James Love's blog | Knowledge Ecology International

NIH rulemaking on transparency of clinical trials

Posted on November 25, 2014 by James Love

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 Continue Reading →

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

Posted on November 25, 2014 by James Love

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. Continue Reading →

KEI comment on the new Tufts Study on Drug Development Costs

Posted on November 18, 2014 by James Love

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.

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

Posted on November 18, 2014 by James Love

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:

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

Posted on November 17, 2014 by James Love

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:

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

Posted on October 16, 2014 by James Love

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.

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Matrix of Export Possibilities under Gilead HCV Licence

Posted on October 2, 2014 by James Love

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.

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WIPO General Assembly: Worst ever?

Posted on October 1, 2014 by James Love

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

Posted on September 26, 2014 by James Love

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.”

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Comments of KEI regarding the White House OSTP call for comments on its Strategy for American Innovation

Posted on September 24, 2014 by James Love

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

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Brazil asks delegates to embrace work on copyright exceptions

Author: James Love

NIH rulemaking on transparency of clinical trials

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

KEI comment on the new Tufts Study on Drug Development Costs

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

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

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

Matrix of Export Possibilities under Gilead HCV Licence

WIPO General Assembly: Worst ever?

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

Comments of KEI regarding the White House OSTP call for comments on its Strategy for American Innovation

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