Texas A&M Vaccine Manufacturing Contract Shows that cGMP Manufacturing of COVID-19 Vaccines Can Start in Five Months 

A $265 million COVID-19 vaccine manufacturing contract between the Department of Health and Human Services (HHS) and the Texas A&M University System (TAMUS) to manufacture the Novavax and other COVID-19 vaccines demonstrates that a manufacturing facility can be retrofitted to… Continue Reading

WTO TRIPS Council discussions on the transparency of R&D costs and the pricing of medicines: The Good, The Bad, and The Ugly

In February 2020, the World Trade Organization (WTO) de-restricted the minutes of the TRIPS Council’s October 2019 session. While the official minutes (IP/C/M/93/Add.1) were circulated to WTO members on 9 December 2019, the October 2019 minutes were only available to… Continue Reading

KEI Comments on NIH Exclusive Licenses for CAR T Technologies to Kite/Gilead (and NIH Response)

(UPDATE: The NIH provided responses to our comments on August 14, 2019: 84 FR 33272  Response and  84 FR 33270 Response) On Monday July 29, 2019, Knowledge Ecology International (KEI) submitted joint comments to the NIH on behalf of KEI,… Continue Reading

KEI Statement on Adoption of the WHA72 Transparency Resolution

Today the World Health Assembly (WHA) approved A72/A/CONF./2 Rev.1 as a resolution, titled “Improving the transparency of markets for medicines, vaccines, and other health products.” Link to the resolution: http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_ACONF2Rev1-en.pdf When the text was made available, I sent out a… Continue Reading

Examples of SEC disclosures

The documents linked below provide examples of companies disclosing information related to drug R&D costs to the U.S. Securities and Exchange Commission (SEC). These documents are in the Google’s cloud-based Docs program. You can view and/or download them (no Google… Continue Reading

KEI Memo on U.S. Legislation to cap price increases on prescription drugs and to enhance the transparency of R&D costs

On April 30, 2019, KEI issued a memorandum to Congress concerning recent proposed measures to cap drug price increases and to increase the transparency of pharmaceutical research and development costs.  Congress is currently considering several bills that touch on these… Continue Reading

Italy’s Draft WHO resolution: Improving the transparency of markets for drugs, vaccines and other health-related technologies

On 1 February 2019, Dr. Giulia Grillo, Italy’s Minister of Health, sent a letter to Dr. Tedros Adhanom Ghebreyesus, the Director General of the World Health Organization (WHO), with an attached “first draft” of a resolution on “Improving the transparency… Continue Reading