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FDA Calendar Updates: Feraheme Approval for AMAG
AMAG
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-27.18%
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145 days
<> Below is a summary of updates to the BioMedReports.com FDA Calendar , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical ...
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FDA Calendar Updates: AMAG, PPDI, Takeda
AMAG
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-0.16%
in
22 hours
(closed on 06/30/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-st...
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BioMedReports FDA Calendar: Hot Summer Trades
AMAG
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+8.50%
in
13 days
(closed on 06/29/09)
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FDA, Clinical Trial Calendar Updates: AMAG, IMMU
AMAG
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-8.32%
in
35 days
(closed on 06/16/09)
<> Below is a summary of updates to the <font> BioMedReports.com </font> database of over 200 entries included in the <font> FDA and Clinical Trial Calendars </font> . The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions...
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Three Oversold Healthcare Catalyst Stocks
AMAG
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+114.96%
in
61 days
(closed on 05/12/09)
Three Oversold Healthcare Catalyst Stocks With the S&P 500 SPDR ETF (SPY) trading about 8% below its 50-day moving average (DMA), I went in search of oversold healthcare stocks trading at least 16% below their 50 DMA which have potential catalysts within the next six months that may provide some very nice returns. <> The Healthcare Sector SPDR (XLV) is trading about 12% below its 50 DMA amidst concerns of sweeping healthcare reform that would threaten the profits of health insurers, managed care companies, big pharma, and biotechs – although such concerns may be ove<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>...
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From the Blogosphere
Trading Radar for 10/29: Exxon (XOM), Motorola (MOT), Waste Management (WM) Report
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The Trading Radar highlights key earnings and economic announcements for tomorrow's trading session:<u>Before Market Opens:</u>Economics:8:30am ET<ul<li>GDP - Street Sees 3.2%<>Initial Claims - Street Sees 525KEarnings:ABB (NYSE: ABB) – consensus EPS $0.30Acme United (NYSE: ACU) – consensus EPS $0.39Aetna Inc. (NASDAQ: AET) – consensus EPS $0.66AGL Resource (NYSE: AGL) – consensus EPS $0.23Agree Realty (NYSE: ADC) – consensus EPS $0.69Airgas (NYSE: ARG) – consensus EPS $0.67Airvana (NASDAQ: AIRV) – consensus EPS $0.22Alexander & Baldwin (NASDAQ: ALEX) – consensus EPS $0.28Allegheny Energy, I...
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Rockwell Medical's Potential for Exponential Gains
Rockwell Medical (NASDAQ:RMTI) has the potential for significant stock price gains by 2012 based on the enhanced earnings power of at least $4/share at that time for its lead clinical compound Soluble Ferric Pyrophosphate [SFP] with just a 20% share of the estimated $600 million U.S. market for iron replacements in 2012. The stock appreciation potential for RMTI is similar to the exponential gains experienced by AMAG Pharma (NASDAQ:AMAG) from the earlier part of this decade, culminating in approval of its IV iron replacement drug Feraheme earlier this year.
<><>However, Rockwell is unique becaus...
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AMAG Pharmaceuticals' Feraheme: The Next Billion Dollar Drug
On June 30, 2009, the FDA approved Feraheme for the treatment of anemia in chronic kidney disease (CKD), both in pre-dialysis patients and those undergoing dialysis. Feraheme, sold by AMAG Pharmaceuticals (AMAG), received a clean label without any black box warnings. Now that Feraheme has been approved, the key question for investors is what the market opportunity is and how quickly it will be achieved. Background on Feraheme
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Expect FDA Approval of AMAG Pharmaceutical's Feraheme
<font>By June 29, 2009, we expect the U.S. Food and Drug Administration ((FDA)) to decide on the </font>marketing application of AMAG Pharmaceuticals, Inc.’s (AMAG) Feraheme (formerly known as Ferumoxytol), designed for the treatment of iron deficiency in anemia patients with chronic kidney disease ((CKD)), including dialysis dependent and non-dialysis dependent CKD patients. <><><font>Anemia is a condition of abnormally low levels of red blood cells (RBCs) in the blood and hemoglobin. Hemoglobin is a protein present in RBCs that is responsible for transporting oxygen to the b...
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AMAG Pharma: Strong Prospects for Feraheme's Success
After receiving two complete-response letters from the FDA in October and December of last year, AMAG Pharmaceutical's (AMAG) day of reckoning is quickly approaching. After most recently being delayed because of manufacturing concerns, AMAG’s PDUFA date for Feraheme, or ferumoxytol, has been re-scheduled for June 29th. The company is seeking approval for ferumoxytol to treat iron deficiency anemia in patients with chronic kidney disease. <>Last month, the FDA informed AMAG that it had satisfactorily addressed their concerns noted during the inspection of their manufacturing facility. Wi...
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About Advanced Magnetics Inc.
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