Medical Technologies

Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria unanimously endorses delinkage

paccarb_logo.jpgOn Thursday, the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria unanimously endorsed a report that included very powerful recommendations on delinkage. This is a link to the report that was approved.

This from the report:

  • Adoption of some form of a delinkage model as a pull incentive.

KEI asks HHS to use Bayh-Dole rights in Zinbryta patent (drug for multiple sclerosis)

Attached is a letter sent on September 14, 2017 to Andrew Bremberg, an Assistant to the President and the Director of the Domestic Policy Council at the White House, and Keagan Lenihan, a Senior Adviser to HHS Secretary Tom Price, regarding Zinbrytra (INN: daclizumab), a drug to approved by the FDA to treat multiple sclerosis. (PDF version here)

2017: Nanobernetics license

The KEI letter responding to FR notice is here.

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:

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.

2017: VeriLuce license of patents for pancreatic cancer treatment

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 Pancreatic Cancer", to VeriLuce Therapeutics, a very small firm located in Toronto, Ontario, Canada. KEI asked a number of questions about the transaction, and proposed conditions on the license.

Novel HIV drug approvals

Names, Date of initial approval, FDA#, Medical Review.

Retrovir, 3/19/1987, FDA#019655, Medical Review
Videx, 10/9/1991, FDA#020154, 020155, 020156, Medical Review
Zerit, 6/24/1994, FDA#020412, Medical Review
Epivir, 11/17/1995, FDA#020564, 020596 , Medical Review
Invirase, 12/6/1995, FDA#020628, Medical Review
Norvir, 3/1/1996, FDA#020659, Medical Review

2017: PathoVax license on Chimeric L1/L2 Protein . .. Human Papillomavirus Vaccines

On June 5, 2017, KEI provided comments to the NIH/NCI, on a prospective grant of an exclusive license to PathoVax, relating to HPV vaccines. On July 10, 2017, Kevin Chang responded (Copy of NIH response here), indicating the NIH will "consider your comments."

June 5, 2017

Kevin W. Chang, Ph.D.
Senior Technology Transfer Manager
NCI Technology Transfer Center
9609 Medical Center Drive,
RM 1E530 MSC 9702
Bethesda, MD 20892-9702
Telephone: (240)-276-6910;

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