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FDA Calendar Updates: POZN, AZN, SNY, CEPH, APPY, CYTR
CEPH
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+3.84%
in
133 days
<> 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 Update: Acusphere (OTC:ACUS), Cephalon (NASDAQ:CEPH)
CEPH
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-3.03%
in
36 days
(closed on 06/30/09)
<> 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 to the FDA fo...
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FDA Calendar Updates: SNTS, CEPH, AZN, DNDN, GILD, NVO
CEPH
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-14.16%
in
49 days
(closed on 05/25/09)
<> 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 112 entries through 4/6/09. The FDA Calendar includes the following information: company name, ticker...
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Updated Clinical Trial and FDA Decision Calendars
CEPH
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-1.19%
in
20 days
(closed on 04/06/09)
<> <> Updated Clinical Trial and FDA Calendars
Below is a summary of updates to the www.BioMedReports.co <wbr> </wbr> m database of 243 entries included in the FDA and Clinical Trial Calendars.
http://biomedreports <wbr> </wbr> .com/fda-calendar.ht <wbr> </wbr> ml
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 104 entries through today. The FDA Calend...
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A New Index of Health Product Innovators
CEPH
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-11.30%
in
71 days
(closed on 03/17/09)
<> 
The accompanying table includes statistics and all 23 companies in the ETF Innovators [ETFI] Global Health Innovators Index of companies with market caps over $250M which received FDA approval in the past 12 months for an original new drug product or medical device.
The index includes companies which get approvals for drugs or biological agents classified as new chemical entities (i.e. excluding all new formulations of existing drugs, generic drugs, and label extensions for existing products). Also, companies whi...
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From the Blogosphere
Festival of Stocks #166
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This week we have the honor of hosting the 166th edition of the Festival of Stocks. According to the festival’s original sponsor, ValueInvestingNews, “The Festival of Stocks is a blog carnival dedicated to highlighting bloggers’ best articles on stock market related topics. This will include research and commentary on specific stocks, industry analysis, ETFs, REITs, stock derivatives, and other related topics.” This is the eighth time ModernGraham has hosted the festival, and we are looking forward to hosting it again in the future. <>Before I get to this week’s submissions from so<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>< />< /><>< /><><>< /><>< />< />...
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Cephalon's Upside and Downside
<>Cephalon (CEPH) specializes in bio-pharmaceuticals that target central nervous system (CNS) disorders, pain treatments, and oncology (cancer). The star product over the past few years has been Provigil, a treatment for sleep disorders, that has accounted for about half of sales. Other significant drugs in the portfolio are Fentora and Actiq (the former a replacement for the latter), which account for nearly 25% of sales. Fentora and Actiq are designed to treat cancer-related pain. The final meaningful drug is Treanda, a treatment for leukemia and lymphoma, although Cephalon also has numerou...
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King Beats, but Earnings Down – Analyst Blog
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King Pharmaceuticals, Inc. (KG) reported third quarter earnings of 29 cents per share, beating the Zacks Consensus Estimate by 2 cents. Despite revenues increasing 19.3% from the year-ago period, earnings declined 25.6% from the year-ago quarter mainly due to higher operating expenses.
Total revenues came in at $463.3 million. The primary growth drivers were the Animal Health business, which came as a part of the Alpharma acquisition and an increase in sales of auto-injectors in the Meridian business.
King’s branded pharmaceuticals segment posted revenues of $283 million, down 6.3% from the p< />< /><><><><>< />< /><>< />< />< />< />< />< />< />< />< />< /><><>< /><>< /><>< /><>< /><>< /><>< /><>< /><><>< /><>< /><>< />< />...
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Earnings highlights: Nike, Walgreen, Jabil Circuit, Gannett, Darden ...
Who Will Buy Spectrum Pharmacueticals?
<>There seems to be a lot of speculation on the chances of Spectrum Pharma (SPPI) being acquired over the coming months. I personally don't think it will happen, but there are a few companies that could be interested. Bayer (BYERF.PK) will always be mentioned because of the fact they sell Zevalin in Europe, but Bayer did just divest two oncology drugs to Genzyme (GENZ), Fludara and Leukine, which makes me think that oncology is not where they want to focus their company. Allergan (AGN) should also be mentioned because of their partnership of bladder cancer drug EOquin with Spectrum, the drug...
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