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In the first seven months of 2011 (January 14 to July 20) , the US FDA has already approved 18 new molecular entity drugs. These are some notes on the approvals:

• All of the NME products are considered pharmaceutical drugs, and received approval under FDA procedures for New Drug Applications (NDA).
• Despite the trends indiciating shifts to biologic products from pharmaceutical drugs, none of the 2011 products introduced to date were biologics.
• One third (6 of 18) received Priority review status. 12 of 18 received Standard review status.

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On 12 July 2011, the Medicines Patent Pool (MPP) and Gilead announced an agreement for Gilead to license patents for tenofovir (TDF), emtricitabine (FTC), elvitegravir (EVG), cobisistat (COBI) and a four drug combination of these drugs. KEI’s initial comments on the agreement are available here. Continue Reading →

After ten years of deliberations, the 19th session (18-22 July 2011) of the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC/GRTKF) submitted a Decision for approval to the WIPO General Assembly (26 September-5 October 2011) that could pave the way for the General Assembly in 2012 to convene a Diplomatic Conference on an international legal instrument(s) for the protection of genetic resources, traditional knowledge and traditional cultural expressions (TCEs).

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L’OMPI sur la voie d’un instrument international pour la protection des ressources génétiques, des savoirs traditionnels et du folklore.

21.07.11

Eugenia Olliaro (KEI)

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KEI comment on the Medicines Patent Pool license with Gilead
July 12, 2011

FYI: James Love (Tuesday: +44.785.543.6510, james.love@keionline.org). Thiru Balasubramaniam (thiru@keionline.org) or Krista Cox (krista.cox@keionline.org, +1.202.332.2670).

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BRICS Health Ministers’ Meeting
Beijing Declaration
July 11, 2011

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Doha +10

On 14 November 2001, at its Ministerial in Doha, Qatar, the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS Agreement and public health. Exactly 10 years to the date, Knowledge Ecology International (KEI) and the South Centre have are co-hosting a side event at WIPO to discuss the following questions:

How have WTO members implemented paragraphs 4, 6 and 7 of the Doha Declaration? What changes are needed to achieve access to medicine for all?
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Last week I attended the seventh round of negotiations for the Trans-Pacific Partnership Agreement (TPPA) that took place in Ho Chi Minh City, Vietnam. I was able to meet negotiators from all nine negotiating parties and was able to discuss our concerns regarding the proposed U.S. IP chapter for the TPPA, including, in particular, access to medicines and the right to health. I was also able to distribute the joint civil society comments previously submitted to the U.S. Continue Reading →

In response to the WHO Consultative Expert Working Group on R&D Financing’s (CEWG) calls for submissions, 21 proposals were submitted to the CEWG in June 2011 for consideration by the CEWG at their second meeting (7-8 July 2011).

The general link to the WHO CEWG submissions page can be found here: http://www.who.int/phi/news/cewg_submissions/en/index.html

Reproduced below from the WHO CEWG page are links to all the proposals in the order they appear on the WHO page.

Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG)

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June 24: The current negotiating document on disabilities at the WIPO SCCR is SCCR/22/16. A new version Prov. 1 was passed out this morning. Continue Reading →