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Posts related to ‘FDA’

Can A European Approval of Pixantrone Save Cell Therapeutics? (CTIC)

Posted: May 10, 2012 at 4:14 pm

Cell Therapeutics, Inc. (NASDAQ: CTIC) is about as controversial of a biotech stock as there can be.  It often traded huge volume around drug approval or study news, and shares ...
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VioPharma Runs Into FDA & FTC Troubles Over Staph Drug (VPHM)

Posted: April 10, 2012 at 8:35 am

ViroPharma Incorporated (NASDAQ: VPHM) is getting crushed on news that the Food & Drug Administration has denied the petition filed by ViroPharma on March 17, 2006 related to the FDA's ...
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VIVUS Faces Shareholder Risks After FDA Delay On Obesity Pill (VVUS, ARNA, OREX)

Posted: April 10, 2012 at 7:11 am

VIVUS Inc. (NASDAQ: VVUS) is getting a bit of a haircut this morning on the heels of some news from the Food & Drug Administration which may throw up some ...
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Thoratec Clarifies Recall News (THOR)

Posted: April 4, 2012 at 3:54 pm

There is good news and bad news on Thoratec Corporation (NASDAQ: THOR) today.  The bad news is that it did have a FDA news recall of its HeartMate II® Left Ventricular ...
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How Do You Recall Heart Devices? (THOR)

Posted: April 4, 2012 at 2:55 pm

Thoratec Corporation (NASDAQ: THOR) took it on the chin today after news came out about the Food & Drug Administration recalling the company's HeartMate II as the left ventricular-assist system.  What is interesting ...
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Potential Deathblow for Chelsea (CHTP)

Posted: March 29, 2012 at 9:20 am

Chelsea Therapeutics International Ltd. (NASDAQ: CHTP) is being beaten hard this morning.  News hit that the FDA has now rejected the company's Northera drug to treat low blood pressure for ...
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Diabetes Drug Approved For Europe (AMLN, LLY)

Posted: March 23, 2012 at 8:49 am

Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) and Eli Lilly & Co. (NYSE: LLY) are in the news on the diabetes front.  The companies have announced that the European Commission has now ...
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The Generic Boniva Opportunity (RHHBY, MYL)

Posted: March 19, 2012 at 4:02 pm

The Food and Drug Administration approval of the first generic versions of osteoporosis drug Boniva won't be the end of Roche Holding AG (OTC: RHHBY) for its marketing of Boniva in the ...
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Another Boost For Threshold (THLD)

Posted: March 16, 2012 at 7:59 am

Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) has been one of the top performing stocks of 2012.  Not just in emerging pharma and in biotech, but across the board.  Now we have ...
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Walmart Decides to Cut Sales of Unhealthy Foods

Posted: February 7, 2012 at 6:51 am

Instead of admitting that it has, in the past, sold food with too much sodium, salt and sugar, Walmart (NYSE: WMT) has made a public relations bonanza of its decision ...
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Winners as Pfizer Loses Lipitor Patent (PFE, TEVA, MYL, WPI)

Posted: November 29, 2011 at 11:28 am

Pfizer Inc. (NYSE: PFE) has a big day ahead of it.  While it has been known for years, it is a massive date: Lipitor goes off-patent and will have generic ...
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Why “Sell the News” on Seattle Genetics (SGEN)

Posted: August 22, 2011 at 1:17 pm

There is an old rule of thumb from biotech investors and traders... SELL FDA APPROVALS.  This is very counter-intuitive on the surface but we wanted to explain in more detail ...
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Opinions Vary on Impact of New FDA Cigarette Warning Labels (RAI, LO, PM)

Posted: June 24, 2011 at 11:34 am

If you have seen the graphic images that will go on cigarette packages late in 2011, you might think that the tobacco companies have finally met their match.  The graphic ...
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Beyond Dodd-Frank… Frank-Paul Marijuana Legalization Legislation? (MO, RAI, BUD, TAP, PEP)

Posted: June 22, 2011 at 5:20 pm

If Altria Group Inc. (NYSE: MO), Reynolds American Inc. (NYSE: RAI), Anheuser-Busch InBev (NYSE: BUD), and Molson Coors Brewing Company (NYSE: TAP)  should keep an eye on efforts to legalize ...
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FDA Cigarette Warnings Getting More Harsh Than Europe (MO, RAI, LO, VGR, PFE)

Posted: June 21, 2011 at 3:44 pm

The FDA is about to give some serious warning labels on cigarette labels.  Altria Group Inc. (NYSE: MO), Reynolds American Inc. (NYSE: RAI), Lorillard, Inc. (NYSE: LO)  and Vector Group ...
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