KEI Briefing Note 2021:3, The number of standard and material CRADAs executed by the NIH from 1985 to 2020 and the relationship to NIH reasonable pricing clause
CRADA
NIST Proposed Revisions to Bayh-Dole Act Regulations
New: Biden White House Executive Order opposes change in Bayh-Dole March-In regulations. (KEI has an email list to discuss this issue here: http://lists.keionline.org/mailman/listinfo/bayh-dole-regulations_lists.keionline.org) The Department of Commerce’s National Institute of Standards and Technology (NIST) published on January 4, 2021, a… Continue Reading
2016: Kite Pharma, KEI Comments on NIH Proposed Exclusive License for Cancer Treatment
Today, KEI submitted comments to the Notice published in the Federal Register on October 5, 2016, entitled “Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers.” KEI’s comments addressed issues with the NIH’s processes for granting exclusive licenses, and transparency in those licenses, resulting data, trials, pricing, and revenue.
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1994: Pricing of Drugs Developed with Public Funds
Comments Presented to the Second NIH CRADA Forum September 8, 1994 James Love Director, Taxpayer Assets Project P.O. Box 19367, Washington, DC 20036 I. Introduction My name is James Love. I work for the Center for Study of Responsive Law,… Continue Reading