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Orphan Drugs: FDA Advisory Committee Meetings (January – February 2014)

January 8, 2014

Biotechnology stock movements are affected at various phases of the FDA’s drug approval process. Big stock moves, either up or down, are associated with several catalysts :

•    Releases of trial data
•    Briefing documents prior to Advisory Committee meetings (AdComs)
•    AdComs themselves
•    Prescription Drug User Fee Act (PDUFA) dates.

The following chart identifies upcoming FDA Advisory Committee Meetings for the first two months of 2014.

FDA Advisory Committee Meetings (January – February 2014)

Generic          Name Trade          Name Sponsor Indication 2014    AdCom    Date
Droxidopa Northera Chelsea     Therapeutics Symptomatic Neurogenic Orthostatic Hypotension For Patients With Primary Autonomic Failure 01/14/14


Please note the links for the following 2 chart columns above :

1) “Indication” Column Link = Is the FDA Orphan Drug Product Designation Database Link

2) “2013 AdCom Date” = Is the FDA Advisory Committee Meeting Information.

Cellular, Tissue, and Gene Therapies Advisory Committee Meeting: 02/25–02/26/14

The Committee will discuss the following topics :

•   Oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment infertility

•   Guidance documents issued from Office of Cellular, Tissue, & Gene Therapies, Center for Biologics Evaluation and Research (CBER), FDA

•   Considerations for design of early-phase clinical trials of cellular & gene therapy products.

Please Note: FDA Official Logo from FDA website.

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