On September 9, 2019, KEI submitted a second request to the NIH that it investigate an apparent failure to disclose federal funding in patents in adeno-associated viral (AAV) gene therapies assigned to the Trustees of the University of Pennsylvania (UPenn).… Continue Reading
On September 12, 2019, Knowledge Ecology International (KEI), Union for Affordable Cancer Treatment (UACT), Universities Allied for Essential Medicines (UAEM), Social Security Works (SSW), and Clare Love filed an appeal with the National Institutes of Health (NIH). The signatories appealed… 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
KEI Briefing Note 2019:1 International Reference Pricing August 22, 2019 International Reference Pricing, often referred to as External Reference Pricing (ERP), is the practice of using a price in a foreign market as a benchmark for an acceptable price in… Continue Reading
(UPDATE: The NIH provided responses to our comments on August 14, 2019: 84 FR 33272 Response and 84 FR 33270 Response) On Monday July 29, 2019, Knowledge Ecology International (KEI) submitted joint comments to the NIH on behalf of KEI,… Continue Reading
On July 22, 2019, Knowledge Ecology International submitted a letter to the US House of Representative’s Committee on Oversight and Reform regarding the National Institutes of Health’s (NIH) lack of transparency in its exclusive licensing processes. Prior to executing an… Continue Reading
(UPDATE: The NIH provided a response to our comments on June 18, 2019) On June 7, 2019, KEI and UACT submitted comments to the Federal Register notice 84 FR 23798, on the “Prospective Grant of an Exclusive Patent License: The… Continue Reading
The documents linked below provide examples of companies disclosing information related to drug R&D costs to the U.S. Securities and Exchange Commission (SEC). These documents are in the Google’s cloud-based Docs program. You can view and/or download them (no Google… Continue Reading
On April 19, 2019, HealthGap, Knowledge Ecology International, Public Citizen, Social Security Works and the Union for Affordable Cancer Treatment filed comments on a proposed license on National Cancer Institute patented inventions to Senti Bio, for a next generation CAR… Continue Reading
In an order dated April 11, 2019, Judge Peter J. Messitte granted the NIH’s motion to dismiss for lack of jurisdiction in the lawsuit filed by KEI, which appealed an NIH decision to grant an exclusive license on a CAR… Continue Reading