The cost of trials used to support the initial FDA approval of risdiplam (Evrysdi)
Access to Medicine
KEI Responses to Questions from HHS, USTR, Copyright Office and USPTO, Following Testimony at the 2025 Special 301 Review Hearing (docket number USTR-2024-0023)
The USTR Special 301 Committee presented KEI with four questions in follow-up to our earlier comments. Below are the questions and KEI’s responses, also available as PDF: KEI-Responses-to-Hearing-Questions-2025-Special-301 KEI Responses to Hearing Questions – 2025 Special 301 Review (docket number… Continue Reading
The New NIH Intramural Research Program Access Planning Policy
Introduction In January 2025, the National Institutes of Health (NIH) introduced a new NIH Intramural Research Program Access Planning Policy (“IRP Access Planning Policy” or “Policy”). An NIH web page provides links to several documents describing the policy: https://osp.od.nih.gov/policies/innovation-and-translation#tab1/ The… Continue Reading
KEI Comments to the NIH on Cancer Treatment License to Straightline Bio
On December 26, 2024, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Anti-KK-LC-1 T Cell Receptors for the Treatment of Cancer” (89 FR 99888) to StraightLine… Continue Reading
KEI Comments on NIH Exclusive License to Iovance for T-cell Vaccine for Cancer Treatment
On December 17, 2025, Knowledge Ecology International (KEI) provided comments to the National Institutes for Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Vaccine Augmented Tumor Infiltrating Lymphocytes for the Treatment of Cancer” (89 FR 95224) to… Continue Reading
KEI Comments on NIH Exclusive License to Columbia for Ebola Technology
On December 5, 2024, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) on the “Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Peptides and Peptide Microarrays for Detection and Differentiation of Antibody Responses to Ebola… Continue Reading
Proposal for Addition Of Risdiplam to WHO Model List Of Essential Medicines, for the treatment of Spinal Muscular Atrophy (SMA).
On November 1, 2024, Knowledge Ecology International (KEI) submitted a proposal for the addition of risdiplam to the World Health Organization’s (WHO) Model List of Essential Medicine (EML). You can access the full proposal here: risdiplam2WHOEML1Nov2024 The EML, updated every… Continue Reading
Comment on proposal by several countries to add language clarifying references to MAT or VMAT on the transfer of technology or know-how is without prejudice to other measures
Comment on proposal by several countries to add language clarifying references to MAT or VMAT on the transfer of technology or know-how is without prejudice to other measures KEI Briefing Note 2024:2A James Love Knowledge Ecology International (KEI) May 21,… Continue Reading
KEI Asks FDA to Publish Historical Orange Book Data
On October 3, 2023, Knowledge Ecology International (KEI) sent a letter to the FDA asking the agency to publish its historical Orange Book data. The Orange Book identifies patent and exclusivity data for FDA approved drug products. The FDA publicly… Continue Reading
September 16, 2024 version of the negotiating text for a WHO pandemic agreement