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BioMedReports FDA Calendar: Swine Flu Trial Set to Begin
GSK
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+6.24%
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112 days
<> Below is a summary of updates to the BioMedReports.com FDA Calendar , which includes a database of 265 entries as of 7/21/09. 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 clinica...
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FDA Calendar Updates: BDSI is Worth the Wait, Zicam Warning
GSK
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+5.62%
in
35 days
(closed on 07/21/09)
<> 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 Calendar Updates: MITI, KERX, GSK, DYAX, ARNA, PGNX
GSK
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+8.41%
in
8 days
(closed on 06/16/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of about 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-s...
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FDA, Clinical Trial Calendar Updates: Weight Loss, Diabetes, and More
GSK
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+6.87%
in
68 days
(closed on 06/08/09)
<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 110 entries through 4/1/09. The FDA Calendar includes the following information: company name, ticker, decision d...
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A 130/30 Pharma Trade
GSK
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+4.33%
in
40 days
(closed on 04/01/09)
By Mike Havrilla on 2/20/09 ETF Innovators The tables at my website link below include 12 U.S. listed companies from the ETF Innovators Global Generic Drug Index along with seven brand drug companies, which are ranked in descending order based on their patent expiration exposure through the end of 2011 as a percentage of total trailing 12-month revenue. <> Investors who are bullish on the generic drug industry may consider implementing a 130/30 pharma trade by shorting any/all...
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From the Blogosphere
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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Santarus Reports Strong Quarter – Analyst Blog
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Santarus, Inc. (SNTS) reported third-quarter earnings of 9 cents per share, surpassing the Zacks Consensus Estimate at a loss of 1 cent and the year-ago loss of 8 cents. Total revenues, consisting of net product sales, promotion revenues, and license and royalty revenues, came in at $39.5 million, up 22% from the year-ago period.<>Product-related revenues, which consist of net product sales and promotion revenues, increased 30% to $38.3 million in the third quarter of 2009. Zegerid net product sales were $31.5 million, up 12%. Total prescriptions increased 6.3% in the reported quarter. Compe...
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Lower Q3 Loss for Human Genome – Analyst Blog
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Human Genome Sciences, Inc. (HGSI) reported third quarter net loss of $49 million or 32 cents per share, in-line with the Zacks Consensus Estimate. The company reported a net loss of $74.2 million or 50 cents in the year ago quarter. The lower net loss for the quarter was primarily attributable to increased revenues from manufacturing and development services and lower operating expenses.
Revenues for the quarter came in at $18.834 million which reflected an increase of 60.6%. Revenues were inclusive of $8.7 million from manufacturing and development services, $8.9 million recognized under...
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Gilead Sciences Combination Therapy (NASDAQ:GILD)
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Gilead Sciences, Inc. (NASDAQ:GILD) in partnership with the GlaxoSmithKline plc (ADR) (NYSE:GSK) today has announced their plans for an international clinical trial to study the combination therapy versus monotherapy in a first-line treatment setting for pulmonary ...
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United Therapeutics Misses – Analyst Blog
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United Therapeutics Corporation (UTHR) reported a net income of 21 cents per share in the third quarter, well below the Zacks Consensus Estimate of 31 cents. The company reported earnings of 22 cents in the year-ago period. Even though revenues increased 29.6% to $97.2 million in the reported quarter, higher operating expenses led to the lower than expected net income.
The increase in revenues was primarily due to the continued increase in the number of patients being prescribed Remodulin and the recent launches of new products, Tyvaso and Adcirca. Net product sales, consisting of Remoduli...
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