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AMAG Analysis & Videos »
AMAG: Bull or Bear?
FDA Calendar Updates: Feraheme Approval for AMAG
AMAG
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-18.02%
in
132 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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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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Trading FDA Decisions: CYPB Soars, A Trio of Buys
AMAG
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-21.32%
in
57 days
(closed on 03/12/09)
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...
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Buyout Binge Begins for Bio-Pharma, Diagnostics
AMAG
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+1.81%
in
4 days
(closed on 01/14/09)
<> 
<>
<> 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, ...
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Trading FDA Decisions: Buying AMAG
AMAG
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-0.47%
in
19 hours
(closed on 01/10/09)
<> 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...
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Trading FDA Decisions: Buying AMAG
AMAG
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+0.00%
in
21 hours
(closed on 01/09/09)
<> 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...
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My UpDown Virtual Investing Portfolio
AMAG
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-10.40%
in
7 days
(closed on 01/08/09)
<> 
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...
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My UpDown Virtual Investing Portfolio
AMAG
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+0.00%
in
1 minute
(closed on 01/01/09)
<>
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...
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Five Healthcare Stocks for a Happy New Year
AMAG
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+14.57%
in
8 days
(closed on 01/01/09)
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<>
The accompanying table includes a basket of five small-cap stocks chosen from the ETF Innovators [ETFI] new healthcare indexes. The five companies are trading above their 50-day moving averages with expected upside catalyst(s) in the next six months or less.
AMAG Pharma (AMAG) announced last evening that the FDA issued another complete response for its iron deficiency anemia drug ferumoxytol (Feraheme). More details are expected today at 8:30 AM [ET] when AMAG will hold a conference call , but the Company...
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FDA Calendar: AMAG Pharma is a Buy
AMAG
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-4.69%
in
3 days
(closed on 12/23/08)
<> 
The accompanying table [click to enlarge] includes an updated FDA calendar of 69 expected decision dates included in the ETF Innovators [ETFI] New Drug Regulatory Catalyst Index, with seven companies listed in red with overdue decisions. Since my last update , the following FDA action has occurred:
1.) Amgen (AMGN) filed a BLA for bone drug denosumab in the following two indications: the treatment + prevention of osteoporosis in post-menopausal women and the treatment + prevention of bone loss in patient...
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UpDown Virtual Investing: Earn Real Money with Zero Risk
AMAG
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-3.92%
in
1 day
(closed on 12/20/08)
<> 
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 26 days ago with a gain of about 27% through today -- my profile name on the site is 'ETFinnovators' with a portfolio of long pos...
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An A-List of Stock Buys: Altria and AMAG Pharma
AMAG
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+5.20%
in
4 days
(closed on 12/19/08)
<> On my stock A-List of stock buys today are defensive picks from tobacco and healthcare, including Altria (MO) and AMAG Pharma (AMAG).
Altria was well on its way to 16 bucks today on an analyst upgrade until the Supreme Court ruled that tobacco companies could be sued for deceptive marketing practices for light cigarettes. Altria believes the litigation is manageable and the Company noted that the ruling today simply allows the lawsuits to proceed and does not reflect a decision of liability against MO in the cases.
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