University of Pittsburgh Failure to Disclose Federal Funding for Patents on Vizamyl

On May 18, 2018 KEI requested that the Department of Health and Human Services (HHS) investigate the failure to disclose National Institutes of Health (NIH) funding in four patents on Vizamyl (INN flutemetamol F 18), which is used to evaluate… Continue Reading

Six organizations ask HHS Secretary Azar to take title of 5 patents on Exondys 51, as remedy to failure by inventors to disclose NIH funding

FOR IMMEDIATE RELEASE April 5, 2018 kim.treanor@keionline.org (202)-332-2670 Six organizations are asking Department of Health and Human Services Secretary Alex Azar to take actions to lower the price of eteplirsen, a drug sold under the brand name Exondys 51, to… Continue Reading

James Griffin, Dana-Farber Cancer Institute and Novartis failure to disclose NIH funding for patents on leukemia drug midostaurin (Trade name Rydapt)

On March 21, 2018, KEI asked the NIH to investigate the failure of James Griffin, the Dana-Farber Cancer Institute and Novartis to disclose millions of dollars in NIH grants related to two patents for the leukemia drug midostaurin, marketed by… Continue Reading

Reasonable Pricing Clause

1994. The 1994 NIH Report on CRADAs and the Reasonable Pricing Clause 1994. September 8. James Love. Pricing of Drugs Developed with Public Funds. Comments Presented to the Second NIH CRADA Forum. 1995. April 11. NIH Notice Rescinding the Reasonable… Continue Reading

KEI Appeals NIH/NCI Decision to Proceed with License of CD30 CAR T technology to Gilead/Kite

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

Zinbryta

2017 KEI asks HHS to use Bayh-Dole rights in Zinbryta patent (drug for multiple sclerosis), September 15, 2017.

2012-2013-nih-march-in-request-for-ritonavir

Pages on the 2012-2013 NIH Request October 15, 2013. 15 frequently asked questions about the 2012 ritonavir March-In petition /node/1815 October 8, 2013. Congress asked to hold hearings on NIH failure to address abuses of government financed medical inventions /node/1805… Continue Reading

2010 Fabrazyme March-In Request

More on Fabry here: https://keionline.org/fabry NIH rejects Fabrazyme March-In Petition December 7, 2010. Press release from Fabry patients: DHHS denies patient’s march-in request to end Genzyme’s rationing of treatment for Fabry Disease citing that FDA rules block manufactures from supplying… Continue Reading