What to look for in the new Tufts study on drug development costs. 10 issues.
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:
Research note on oncology drugs, including trial size and orphan drug status
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:
KEI Research Note: Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results
A copy of the research note is also available here as a pdf file: /wp-content/uploads/kei-rn-2014-3.pdf
KEI Research Note 2014:3
Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results
Elizabeth Rajasingh
November 17, 2014
Introduction
Former WTO Director-General, Pascal Lamy, mooted to chair Global Fund’s Equitable Access Initiative
On 14 March 2014, KEI published “Resurrecting the Ghost of Høsbjør Past: Global Fund seeks to establish global framework on tiered pricing enforced by WTO rules” in which we provided an analysis of the Global Fund’s plans to create a global framework for tiered pricing enforced by the rules of the World Trade Organization (WTO). Continue Reading
WIPO patent committee engaged in heated talks on work sharing, limitations & exceptions, client confidentiality
6 November 2014
WIPO patent committee (SCP21): Intervention of KEI on Patents and Health
The following intervention on patents and health was delivered by KEI during the 21st session on WIPO’s Standing Committee on the Law of Patents (SCP). Part 1 was delivered on 4 November 2014 during discussions of the Feasibility Study on the Disclosure of International Nonproprietary Names (INN) in Patent Applications and/or Patents. Part 2 was delivered on 5 November 2014 during general discussions on patents and health.
Statement of Knowledge Ecology International (KEI)
Item 7: Patents and health
Part 1
WIPO patent committee (SCP21): Intervention of Pakistan on Patents and Health
On Wednesday, 5 November 2014, Pakistan delivered the following intervention on patents and health.
Agenda 7 Statement on patents and health
1. General statement
Mr. Chair,
I will make this statement in national capacity,
WIPO Standing Committee on the Law of Patents (SCP 21): Intervention of Pakistan on Opposition Systems
On Tuesday, 5 November 2014, Pakistan delivered the following intervention on opposition systems.
Mr. Chairman,
The agenda item on quality of patents also include another item on “opposition systems” which was not discussed by the Committee. I want to make a small statement on opposition systems.
WIPO patent committee (SCP21) to discuss International Nonproprietary Names and Exceptions and Limitations to Patent Rights
In the words of the International Bureau of the World Intellectual Property Organization (WIPO), the WIPO Standing Committee on the Law of Patents (SCP) was created,
created in 1998 to serve as a forum to discuss issues, facilitate coordination and provide guidance concerning the progressive international development of patent law.
WTO TRIPS Council (October 2014): Statement of India on the Review of the Paragraph 6 system (compulsory licensing for export)
On 28 October 2014, India delivered the following intervention at the WTO TRIPS Council’s annual review of the Paragraph 6 system (designed to facilitate compulsory licensing for export of pharmaceuticals).
In particular, India noted that