FDA

FDA Approves Medtronic (MDT) Diabetes Management System

Posted on 03/17/10 at 9:17am
Medtronic, Inc. (NYSE: MDT) announced on Wednesday that the company's MiniMed Paradigm REAL-Time Revel System diabetes management system was approved by the U.S. Food and Drug Administration.
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Boston Scientific Corporation (BSX) Options Active On Positive FDA Data

Posted on 03/16/10 at 2:10pm
Boston Scientific Corporation (NYSE: BSX) shares have been in play as of late, fueled by take over and FDA chatter. Boston Scientific Corporation (NYSE: BSX) is in play this afternoon rising 5% on heavy volume (100mil vs 25mil avg).
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Boston Scientific Corp. Halts Sale Of ICDs (BSX)

Posted on 03/15/10 at 4:13pm
Boston Scientific Corp. (NYSE: BSX) has stopped the shipment of its implantable cardioverter defibrillators. The company is also in the process of retrieving inventory of its ICDs. The medical device manufacturer said it “has determined that some manufacturing process changes were not submitted for approval to the Food and Drug Administration.
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Amylin Shooting Higher

Posted on 03/15/10 at 10:08am
Amylin Pharmaceuticals (NASDAQ: AMLN) is shooting higher today, currently up 8.84% to $22.05, after the FDA ruled on their long-acting diabetes drug, Byetta. The FDA did deny Amylin’s application for the drug, but it was not due to quality control or clinical trials; they rejected the drug because of packaging problems and risk-management issues.
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Medtronic (MDT) Gets FDA Approval For Epilepsy Treatment

Posted on 03/12/10 at 7:45pm
The Associated Press reported on Friday that a panel at the Food and Drug Administration approved a brain stimulator made by Medtronic Inc. (NYSE: MDT) for the treatment of epilepsy.
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Pfizer Hits A Speed Bump Today (PFE)

Posted on 03/12/10 at 3:44pm
Shares of Pfizer (NYSE: PFE) tumbled today after the company announced disappointing clinical news for two oncology products, Sutent and figitumumab. Phase III studies of Sutent demonstrated that it was not effective in treating breast cancer.
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Medtronic’s Epilepsy Device Fails FDA Test (MDT, CYBX)

Posted on 03/10/10 at 9:26pm
Medtronic’s (NYSE: MDT) new nerve stimulating implant has failed to meet its study goal. The device is currently used to treat various movement disorders. Medtronic has sought FDA approval for the use of the implant for treating epilepsy. In a document, FDA has said that the implant failed to ensure reduction in the incidence of seizures.
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Thomas Weisel Partners More Than Double InterMune (ITMN) Price Target To $55

Posted on 03/10/10 at 9:15am
Thomas Weisel Partners analyst Stephen Willey maintained his Overweight rating for shares of InterMune, Inc. (Nasdaq: ITMN) and raised the price target from $26 to $55.
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InterMune (ITMN) Shares Jump 63% After FDA Announcement

Posted on 03/09/10 at 6:56pm
Shares of InterMune, Inc. (Nasdaq: ITMN) surged more than 60% after a panel at the Food and Drug Administration recommended the company's Esbriet for treatment of idiopathic pulmonary fibrosis. IPF is a rare and deadly lung disease with no existing FDA approved treatments, which affects nearly 200,000 people in the United States and Europe.
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Five Biotech ETFs, Which One Is Worth A Look?

Posted on 03/09/10 at 6:33pm
Believe it or not there are actually more biotech ETFs available to U.S. investors than there are ETFs focusing on big pharma companies. The count is five to four, but we could probably live with fewer biotech choices.
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