Zolgensma R&D subsidies
Government Funded research
Charity and NIH funding related to Zolgensma
June 14, 2019 Zolgensma, the Novartis brand name for the new $2.1 million gene therapy for treatment of Spinal Muscular Atrophy (SMA), appears to be a remarkable medical breakthrough treatment. It is also, like all of the new cell- and… Continue Reading
The U.S. House of Representatives Oversight Hearing on PrEP
At today’s House Oversight Hearing on PrEP, one of issues will be access to Truvada (FTC+TDF), but also Descovy (FEMTRICITABINE+TENOFOVIR ALAFENAMIDE), a two drug combination, that uses TAF instead of TDF, and is less toxic than Truvada. The Goodrx price… Continue Reading
Bayh-Dole Act, US Manufacturing Waivers
University of Oklahoma request for U.S. Manufacturing Waiver for rHA, on the grounds that labor costs would be cheaper in China, and in subject revisions, also in Bulgaria. r_Part1_p0012-21.pdf r_r_r_1524003-01-0013_FOIA_Pratt.pdf r_r_r_UniversityofOklahomaEIR1524003-01-0018-p0009-p0052-3ms.pdf r_r_UniversityofOklahomaEIR1524003-01-0014Part1-p0002-p0010.pdf r_r_UniversityofOklahomaEIR1524003-01-0018-p0001-p0007.pdf r_r_US-Manufacturing-Waiver-1524003-01-0013-4-8-10.pdf 2011, May 5. HHS Approval of… Continue Reading
KEI Comment on the NIST Green Paper on Bayh-Dole technology transfer recommendations regarding march-in and government use rights
KEI Advisory on NIST Green Paper RE: Publication of NIST Green Paper on Innovation and Federally-funded R&D Date: Expected Release by NIST on Weds, April 24, 2019 Background On Wednesday, April 24, 2019, The National Institute of Standards and Technology… Continue Reading
Senti Bio License for Development and Commercialization of Next Generation Chimeric Antigen Receptor (CAR) Therapies for the Treatment of FMS-Like tyrosine kinase 3 (FLT3) Expressing Cancers
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
Litigation: KEI lawsuit over NIH/Gilead CAR T License Dismissed over Lack of Standing
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
Open letter on NIST Draft Green Paper on Bayh-Dole Act Policies and Regulations
Open letter on NIST Draft Green Paper on Bayh-Dole Act Policies and Regulations 5 April 2019 FMI: Claire Cassedy, claire.cassedy@keionlineorg +1.202.332.2670 Washington, 5 April 2019 – Eleven non-governmental organizations have sent a letter to members of the US Congress, highlighting… Continue Reading
Timeline regarding Bayh-Dole royalty-free requests
For a general timeline of the Bayh-Dole Act, see this page. 1999. September 3. Ralph Nader, James Love, and Robert Weissman requests the NIH Director Harold Varmus, M.D., to use royalty-free rights and give the WHO access to several U.S. government… Continue Reading
Timeline regard Bayh-Dole march-in right requests
For a general timeline of the Bayh-Dole Act, see this page. 1980. December 12. The Bayh-Dole Act was enacted into law as part of Public Law 96-517, including Section 203 that provide march-in rights. 1984. November 8. The Bayh-Dole statute was… Continue Reading