Revised February 14, 2022 Early 2000 UCLA claims work that led to the development of enzalutamide began at UCLA in early 2000. 2005 May 13, 2005. Priority date for the three patents in the Xtandi Orange Book. Patents 7709517, 8183274… Continue Reading
Following the publication of the US government contract with Pfizer for the COVID-19 therapeutic Paxlovid, the petitioners of the Xtandi government use request wrote to the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH)… Continue Reading
The Department of Health and Human Services (HHS) and National Institutes of Health (NIH) is currently reviewing whether to proceed with the request that the government use its rights in the prostate cancer drug Xtandi, in order to enable generic… Continue Reading
On February 2, 2022, Drs. Ameet Sarpatwari, Aaron S. Kesselheim, Jerry Avorn, and Benjamin N. Rome of Harvard Medical School and Dr. Michael S. Sinha of Northeastern University and Loyola University sent a letter to HHS Secretary Xavier Becerra in… Continue Reading
On Monday January 31, 2022, Knowledge Ecology International (KEI) Doctors Without Borders/Médecins Sans Frontières (MSF) USA, Doctors for America, the Drugs for Neglected Diseases Initiative, Professor Chris Morten of Columbia Law School, and 33 supporting organizations sent a letter to… Continue Reading
New: February 23, 2022. UAEM sends letter to HHS and NIH, asking to recuse the NIH technology transfer official, Mark Rohrbaugh, from having any decision-making role in the response to the 2022 petition to march-in and exercise other rights in… Continue Reading
On April 6, 2020, KEI received a response from the National Institutes of Health (NIH) to a letter we sent to DHHS Secretary Alex Azar on March 13, 2020 regarding three areas in Section 202 of the Bayh-Dole Act that… Continue Reading
For more on KEI’s work on COVID-19, see keonline.org/coronavirus. As the US and other governments begin to expend large amounts of money on research and development related to the control, prevention and treatment of the coronavirus pandemic, there are important… Continue Reading
The following are comments by the KEI on the HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, in response to notice in the Federal Register, 83 FR 22692. Overall, the Blueprint is very weak, and won’t do much… Continue Reading
On Friday May 11, 2018, the Department of Health and Human Services (DHHS) held its annual listening session in advance of the upcoming Seventy-First World Health Assembly. Comments were limited to 2 minutes, with no time set aside for a… Continue Reading