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FDA, Clinical Trial Calendar Updates: Acorda, Alkermes, GTx
ALKS
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+4.25%
in
200 days
<> 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 to the FDA for complete r...
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A Calendar of Expected Clinical Trial Results
ALKS
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-24.07%
in
102 days
(closed on 04/23/09)
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The accompanying table [click to enlarge] includes 58 entries of expected clinical trial results in addition to pending FDA applications for new product approvals + a list of companies which will be required to re-submit their applications due to complete response letters from the agency.
See my recent article on 20 emerging healthcare stocks to watch in 2009 for more details on some of the companies included in the accompanying calendar, in addition to the following companies with near-term catalysts in...
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Updated FDA Calendar
ALKS
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+5.25%
in
29 days
(closed on 01/11/09)
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The accompanying table [click to enlarge] includes a weekly update of 71 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Decision Catalyst Index. Since my article last week , the following action has taken place at FDA:
1.) Pain Therapeutics (PTIE) & King Pharma (KG) lost 21% and 7%, respectively, today after receiving a complete response letter from the FDA for their abuse-resistant form of controlled-release oxycodone, which is designed to deter the abuse and diver...
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ALKS is a SELL
ALKS
From the Blogosphere
Alkermes Outlook Remains Bleak
By: Grant Zeng, CFA Alkermes Inc. (ALKS) reported fiscal fourth quarter (ended March 31, 2009) financial results on May 21, 2009.
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A defensive investment: Biotechnology ETFs
Filed under: Mutual funds, Abbott Laboratories (ABT), Genentech Inc (DNA), ETF Investing  One of the buzzwords that is currently in vogue in the investment community is biotechnology. This is a broad-based field that covers technological applications in any biological system, meaning humans, animals, agriculture, and medicines. This is a booming science and the investment field offers many opportunities for wealth accumulation.
<>If you don't want to spend countless hours trying to understand not just financials, but scientific and technical jargon that biotech companies harbor, <>exchange-traded ...
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A Calendar of Expected Clinical Trial Results
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The accompanying table [click to enlarge] includes 58 entries of expected clinical trial results in addition to pending FDA applications for new product approvals + a list of companies which will be required to re-submit their applications due to complete response letters from the agency.
See my recent article on 20 emerging healthcare stocks to watch in 2009 for more details on some of the companies included in the accompanying calendar, in addition to the following companies with near-term catalysts in the form of clinical trial results:
Sequenom (SQNM) is set for a busy month after its $41...
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Analyst upgrades, downgrades and initiations: ALKS, CS, EBAY, AMZN, EXPE, FDX ...
Updated FDA Calendar: Buying Cypress Bioscience
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The accompanying table [click to enlarge] includes a weekly update of 71 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Decision Catalyst Index. Since my article last week, the following action has taken place at FDA:
1.) Pain Therapeutics (PTIE) & King Pharma (KG) lost 21% and 7%, respectively, today after receiving a complete response letter from the FDA for their abuse-resistant form of controlled-release oxycodone, which is designed to deter the abuse and diversion of the blockbuster pain drug OxyContin sold by privately-held Purdue Pharma.
While deta...
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