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FDA Calendar Updates: MELA, PGNX, VPHM, WYE
VPHM
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+4.56%
in
116 days
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 288 entries as of 8/5/09. 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, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage cli...
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A New Global Healthcare Composite Index
VPHM
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-41.80%
in
204 days
(closed on 08/05/09)
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The accompanying table [click to enlarge] presents the top five rated companies with market caps of at least $100M from each of the eight new ETF Innovators healthcare indexes, including a database exceeding 500 companies worldwide. The Healthcare Composite Index is a dynamic, semi-active index with quarterly rebalancing which consists of the 40 top-rated companies on an equal weight basis from each of the eight global healthcare indexes listed below and represents an alternative strategy to existing health composite ETF...
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A New Index of Health Product Innovators
VPHM
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-6.57%
in
8 days
(closed on 01/13/09)
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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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FDA Calendar: A Weekly Update
VPHM
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+15.13%
in
30 days
(closed on 01/05/09)
<> 
The accompanying table [click to enlarge] presents an updated calendar of 73 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Catalyst Index. Below is a summary of the FDA action over the past week.
1.) ViroPharma (VPHM) – Filed a sBLA on 12/1/08 to expand use of Cinryze C1 Inhibitor (human) as a treatment for acute attacks of hereditary angioedema [HAE], which is already FDA approved for regular use in the prevention of angioedema attacks in adolescent and adult patients with HAE. Standa< />< />< />< /><>< />< />< />< />< />< />< />< /><>< />< />< />< /><>...
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ETFI Health Innovators Index: Does R&D Lead to Higher Stock Prices?
VPHM
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+7.69%
in
23 days
(closed on 12/05/08)
<> 
<> The accompanying table includes statistics and the top five rated companies in the ETFI Global Health Innovators Index of companies with market caps over $100M which received FDA approval in the trailing 12-month period for either an original new drug or medical device product. The index includes companies which get approvals for drugs or biological agents classified as new chemical entities (i.e. excluding reformulations of existing drugs, generic drugs, and label extensions for existing produc...
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From the Blogosphere
Promising Year Ahead for Optimer Pharma
Optimer Pharmaceuticals (OPTR) recently announced results from the phase III clinical study of fidaxomicin in patients with Clostridium difficile-associated diarrhea ((CDAD)) at the Digestive Disease Week 2009 conference in Chicago.  <>The data presented dealt with patient risk factors related to recurrence of CDAD following treatment. These risk factors include serum albumin levels, white blood cell ((WBC)) count and temperature, and non-BI (NAP1/027) strains. The data showed that overall, fidaxomicin demonstrated a lower recurrence rate compared to oral vancomycin (Vancocin ((R)), the only ...
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Trading FDA Decisions: 14 Extreme Trades
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Below is a summary of companies from the BioMedReports.com FDA Decision Date Calendar which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent.
Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat ...
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Closing Bell: Markets end nearly flat ahead of financial and stimulus plans; BAC, CSCO, GE, TSCM, VPHM
Filed under: Earnings reports, Cisco Systems (CSCO), General Electric (GE), Market matters, Bank of America (BAC), Financial Crisis  It was hard to get a good a gut feel for what the market was doing today, regardless of the closing bell levels. The day was held up because Tim Geithner delayed by a day the Treasury's bank and financial rescue package. But Wall Street took everyone's word at face value that there was only a one-day delay.
Here are the unofficial closing bell levels:
DJIA: 8,270.87 -9.72 -0.12%
NASDAQ: 1,591.56 -0.15 -0.01%
S&P 500: 869.89 +1.29 +0.15%
<>Top Analyst...
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Don't be a sheep -- beware of biotech (VPHM)
Filed under: Major movement  As an investor, I hate crowds. If a stock or sector that I like attracts a crowd, I know it is time to leave. As they say, the sheep are usually the buyers at the top.
Now, we need sheep to help drive prices of our holdings higher, but at some point it is time to jettison. Nothing goes up forever, and the best signal I have found over the years is to sell when the sheep are buying. This year the sheep are being told to buy the biotechnology sector. <>That advice may be a bit late in coming. 2008 was a disastrous year, but biotechnology did very well. It is that perfor...
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Don't be a sheep -- beware of biotech (VPHM)
Filed under: Major movement As an investor, I hate crowds. If a stock or sector that I like attracts a crowd, I know it is time to leave. As they say, the sheep are usually the buyers at the top. Now, we need sheep to help drive prices of our holdings higher, but at some point it is time to jettison. Nothing goes up forever, and the best signal I have found over the years is to sell when the sheep are buying. This year the sheep are being told to buy the biotechnology sector. <>That advice may be a bit late in coming. 2008 was a disastrous year, but biotechnology did very well. It is that perfor...
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