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       Sector: Healthcare  >  Industry: Biotechnology & Drugs
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A Coiled Spring: Near-Term Catalysts & Oversold Stocks Graphic_rating_buy AMAG
Mikerun
73%

A Coiled Spring: Near-Term Catalysts & Oversold Stocks

<> AMAG Pharma (AMAG) more than doubled on word that the FDA accepted its complete response for a NDA of iron-deficiency anemia drug ferumoxytol in patients with chronic kidney disease and will issue a final ruling before year-end. The news is a major relief for AMAG as no new clinical trials were required and the quick decision deadline before year-end is encouraging for the approval prospects of ferumoxytol.

A trio of companies expect FDA decisions for abuse-resistant pain drugs before year-end, including Pain The...
By  Mike Havrilla   (+1.04%  risk: conservative)  12/03/08 Comment


Full Calendar of FDA Decisions Graphic_rating_buy AMAG
Mikerun
73%

Full FDA Calendar of Decision Dates

<>
The accompanying table [click to enlarge] includes an updated calendar of 73 expected FDA decision dates. Click here for my previous articles and FDA calendars , including several companies with expected decisions before year-end expected to have major stock price impacts, but keep in mind the backlog of delayed decisions that is building means that none of the dates are certain to produce final decisions.
 
<> Genzyme (GENZ) could hear back from the FDA as early as Monday for approval of Myozyme at the 2,000L...
By  Mike Havrilla   (+1.04%  risk: conservative)  11/30/08 Comment


Emerging Biotech & Pharma Index: 36 More Companies Graphic_rating_buy AMAG
Mikerun
73%

Emerging Biotech & Pharma Index: 36 More Cos.

<>
The accompanying table [click to enlarge or download] includes the 36 remaining companies in the ETF Innovators [ETFI] Emerging Bio-Pharma Index with market caps between $150M-$1.5B, which were not included in the previous two articles I wrote about the group – featuring the Top 40 Rated Companies and companies below the $150M market cap cutoff.

However, several of the companies included in the remaining group of 36 have been in the news recently due to FDA related news . Late last week, Ligand Phar...
By  Mike Havrilla   (+1.04%  risk: conservative)  11/23/08 Comment


Full Calendar on Tap for FDA through Year-End Graphic_rating_buy AMAG
Mikerun
73%

Full Calendar on Tap for FDA through Year-End

<>
<>
The accompanying table presents an updated calendar of 30 decision dates which either have deadlines before year-end or represent delays in previously expected decisions in which the FDA has not issued a new date for a final decision.

After the close today, Pain Therapeutics (PTIE) and King Pharma (KG) announced mixed results from a FDA panel review of Remoxy, which is designed to be an abuse-resistant opiate pain drug in response to abuse and diversion issues with drugs such as Purdue Pharma's OxyCont...
By  Mike Havrilla   (+1.04%  risk: conservative)  11/13/08 Comment


Advanced Magnetics Inc. Graphic_rating_buy AMAG
Foto
62%

AMAG Pharmaceuticals' Ferumoxytol meets Phase III clinical trial end point.

<>

On May 31st, AMAG Pharmaceuticals ( NASDAQ: AMAG , Stock Forum ) announced results from a randomized phase III study of Ferumoxytol, an intravenous (IV) iron replacement therapy, in 31 patients with chronic kidney disease (CKD) stages 1-5 with functioning kidney transplants. The primary endpoint was the mean change in hemoglobin from baseline at Day 35.

The following results were obtained (copied from business wire press release at Yahoo.com)

<> <> For the primary endpoint, the mean ...
By  Marian Filo   (-24.55%  risk: aggressive)  07/04/08 Comment



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Discussion Wall + Add  
sudipbanerjee   (+110.44%  risk: conservative)
Upcoming FDA Decision on June 29th on approval of a.. - The upcoming FDA Decision date on JUNE 29th (Monday) for AMAG's Feraheme for iron deficiency in Anemia patients is a critical event for the company. I...
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