James Love's blog
When the new Tufts study on the costs of R&D for development of a new drug is released Tuesday at 10AM, here are 10 things to look for:
We will be sharing some data on 2005 to 2014 oncology approvals, including the size of the trials cited in the medical review, and the orphan status.
The spreadsheet we are working on updating is published here:
KEI Research Note: Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary resultsSubmitted by James Love on 17. November 2014 - 11:50
A copy of the research note is also available here as a pdf file: http://keionline.org/sites/default/files/kei-rn-2014-3.pdf
KEI Research Note 2014:3
Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results
November 17, 2014
New leak of TPP consolidated text on intellectual property provides details of pandering to drug companies and publishersSubmitted by James Love on 16. October 2014 - 5:03
For more information:
James Love, Knowledge Ecology International
email: firstname.lastname@example.org, +1.202.361.3040
The May 16, 2014 version of the consolidated negotiating text for the Intellectual Property Chapter for the Trans-Pacific Partnership (TPP) agreement is a long, complex document that taken as a whole is designed to expand and extend monopolies on knowledge goods, including in particular publisher-owned copyrights, patents on inventions, and monopoly rights in data used to register new drugs, vaccines and agricultural chemical products.
KEI was asked to make a presentation on Hepatitis C, on September 30, 2014, at a lunch seminar at UNITAID. I am attaching a PDF of the slides I used, as well as an eight page memo that takes a look at the recent Gilead license. The memo on the license was last edited on September 30, 2014, and is presented as a draft that may be revised in the future.
|Brazil asks delegates to embrace work on copyright exceptions|
European Medicines Agency (EMA) recommends approval of Harvoni, Gilead's all oral HCV combination productSubmitted by James Love on 26. September 2014 - 8:37
The European Medicines Agency (EMA) is recommending approval of Harvoni, a combination of 9mg of ledipasvir (LDV) and 400mg of sofosbuvir (SOF), for the treatment of chronic hepatitis C virus (HCV) infection in adults. This is the "all oral" combination product, delivered in daily does of just 490 mg of API, for the "cure of patients with chronic HCV infection without the need for treatments involving interferons."
Comments of KEI regarding the White House OSTP call for comments on its Strategy for American InnovationSubmitted by James Love on 23. September 2014 - 22:19
Comments of KEI regarding the White House OSTP call for comments on its Strategy for American Innovation
(PDF of comments here)
Attn: Dan Correa, Office of Science and Technology Policy, Eisenhower Executive Office Building, 1650 Pennsylvania Ave NW., Washington, DC 20504.
Re: Strategy for American Innovation
Date: September 23, 2014
This just published by the US FDA:
The U.S. Food and Drug Administration is asking for potential breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce.
The 2014 FDA Food Safety Challenge was developed under the America COMPETES Reauthorization Act of 2010, which grants all federal agencies broad authority to conduct prize competitions to spur innovation, solve tough problems, and advance their core missions. This challenge offers a total prize pool of $500,000.
Today we received news from Nina Mahmud that her father-in-law, Fathi Helmi Aboseda, has passed away in Egypt. Mr. Aboseda was suffering from liver cancer. Earlier this year, Nina Mahmud had contacted Bayer and KEI asking for help in finding affordable copies of sorafenib, a drug for liver and kidney cancer sold by Bayer under the trade name Nexavar, a drug that was extending and improving the quality of his life. The price of Nexavar in Egypt was $900 per week, and Mr. Aboseda had used his entire life savings to buy the drug.
On September 8, 2014, Vice President Joe Biden wrote to Juan Manuel Santos Calderón, the President of Colombia. In the letter, Biden registered a complaint about the regulations in Colombia to register biosimilar drugs. A copy of the letter from Vice President Joe Biden is available here, and includes this quote:
On Monday, September 15, 2014, Gilead announced licensing agreements with 7 generic drug manufacturers, for two of its HCV drugs, including sofosbuvir, which is currently the most important HCV drug, and the basis for Gilead’s value to shareholders. KEI's statement from Monday, and links to other NGO comments are here: http://www.keionline.org/node/2082.
OMB's Revised Guidance on Appointment of Lobbyists to Federal Advisory Committees, Boards, and CommissionsSubmitted by James Love on 15. August 2014 - 8:58
Following litigation by several lobbyists, OMB is revising its guidance on the appointment of lobbyists to federal advisory committees, boards, and commissions. Now, lobbyists can serve on these committees, including the USTR advisory boards. Money quote:
Attached are two annexes from our 2014 USTR Special 301 comments
On July 24, 2014, the Medicines Patent Pool announced welcome modifications and expansions of their licensing agreement with Gilead. Among the significant changes were the addition of a new drug, tenofovir alafenamide (TAF), formerly known as GS-7340. TAF is a nucleotide reverse transcriptase inhibitor, and a prodrug of tenofovir. TAF is considered to have similar antiretroviral efficacy to tenofovir disoproxil fumarate (TDF), the drug it may replace in use, but can be administered with smaller doses and with less adverse effect on kidneys and bones.