James Love's blog

NIH rulemaking on transparency of clinical trials

The NIH has a notice about a proposed rule that "clarifies and expands requirements for the submission of clinical trial registration and results information to the ClinicalTrials.gov database." Comments are due on or before February 19, 2015. We may ask the NIH to consider expanding the trials registry to include more information on the economics of clinical trials.

Here is a link to the Regulations.Gov docket for the proposed rule:

http://www.regulations.gov/#!documentDetail;D=NIH-2011-0003-0003

UACT sends letter to Tufts President, Chairman of Trustees, asking questions about R&D cost study

On November 24, 2014. the Union for Affordable Cancer Treatment (UACT) sent a letter to Anthony P. Monaco, Office of the President, Tufts University, with copies to Michael Baenen, the Tufts Chief of Staff, and Peter Dolan, Chairman of the Board of Trustees for Tufts University, regarding the Tufts University press conference to announce an estimate of $2.6 billion as the R&D costs for new drugs.

KEI comment on the new Tufts Study on Drug Development Costs

The Tuft Center for Study of Drug Development (CSDD) has just concluded a press conference, and issued a press release about their new study of drug development costs. The key number is $2.558 billion.

What to look for in the new Tufts study on drug development costs. 10 issues.

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:

Research note on oncology drugs, including trial size and orphan drug status

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 results

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

Elizabeth Rajasingh
November 17, 2014

Introduction

New leak of TPP consolidated text on intellectual property provides details of pandering to drug companies and publishers

For more information:
James Love, Knowledge Ecology International
email: james.love@keionline.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.

Matrix of Export Possibilities under Gilead HCV Licence

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.

WIPO General Assembly: Worst ever?

brazilIMG_20140930_234549887_1024.jpg
Brazil asks delegates to embrace work on copyright exceptions

European Medicines Agency (EMA) recommends approval of Harvoni, Gilead's all oral HCV combination product

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 Innovation

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.
Email: innovationstrategy@ostp.gov.
Re: Strategy for American Innovation
Date: September 23, 2014

FDA creates $500k prize for technology to improve detection of Salmonella

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.

Bayer's rejection of request for affordable Nexavar for Fathi Helmi Aboseda (Egypt)

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.

Biden presses Colombia to block biosimilar drugs

vp_portrait.jpegOn 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:

The Gilead HCV license: Glass half empty, or half full?

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.

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