These are the KEI comments on the questions raised by the FDA in the 85 FR 33165 and 85 FR 33169 Federal Register notices. KEI-comments-FDAOrange Book-31aug2020 KEI comments to the FDA relating to the Approved Drug Products With Therapeutic Equivalence… Continue Reading
(Update: The NIH has provided a response to our comments on August 31, 2020) On August 28, 2020, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) submitted comments to the National Institutes of Health (NIH) “Prospective… Continue Reading
(More on Moderna here: https://www.keionline.org/moderna) On August 28, 2020, KEI asked DARPA to investigate apparent failures to disclose U.S. government funding into Moderna’s patents and applications. The request, which was first covered by the Washington Post, and subsequently by Statnews,… Continue Reading
(More on Moderna here: https://www.keionline.org/moderna) Luis Gil Abinader has taken a deep dive into Moderna’s surprising practice of never declaring government funding in its 126 patents and 154 patent applications, despite having had funding from multiple federal agencies. One outcome… Continue Reading
(Update: The NIH provided a response to our comments on August 24, 2020) On August 20, 2020, Knowledge Ecology International (KEI) submitted comments regarding the prospective grant of an exclusive license by the National Institutes of Health (NIH) to PreciThera,… Continue Reading
On 29 June 2020, the World Health Organization (WHO) published a document (A73/INF./3, 29 June 2020), entitled, “Voluntary contributions by fund and by contributor, 2019“. Total voluntary contributions to WHO’s Total General Fund in 2019 amounted to $2,443,961,432; in 2018,… Continue Reading
On August 14, 2020, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) submitted comments to the NIH’s “Prospective Grant of an Exclusive Patent License: Allogeneic Therapy Using Chimeric Antigen Receptors Targeting GPC3” (85 FR 45912). The… Continue Reading
The entire world is struggling to deal with the COVID 19 pandemic, and even in the favorable scenarios, facing a protracted recovery. Among the many casualties of the pandemics are the closing of schools and restrictions of access to libraries.… Continue Reading
On Friday, 24 July 2020, Italy officially published the long-anticipated Pricing and Reimbursement Decree in the Gazzetta Ufficiale della Repubblica Italiana setting in motion Italy’s place as the first country to implement the WHO transparency resolution (WHA72.8). In statement before… Continue Reading