On Monday, October 15, 2018, Judge Peter J. Messitte of the United States District Court, District of Maryland, convened a hearing on a motion by the NIH to dismiss a lawsuit (Case 8:18-cv-01130-PJM) by KEI regarding the decision by the… Continue Reading
The United States-Mexico-Canada Agreement (USMCA) provisions on the term of protection of test data for new pharmaceutical products has received considerable attention, and in some cases, some inaccurate reports on the agreement have conflated the term for test data protection… Continue Reading
The text of the proposed new U.S.-Canada-Mexico trade agreement is out, and available here from USTR. The agreement includes 34 chapters, 11 agreement annexes and 12 side letters. This is the first time the public has seen the text, even… Continue Reading
On September 18, 2018, negotiations closed on what may be the final draft of the “Political Declaration of the third high-level meeting of the General Assembly on the prevention and control of non-communicable diseases.” The Declaration addresses the measures UN… Continue Reading
USTR has provided some details of the new trade agreement with Mexico, here. As usual, the agreement seems to favor drug companies and holders of copyrights, although few of the details are known. Among the specifics revealed are a proposed… Continue Reading
The following is a question for the record from Senator Sherrod Brown, and a response from Alex Azar, in connection with Azar’s confirmation hearing. Questions for the Record January 9, 2018 Hearing to Consider the Nomination of Alex Azar to… Continue Reading
This is the July 26, 2018 draft of the UN declaration on NCDs. NCD-Draft-co-facilitators-text-26July2018 [The earlier July 16, 2018 draft is available here: NCD-POL-DECLARATION-16JUL2018] To nobody’s surprise, the July 26, 2018 version is very weak. In the July 26, 2018… Continue Reading
The new House democrats medicare negotiations bill represents a turning point, with broad support for using robust compulsory licensing authority to protect access if negotiations on prices break down. The press conference announcing the bill featured several Democratic members of… Continue Reading
Attached are comments from 8 health and fair groups regarding a prospective grant of an exclusive license to NIH owned patent, for the development of an Anti-Mesothelin Chimeric Antigen Receptor (CAR) for the treatment of human Cancer, to Atara Biotherapeutics… Continue Reading
UPDATE: On July 13, 2018, KEI received a response to our comments on the prospective license to be given to ERYTHRYx Therapeutics. The brief response simply stated that NIH had already assessed the company to meet their technical and financial… Continue Reading