NIH funded research involving trastuzumab (marketed by Roche under the trade name Herceptin)

13 December 2010

Drugs@FDA
Drug Name(s) HERCEPTIN (Brand Name Drug)
FDA Application No. (BLA) 103792
Active Ingredient(s) TRASTUZUMAB
Company GENENTECH (Roche acquired a majority ownership in 1990, and full ownership in March 2009.)
Original Approval or Tentative Approval Date September 25, 1998

What is Herceptin? How does it work?

Continue Reading

Uncategorized

Statements by KEI and others on NIH rejection of Fabrazyme March-In Request

For background on the Fabrazyme case, see: https://www.keionline.org/fabrazyme

The following statements were made today by civil society on the NIH rejection of the Fabrazyme March-in Request Petition. Contact Judit Rius at judit.rius@keionline.org if your organization would like to submit an statement.

Statement by James Love, Director of Knowledge Ecology International (KEI) (Contact: 1.202.361.3040)

Continue Reading

Microsoft, Gates Foundation Timeline

November 29, 2010 Revised January 4, 2011 Introduction This timeline contains a number of selected data points concerning Microsoft and the Bill and Melinda Gates Foundation (BMGF). The motivations for this timeline, which features entries for both Microsoft and the… Continue Reading

Statement of the United States to WTO TRIPS Council on the Paragraph 6 System

The following statement was delivered by USTR at the WTO Council for TRIPS Annual Review of the Paragraph 6 System on Wednesday, 27 October 2010.

Statement of the United States
Agenda item F, Annual Review of the Paragraph 6 System
Topic 5

Mr. Chairman

We are pleased to be here today to participate in the annual review on the implementation of paragraph 6 of the Doha Declaration.

Continue Reading

Uncategorized

Remarks by UNAIDS Secretariat and on behalf of UNDP: Capacity building on the Paragraph 6 System and related TRIPS flexibilities

The following statement was delivered on Wednesday, 27 October 2010 by the UNAIDS Secretariat and on behalf of UNDP during the Annual Review of Paragraph 6.

World Trade Organization
Council for TRIPS – Regular Session
Annual Review of Paragraph 6
Doha Declaration on the TRIPS Agreement and Public Health
Agenda item 4 – Capacity building on the Paragraph 6 System and related TRIPS flexibilities
Remarks by UNAIDS Secretariat and on behalf of UNDP
27 October 2010

Mr Chair, Distinguished Delegates

Continue Reading

Uncategorized

Canada’s Intervention to TRIPS Council: Experience using the System (Apotex-Rwanda Case)

On Wednesday, 27 October 2010, Canada delivered the three interventions to the WTO TRIPS Council related to the review of the Paragraph 6 system. The first intervention below details the Canadian experience using the Paragraph 6 system in the case of Apotex and Rwanda.

CANADA Intervention: (1) Experience using the System (Apotex-Rwanda Case)

As we recall, the 2003 WTO Decision on TRIPS and Public Health was an intensely negotiated decision that garnered unanimous support from all WTO Members.

Continue Reading

Uncategorized

Michèle Rivasi asks question about ACTA and Access to Medicine

225px-michel-rivasi.jpg Michèle Rivasi, a Member of the European Parliament, representing South East France for The Greens, has asked the European Commission: “Given the possible impacts of the inclusion of patents the agreement on access to medicines and on innovation, would the Commission consider accepting the exclusion of patents from the agreement as proposed by a number of ACTA negotiating parties?” The full text of her question follows:

Continue Reading

Uncategorized