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FDA New drug approvals for 2011, through June 6
This is a report from the FDA on 2011 new molecular entities (NMEs) approvals, through June 6, 2011. The total number of FDA approvals during that same period was 150. So far, 16 NMEs have been approved in five months, a sharp increase in approvals over the same period 2010.
6 NMEs NDAs were considered priorities
8 NDAs that were considered standard approvals
2 BLA (biologic products) that were not classified.
- NMEs were 10.7 percent of all approvals.
- The NME priority NDAs were 4 percent of FDA approvals.
Senator Sanders introduces two medical innovation prize bills in U.S. Senate to de-link R&D costs from drug prices
On Thursday, May 26, 2011, Senator Bernie Sanders (I-VT) introduced two bills in the United States Senate that would de-link R&D costs from drug prices. The bill names and numbers are as follows:
Letter to the 129th WHO Executive Board on conflicts of interest, WHO reform and the future of financing
24 May 2011
NGO letter on Conflicts of Interest, Future Financing, Reform and governance of the WHO.
Dear Members of the Executive Board,
SCP 16: Summary by the Chair
WIPO
World Intellectual Property OrganizationSCP/16/8 PROV.
ORIGINAL: ENGLISH
DATE: MAY 20, 2011Standing Committee on the Law of Patents
Sixteenth Session
Geneva, May 16 to 20, 2011SUMMARY BY THE CHAIR
Agenda Item 1: Opening of the session
1. The sixteenth of the Standing Committee on the Law of Patents (SCP) was opened by Mr. James Pooley, Deputy Director General, who welcomed the participants. Mr. Philippe Baechtold (WIPO) acted as Secretary.
Continue ReadingUSPTO statement at WIPO side event on Medicines Patent Pool
This is the statement that was delivered by Karin L. Ferriter (from USPTO and USTR), at a UNITAID side event on the Medicines Patent Pool, during a break of the WIPO Standing Committee on the Law of Patents.
Statement on Medicines Patent Pool Side EventNGO Statement on WHO governance and the Management of Conflicts of Interest and the Future of Financing for WHO
NGO Statement on WHO governance and the Management of Conflicts of Interest and the Future of Financing for WHO.
May 18, 2011
We write to express our concerns about governance of the World Health Organization (WHO) and other public health bodies, as regards the management of conflicts of interest.
SCP16: Slide presentations of Professor Carlos Correa, Judit Rius Sanjuan and James Love at KEI briefing on Patents and Health
On 17 May 2011, Knowledge Ecology International (KEI) organized a Briefing on Patents and Health at WIPO’s 16h session of the Standing Committee on Patents (SCP). Continue Reading
WIPO patent committee discusses Exception and Limitations to Patent Rights
The World Intellectual Property Organization (WIPO) has convened the 16th session of the WIPO Standing Committee on the Law of Patents (SCP). The SCP elected Albert Tramposch, Administrator for Policy and External Affairs, USPTO as Chair.
Save the Date-17 May 2011-KEI @ WIPO Standing Committee on the Law of Patents: Patents and Health
Knowledge Ecology International: Patents and HealthDATE: Tuesday, 17 May 2011
TIME: 13:30-15h00
VENUE: Room B at the WIPO Main Building