FDA Calendar Updates: Auxilium Pharma (NASDAQ:AUXL) Print E-mail
Thursday, 18 June 2009 15:14
Below is a summary of updates to the BioMedReports.com FDA Calendar, 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 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 pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
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H1N1 Flu Has Mutated: Which companies may be able to help? Print E-mail
By Jude Santos & Wire Reports   
Thursday, 18 June 2009 04:17
The World Health Organization is closely monitoring the situation in Japan after three students from the same high school who had not traveled abroad came down with the new H1N1 flu, a senior WHO official said. The new strain of influenza appears to have mutated to become more infectious for humans, the online edition of science magazine Nature reported, referencing research by a team including Professor Yoshihiro Kawaoka of Tokyo University's Institute of Medical Science.
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New FDA Commissioner vows to get tougher in the name of safety Print E-mail
By Jamie Tera & Wire Reports   
Wednesday, 17 June 2009 22:08
Newly minted FDA Commissioner Margaret Hamburg says she will toughen up the agency’s enforcement practices. She wants to take the sprawling bureaucracy and remake it into the key federal agency that protects public health. The agency—responsible to ensure drugs, medical devices and products, some human and animal food products, cosmetics, and other consumer goods are safe to Americans—has been widely faulted for all manner of problems, including that had no permanent commissioner for the majority of former President Bush’s eight-year term.
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The Curse's Cure? Print E-mail
Wednesday, 17 June 2009 19:05
Next to the common cold, menstrual cramping is one of the most common causes of recurrent physical discomfort worldwide. Dysmenorrhea is widespread amongst women of child-bearing age and no currently available treatment for this condition is particularly effective or completely safe. Tylenol, the usual drug of choice, is known to cause liver damage and the FDA has recently sounded an alarm about the doses of Tylenol often used to relieve pain.  Nonsteriodal anti-inflammatory drugs aren’t much safer given their well-known side-effect profile.
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BioMedReports FDA Calendar: Seven New Extreme Trades Print E-mail
Wednesday, 17 June 2009 16:07
Below are companies with market caps under $250 million from the BioMedReports.com FDA Calendar, which have either pending FDA decisions or pending clinical trial results that may have a major impact on each of the underlying stock prices. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports.com. Another approach is to simply buy such companies well ahead of their expected catalyst dates for a possible stock price increase as the date approaches and
trading activity increases.
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BioMedReports FDA Calendar: Seven Laggard Trades Print E-mail
Wednesday, 17 June 2009 15:24
Below are seven companies from the BioMedReports.com FDA Calendar database of over 200 entries, which have pending new drug decision(s) at the FDA combined with a stock price that is below its 200-day moving average (200-DMA). The list includes a balanced mix of two large-caps, two mid-caps, and three small-cap stocks which have been laggards in the overall market rally with looming regulatory catalysts in the form of FDA new drug decisions serving as potential upside catalysts. Data Source: Yahoo! Finance on 6/17/09 during late day trading.
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Obama: "Sweeping Overhaul" of the U.S. financial system needed Print E-mail
By Jude Santos & Wire Reports Comtex/AP   
Wednesday, 17 June 2009 15:16
President Obama today proposed the most sweeping overhaul of the U.S. financial regulatory system in 75 years, seeking to correct a “cascade of mistakes” that toppled major securities firms, froze credit markets and

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destroyed $26.4 trillion in stock market value around the world. The proposal, much of which will be subject to approval by Congress, sets out the biggest overhaul of market rules in more than seven decades, adding an additional layer of regulation for the biggest firms. It would create an agency for monitoring consumer financial products, make the Federal Reserve the overseer of companies deemed too big to fail, and bring hedge and private equity funds under federal scrutiny.
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Molecular Insight Jumps As Market Meets Overhaul Plan With Mixed Reviews Print E-mail
By M.E.Garza   
Wednesday, 17 June 2009 12:15
After the Obama administration unveiled its plans for a major regulatory revamp, stocks settled in to a mixed finish for the day. The plan, which gives increased power to the Federal Reserve and creates a new national regulator for financial firms was met with skepticism from traders, who doubt whether the effort will strike the right balance between curbing the excesses and boosting profits. In the health care sector, stocks were definitely more animated than they were yesterday.
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Next Big Market: Adult Stem Cell Drugs and Therapies Print E-mail
By M.E.Garza   
Wednesday, 17 June 2009 10:25
According to a new report in Fortune Magazine, marketable therapies emerging from work in the (less controversial) adult stem space could be the next multi-billion dollar market. Research on adult stem cells has generated a great deal of excitement. Adult stem cells have already been used successfully with patients: to treat cartilage defects in children; restore vision to patients who were legally blind; relieve systemic lupus, multiple sclerosis, and rheumatoid arthritis; and to serve as an aid in numerous cancer treatments.
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Nephros waiting on three FDA decisions. Print E-mail
By Michael Sklar   
Wednesday, 17 June 2009 03:01
Nephros (OTC: NEPH) Nephros like many other Bio Pharm companies these day's is waiting for an FDA decision, actually they are waiting for three. Currently the FDA has made many investor's in this sector ride through bi polar roller coaster's. One of the major reasons is the appointing of a new FDA director. This is understandable because anytime a new director comes on board their is a transition stage. Day traders might worry ,however, people investing with long positions  are investing because of their belief in the company. Nephros is waiting on decions on the following 3 Class 2  510(k) applications:
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