KEI has appealed the NIH/NCI decision to proceed with the proposed exclusive license of anti-CD30 CAR T to Gilead, following an email of January 25, 2018 from Dr. David Lambertson of NCI rejecting all of KEI’s substantive suggestions and objections. KEI… Continue Reading
On Tuesday February 20, 2018, the U.S. Federal Trade Commission approved the Celgene acquisition of Juno, without requiring divestitures. The European Commission did not review the merger. KEI’s February 16, 2018 letter opposing the acquisition is available here. The following… Continue Reading
On February 14, 2018, KEI meet with the FTC to express our opposition to Celgene’s proposed acquisition of Juno Therapeutics. Celgene-Juno-KEI-FTC16Feb2018 The Celgene acquisition of Juno Therapeutics would give Celgene control over competing candidates for the treatment of multiple myeloma… Continue Reading
On February 14, the NIH was asked what the budget was for the Phase 1 clinical trial of the anti-CD30 CAR T technology that is the subject of a proposed exclusive patent license to Kite/Gilead. The clinicaltrials.gov identifier for the… Continue Reading
(More on government funded inventions here) 2015 2015: Virotas Biopharmaceuticals. KEI and Public Citizen ask NIH for safeguards in license for HCV patents, April 14, 2015. 2015: NIH refuses to give information about principals in company seeking exclusive license to… Continue Reading
The World Health Organization’s (WHO) Executive Board is expected to discuss agenda item 3.8 on Preparation for the third High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases, to be held in 2018 the either… Continue Reading
Contact: Kim Treanor 202-332-2670; kim.treanor@keionline.org January 5, 2018 The National Institutes of Health (NIH) has proposed an exclusive license with Gilead for certain patent applications for inventions that target CD-30 proteins and CAR T technologies. The proposed license is to… Continue Reading
On October 17, 2017, KEI sent a letter to the NIH regarding the failure of the University of Pennsylvania to disclose federal funding of five patented inventions for CAR T.
Today (October 18, 2017), we received this statement from the University:
“We have reviewed the letter and have confirmed that each of these patents was reported to the government as having NIH funding.
Missing in the reporting on the Novartis price for Kymriah, its new $475,000 CAR T treatment, is that Novartis received an Orphan Drug designation in February 3, 2015, and sequently received a tax credit subsidy from the United States equal to 50 percent of the cost of qualifying clinical trials.
From the FDA database on Orphan Designations:
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=463114