Mismatch between the Cost to Perform Pediatric Extension Trials and the Cost to the Public of the FDA PED Monopoly Extension
Access to Medicine
Letter to FDA on the Cost to the Public of the Pediatric Trial Exclusivity Extension
Today, Knowledge Ecology International (KEI) submitted a letter to the Commissioner of the Food and Drug Administration (FDA) regarding the mismatch between the cost to perform pediatric extension trials and the cost to the public of the six month extension… Continue Reading
Delinkage embedded in the three UN Political Declarations on PPPR, tuberculosis, and universal health coverage
On 1 September 2023, Csaba Kőrösi, President of the 77th United Nations General Assembly, circulated three draft texts of political declarations related to the following processes: High-level meeting on pandemic prevention, preparedness and response(resolution77/275) High-level meeting on universal health coverage… Continue Reading
WHO Global vaccine market report (2022) flags transparency and vaccine inequity
In May 2023, the World Health Organization (WHO) published the global vaccine market report. Underpinning this technical report on vaccine market dynamics was a strong push by WHO’s Director-General, Tedros Adhanom Ghebreyesus, for increased transparency and equity; transparency is mentioned… Continue Reading
KEI Comments on NIH License to EnZeta Immunotherapies for Solid Tumors
On August 28, 2023, Knowledge Ecology International (KEI) provided comments to the National Institutes of Health (NIH) objecting to the “Prospective Grant of an Exclusive Patent License: Manufacture, Distribution, Sale and Use of T-Cell-Based Immunotherapies for Solid Tumors” (88 FR… Continue Reading
KEI August 18, 2023 Comments to the NIH licensing practices highlight failure to enforce Section 209 restrictions on exclusivity, transparency concerns, and KEI’s past engagement
As a part of the workshop hosted by the National Institutes of Health (NIH) on July 31, 2023 on the topic of, “Transforming Discoveries Into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer,” the NIH solicited public comments. In addition… Continue Reading
KEI Exchange with the NIH Regarding April 2023 EnZeta Prospective License Notice
KEI recently submitted comments to the National Institutes of Health (NIH) regarding its drastic cuts in the length of public comment periods for proposed exclusive licenses. In our comments, KEI discussed reasons that a longer comment period is important for… Continue Reading
KEI Comment on the Reduction of Number of Days the Public Can Comment on a Prospective NIH Exclusive Patent License
The National Institute of Health (NIH) recently held an all-day workshop titled, “Transforming Discoveries Into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer.” KEI Director James Love participated in the July 31st workshop, speaking on the panel on “How NIH… Continue Reading
KEI Questions to the NIH Regarding Prospective License of T-cell Cancer Therapy to EnZeta Immunotherapies
(Update: The NIH provided a response to our questions on August 17, 2023.) On August 11, 2023, Knowledge Ecology International (KEI) submitted questions to the National Institutes of Health regarding the “Prospective Grant of an Exclusive Patent License: Manufacture, Distribution,… Continue Reading
KEI Comments to the NIH Regarding the Prospective Grant of an Exclusive License to Elgia Therapeutics
On Friday August 4, 2023, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Caspase Inhibitors” (88 FR 47152) to Elgia Therapeutics, Inc.… Continue Reading