The National Institute of Standards and Technology (NIST) issued a Request for Information on December 8, 2023 regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593). The request follows a nearly year-long interagency… Continue Reading
KEI submitted comments to the National Institute of Standards and Technology (NIST) in response to the Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593) concerning Bayh-Dole rights and the… Continue Reading
On December 8, 2023, the National Institute of Standards and Technology (NIST) issued a Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593). Today KEI submitted comments to NIST regarding… Continue Reading
Knowledge Ecology International (KEI) filed comments with the National Institutes of Health (NIH) on March 16, 2022 regarding the “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Chimeric Antigen Receptor T-Cell Therapies (CAR-T) That are Specific to… Continue Reading
(More on this topic here: https://www.keionline.org/xtandi2021) On February 24, 2022, Senators Thom Tillis and Marsha Blackburn sent a letter to HHS Secretary Xavier Becerra (PDF copy). The letter refers to “petitions to march-in on a pharmaceutical product purely based on… Continue Reading
2016-Mar25-email-Re-Dir-Sig-Response-March-In-Letter 2016-Dec18-Email-Chain-Re-Reasonable-Pricing-Clauses 2016-Dec24-Email-Seeking-Help-Re-NCI-Criticism-Response 2016-Dec25-Email-Seeking-Help-NCI-Rebuttal 2016Mar30-Email-Sen-Sanders-Letter 2016Apr26-Email-Nader-Response 2016Jun27-Email-re-March-in Process 2017-Jan3-Email-Re-Help-NCI-Rebuttal 2017Jan5-Email-Regarding-Kite-License-Applicants 2017Apr24-Email-Chain-Re-Xtandi-Appeal 2017Nov20-email-helping-Allen 2017-Dec7-Email-Re-Placing-Op-Ed 2019Apr16-email-CAR T-information
Published in an article by Sydney Lupkin of NPR, the Pfizer-US government contract for the COVID-19 therapeutic Paxlovid contains terms of interest in broader drug pricing discussions. The Pfizer contract includes a “Most Favored Nation Clause” (H.7), which provides that… Continue Reading
On October 1, 2021, the WHO published the new edition of its Model Lists (the EML) of Essential Medicines and Essential Medicines for Children. WHO Documents Press Release Executive Summary World Health Organization model list of essential medicines: 22nd list… Continue Reading
On September 9, 2021, the Secretary of HHS, Xavier Becerra, pushed a 29 page report on proposals to address high drug prices. “Report To The White House Competition Council, on Comprehensive Plan for Addressing High Drug Prices. A Report in… Continue Reading
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