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       Sector: Healthcare  >  Industry: Biotechnology & Drugs
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Trading FDA Decisions: CYPB Soars, A Trio of Buys Graphic_rating_buy AMAG
Mikerun
73%
Trading FDA Decisions: CYPB Soars, A Trio of Buys
 
After the market close today, Cypress Bioscience (CYPB) and Forest Labs (FRX) received FDA approval for Savella (milnacipran) in the treatment of fibromyalgia, almost exactly three months after the original PDUFA date of 10/18/08. Shares of CYPB are soaring into double digits (up over 50%) while FRX is up 10% in after hours trading at just after 6 pm ET.
 
<> Meanwhile, Schering Plough (SGP) was not as fortunate, as the company received a complete response letter for schizophrenia drug Saphris (asenapine). Howe...
By  Mike Havrilla   (+1.04%  risk: conservative)  01/14/09 Comment


Buyout Binge Begins for Bio-Pharma, Diagnostics Graphic_rating_buy AMAG
Mikerun
73%

Buyout Binge Begins for Bio-Pharma, Diagnostics

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<> With news late Friday that Roche (RHHBY) is prepared to up its bid for complete control of Genentech (DNA) to $95 from a previous offer of $89 per share and a $41M ($1.50 per share) all-stock takeover offer by Sequenom (SQNM) for EXACT Sciences (EXAS); 2009 is off to a strong start for M&A activity in the bio-pharma and diagnostic space.

Larger and well funded bio-pharma and diagnostic companies are opportunistically looking to expand their product offerings, pipeline prospects, patent portfolios, ...
By  Mike Havrilla   (+1.04%  risk: conservative)  01/10/09 Comment


Trading FDA Decisions: Buying AMAG Graphic_rating_buy AMAG
Mikerun
73%

Trading FDA Decisions: Buying AMAG

<> With shares of AMAG Pharma (AMAG) declining by about 11% in the past five days and after listening to the conference call from late December again, I am adding to my long position in the Company on the potential for FDA approval of Feraheme (ferumoxytol) during 1Q09.

The complete response letter from the FDA in late December outlined the following three outstanding issues before approval could be granted:

1.) data to clarify a specific chemistry, manufacturing and controls (CMC) question

2.) resolution of the deficienc...
By  Mike Havrilla   (+1.04%  risk: conservative)  01/09/09 Comment


Trading FDA Decisions: Buying AMAG Graphic_rating_buy AMAG
Mikerun
73%

Trading FDA Decisions: Buying AMAG

<> With shares of AMAG Pharma (AMAG) declining by about 11% in the past five days and after listening to the conference call from late December again, I am adding to my long position in the Company on the potential for FDA approval of Feraheme (ferumoxytol) during 1Q09.

The complete response letter from the FDA in late December outlined the following three outstanding issues before approval could be granted:

1.) data to clarify a specific chemistry, manufacturing and controls (CMC) question

2.) resolution of the deficienc...
By  Mike Havrilla   (+1.04%  risk: conservative)  01/08/09 Comment


My UpDown Virtual Investing Portfolio Graphic_rating_buy AMAG
Mikerun
73%

My UpDown Virtual Investing Portfolio

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Start earning real money with zero risk while improving your trading skills and strategies at the UpDown Virtual Investing website -- just click on the image above or any of the text links to the site in this article to sign up today. My stats and profile are featured in the accompanying table and on my blog site below the last posted entry. I started trading at the UpDown on 11/23/08 with a gain of 32.5% through today -- my profile name on the site is 'ETFinnovators' with a portfolio of long positions and link...
By  Mike Havrilla   (+1.04%  risk: conservative)  01/01/09 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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