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3 Orphan Drug Companies Face FDA Advisory Committee Meetings Next Week (October 16 – 18, 2012)

October 12, 2012

       The Orphan Druganaut October 10, 2012 Blog Post identifies the 3 orphan drug companies facing FDA Advisory Committee Meetings October 16 – 18, 2012, for their orphan drugs :

1)       October 16, 2016: Gastrointestinal Drugs Advisory Committee Meeting to discuss NPS Pharmaceuticals’ Gattex (Teduglutide) for Short Bowel Syndrome (SBS)

2)       October 17, 2012: Endocrinologic & Metabolic Drugs Advisory Committee Meeting to discuss Aegerion Pharmaceuticals’ Lomitapide for Homozygous Familial Hypercholesterolemia (HoFH)

3)       October 18, 2012: Endocrinologic & Metabolic Drugs Advisory Committee Meeting to discuss Genzyme’s Mipomersen for Homozygous Familial Hypercholesterolemia (HoFH).

       Briefing documents are usually posted just before the meetings. These briefing documents are more important than the actual meeting, because they give investors a picture of what the FDA reviewers are thinking. The advisory committee votes are just a recommendation – it is the FDA who has the final say.

      An October 11, 2012 article from The Motley Fool says that “ …. biotech investors are in for a 3-day treat next week when 3 companies head in front of FDA advisory committees.” The article predicts that all 3 drugs should get through their events with recommendations for approval.

Copyright  © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.

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