Zolgensma

Zolgensma is a gene therapy for spinal muscular atrophy (SMA) that was approved by the US FDA in May 2019, at a price of $2.1 million per patient. Zolgensma was licensed from a children’s hospital where it was developed on… 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

Latin America, compulsory licensing

Brazil 1990-2000 Comments for the Working Group On Intellectual Property Rights, Third Trade Ministerial and Americas Business Forum, Belo Horizonte, Brazil, May 13-16,1997, 1997-05-16 2005 U.S. DoS Cable: U.S. PHARMA FIRMS THREATENED WITH LICENSING (Brazil), June 3, 2005. U.S. DoS… Continue Reading

2017: Kymriah, the Novartis $475,000 CAR T treatment, received 50 percent Orphan Drug tax credit on trials

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

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