Zolgensma, Novartis’s new $2.1 million gene therapy for children with spinal muscular atrophy (SMA), is a remarkable breakthrough with a steep price tag: the cost per child is $2.125 million. The treatment was developed using research funded by the National… Continue Reading
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
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
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 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
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
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 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
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