Month: June 2011

KEI Intervention at UN HLM on HIV: De-Linking R&D costs from drug prices and the sustainability of treatment

Posted on by James Love

un_hlm_panel_3_IMG_2446.JPGThese are the notes from my intervention today at the UN’s High Level Meeting on HIV/AIDS in New York. The persons making statements from the floor were asked to keep their comments to two minutes, so the actual intervention was somewhat shorter. Jamie

2011 High-Level Meeting on
the comprehensive review of the progress achieved in realizing
the Declaration of Commitment on HIV/AIDS and
Continue Reading →

Uncategorized

FDA New drug approvals for 2011, through June 6

Posted on by KEI Staff

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.

    • Continue Reading →

Uncategorized