… Continue Reading
Knowledge Ecology International and 43 other health-care interested groups are calling on Congress to pass the CREATES Act. The CREATES Act, or the “Creating and Restoring Equal Access To Equivalent Samples Act of 2017”, is a bipartisan proposal to speed… Continue Reading