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FDA, Clinical Trial Calendar Updates: Acorda, Alkermes, GTx
ALKS
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+14.82%
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213 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%
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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%
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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
Good News for Alkermes’ Pipeline – Analyst Blog
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Recently, Alkermes Inc. (ALKS) announced that its drug Vivitrol, which is indicated for the treatment of alcohol dependence, also helped opioid addicts stay away from drugs. Data from the six-month late-stage trial (n=250) demonstrated that subjects injected with Vivitrol (naltrexone for extended-release injectable suspension) once a month were more likely to pass a urine test compared to recipients of a placebo injection. Furthermore, subjects reported a lower craving for drugs, and half the subjects came clean in at least 90% of their drug tests.
The subjects were addicted to opioid dr...
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Big Pharma & Biotech – Industry Outlook
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The pharmaceutical industry has witnessed major changes in 2009. Performance has been affected by factors like sluggish prescription trends, intensifying generic competition and limited phase III catalysts. The next five years are expected to reflect a significant imbalance between new product introductions and patent losses.
According to IMS Health (RX), this is the main reason why global pharmaceutical market growth will be restricted to the mid-single digits through 2013. Over the next five years, products that currently generate about $137 billion in sales are expected to face generic co...
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Big Pharma & Biotech – Zacks Analyst Interviews
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The pharmaceutical industry has witnessed major changes in 2009. Performance has been affected by factors like sluggish prescription trends, intensifying generic competition and limited phase III catalysts. The next five years are expected to reflect a significant imbalance between new product introductions and patent losses.
According to IMS Health (RX), this is the main reason why global pharmaceutical market growth will be restricted to the mid-single digits through 2013. Over the next five years, products that currently generate about $137 billion in sales are expected to face generic co...
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Alkermes Moves to Loss but Beats – Analyst Blog
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Alkermes, Inc. (ALKS) reported a second quarter fiscal 2010 net loss of 5 cents per share, compared with a profit of 2 cents in the year-ago period. The Zacks Consensus Estimate was a loss of 10 cents.
Revenues in the quarter increased 1.9 % to $48.2 million from $47.3 million in the year-ago quarter. The increase was driven by manufacturing and royalty revenues from Risperdal Consta.
Total manufacturing revenues for the quarter came in at $32.8 million as against $33 million in the year-ago quarter. Manufacturing revenues for the quarter included $31.9 million related to Risperdal Consta,<><>< />< />< />< />< />< />< />< />< />< />< />< />< />< />< /><>< /><>< /><>< /><><>< /><>< /><>< />< />...
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Big Pharma and Biotech – Industry Outlook
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The pharmaceutical industry has witnessed major changes in 2009. Performance has been affected by factors like sluggish prescription trends, intensifying generic competition and limited phase III catalysts. The next five years are expected to reflect a significant imbalance between new product introductions and patent losses.
According to IMS Health (RX), this is the main reason why global pharmaceutical market growth will be restricted to the mid-single digits through 2013. Over the next five years, products that currently generate about $137 billion in sales are expected to face generic co...
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