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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KEI statement regarding Gilead’s Acquisition of Kite Pharma

KEI statement regarding Gilead’s Acquisition of Kite Pharma.

“Congress should require the NIH to enforce the Bayh-Dole obligation to make the Kite Pharma Chimeric Antigen Receptors Technologies (CAR T) treatments available to the public on reasonable terms.

KEI notes that Kite reported spending $317 million in R&D from 2012 to June 30, 2017, and is selling the company for $11.9 billion.

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Workshop: Patents, the Public Interest and Two New Medical Technologies: CRISPR and CAR T

Workshop: Patents, the Public Interest and Two New Medical Technologies: Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), Chimeric Antigen Receptors (CAR) technologies

On September 15th, 2017, Knowledge Ecology International will be hosting a workshop on: “Patents, the Public Interest and Two New Medical Technologies: CRISPR and CAR T.”

If you are unable to attend in person, a livestream of the event will be available here

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2017: Salubris Biotherapuetics: Bispecific, Biparatopic Antibody-Drug Conjugate for Human Liver Cancers

(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) Attached are the August 8, 2017 KEI comments regarding the prospective grant of an exclusive patent license by the NIH to Salubris Biotherapuetics for the development of… Continue Reading

2017: KEI initial comments on NIH proposed grant of exclusive license on liver cancer treatment to Salubris

On August 8, 2017, Knowledge Ecology International (KEI) submitted comments on the proposed grant of an exclusive license from the National Institutes of Health (NIH) and Department of Health and Human Services (HHS) to Salubris Biotherapuetics, Inc, a corporation headquartered in Guangdong, China, for an important new technology that could be used Continue Reading

NIH response to KEI request for NIH policy on on the licensing of federally-funded CRISPR patented inventions.

On June 6, 2017, KEI wrote to Dr. Thomas Price, Secretary of Health and Human Services (HHS), and Dr. Francis S. Collins, Director of the National Institutes of Health (NIH) requesting the HHS develop a policy on the licensing of federally-funded CRISPR patented inventions. A copy of our letter is available here: /node/2801.

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2017: VeriLuce license of patents for pancreatic cancer treatment

(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) On July 10, 2017, the NIH issued a notice on “Prospective Grant of Exclusive Patent License: Composition and Methods for Delivering Inhibitory Oligonucleotides for the Treatment of… Continue Reading

KEI and Médecins Sans Frontières propose contractual terms to protect access and affordability of Zika vaccine

25 July 2017
FOR IMMEDIATE RELEASE
CONTACT: Kim Treanor, kim.treanor@keionline.org or +1 (202) 332-2670

Washington, 25 July 2017 – Knowledge Ecology International (KEI) and Médecins Sans Frontières (MSF) have sent a letter today to the Command Judge Advocate of the U.S. Army Medical Research and Materiel Command (USAMRMC), recommending two specific contractual terms for the proposed license of the US Army’s Zika vaccine technology to Sanofi Pasteur.

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2017: NantBioScience – Commercial Application and Use of Fulvestrant in Combination Therapy for the Treatment of Cancers

(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) In 2016, the NIH signed a CRADA with NantBioScience, a company lead by Patrick Soon-Shiong, MD. to develop “Further Develop Recombinant NK Cells and Monoclonal Antibodies as… Continue Reading