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BioMed News Bytes: Aldagen, Dyax, HGSI
HGSI
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+50.35%
in
12 days
The <font> BioMedReports.com FDA Calendar service </font> includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. <> On 6/8/09, Dyax Corp. (NASDAQ: DYAX) announced today that the FDA accepted the Co...
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FDA Calendar November Stocks: Turkeys or a Happy Thanksgiving?
HGSI
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-6.52%
in
3 days
(closed on 10/28/09)
<> <> On 7/15/09, Cadence Pharma (NASDAQ: CADX) announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the FDA and designated for a priority (six-month) review. The FDA has issued a PDUFA action date for the NDA of 11/13/09 for a possible decision by the Agency. The Company's 505(b)(2) NDA for Acetavance includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and ...
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New Indexes to Track Healthcare Trends and More
HGSI
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+31.04%
in
82 days
(closed on 10/25/09)
Below are links and descriptions for 23 new stock indexes I have created, revised, and tracked over the past few years which are now featured at a new website called Investars YOU. The new site includes automated index tracking, allows investors to create custom stock portfolios based on their individual preferences, and now features free access to all of the component stocks in each of my indexes. Some of the top performing stocks from my healthcare indexes on a year-to-date basis are highlighted below.
Cosmetic & Restorative Medicine Index: Allergan (NYSE:AGN) (+38%) <> The <> ...
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FDA Calendar Updates: BVX, HEB, HGSI, ONXX, SGP
HGSI
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+6.62%
in
13 days
(closed on 08/04/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 273 entries as of 7/22/09. 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 <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 pendin...
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FDA Calendar Updates: DDSS, HGSI, OREX, SPPI, TRIB
HGSI
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-11.88%
in
3 hours
(closed on 07/20/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 263 entries as of 7/20/09. 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 <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 pendin...
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From the Blogosphere
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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Innovative Drug Companies Headline the Gainers
For all the debate about possible reform to the U.S. medical system, it is easy to forget that the majority of major innovations in drugs and medical devices come from America. It is worth remembering that even with all the problems troubling the health care system, innovation continues to be a bright spot. Three of the biggest gains among individual stocks on Monday were from U.S. companies in the pharmaceutical sector largely because of this sort of innovation.. <> The biggest winner in today’s action are investors in Human Genome Sciences (HGSI) which is up more than 30% in afternoon t...
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FDA Panel Seeks ABthrax Data – Analyst Blog
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A panel of experts of the US Food and Drug Administration (FDA) has recently asked for additional data to judge the efficacy of Human Genome Sciences Inc.’s (HGSI) anthrax infection treatment ABthrax (raxibacumab) compared to existing anti-bacterial drugs.
The panel of experts voted 17 to 6, with one abstention, that the company should submit more evidence on whether adding ABthrax to older drugs is beneficial for anthrax treatment.
Data from studies had revealed that antibiotic medicines used alone were highly effective against anthrax, thereby raising questions about the added benefit...
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Options Update: Human Genome November volatility at 248 into data
Notable Analyst Rating Change 10/29: FITB, AET, GNW, HGSI, WYN Upgraded; GT, GCI, ATVI, FSLR, KSP Downgraded
UPGRADES:Robert Baird upgraded Fifth Third Bancorp (NASDAQ: FITB) from Neutral to Outperform with an $11 price target. JP Morgan upgrades Aetna (NYSE: AET) from Neutral to Overweight.Bank of America upgrades Genworth Financial (NYSE: GNW) from Neutral to Buy. Price target lowered by $1 to $13. JP Morgan also upgraded Human Genome (NASDAQ: HGSI) to Overweight from Neutral, and raised their price target tp $25 from $14.FBR Research upgrades Wyndham Worldwide (NYSE: WYN) to Outperform. Price target $23. For daily real-time Upgrades go to http://www.streetinsider.com/UpgradesDOWNGRADES:Bank of ...
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About Human Genome Sciences Inc
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Human Genome
