Author: 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

(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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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.

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(More on Colombia here: /colombia)
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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: https://www.keionline.org/node/2082.

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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:

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Attached are two annexes from our 2014 USTR Special 301 comments Continue Reading →

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.

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KEI is creating a timeline for various events relating to the discovery and the development of diagnostics, vaccines and drugs for Hepatitis. A working draft of the timeline is available here. Continue Reading →