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FDA Meetings And Latest On Biotech Front

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Published: Tuesday, 11 Sep 2007 | 10:59 AM ET

So, I thought I'd be spending today monitoring the webcast of the FDA Advisory Committees that are meeting to decide whether doctors should use less of the anemia drugs from Amgen and Johnson & Johnson to treat kidney dialysis patients. And while I will stay on top of it for the vote later today, my hands are suddenly full with a flurry of breaking news items in biotech.

ImClone Systems: The stock hit a new intra-day high on results of a large, late-stage clinical trial showing lung cancer patients lived longer. The actual duration of the survival benefit will be unveiled at a future scientific conference (a venue where investors and doctors believe gives the data a certain level of street cred), but that isn't stopping investors from buying into the news. If the data are robust they could hurt sales of Genentech's lung cancer drugs Avastin and Tarceva which it shares with OSI Pharmaceuticals. ImClone shares Erbitux with Bristol-Myers Squib.

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BMY ---

Arena Pharmaceuticals: Last week at the Newsmakers in Biotech conference the company said it would be out within a few weeks with updated safety results on its experimental weightloss pill. Turns out it was just a matter of days. Arena says, so far, the drug doesn't have any Fen-Phen-like heart valve side effects. The company's looking for a corporate partner on the pill which will be tested in two more big clinical trials starting later this year. It'll be enrolling 6,000-7,000 people in those tests in case you're interested in being a guinea pig on a diet drug. Interestingly, the stock was trading higher pre-market, but after the conference call and the opening bell it went south.

Sepracor: The company best known for the luminescent butterfly in the commercials for its sleeping pill Lunesta signs a deal with GlaxoSmithKline. The drug giant will sell the drug under the name Lunivia everywhere except the U.S., Canada, Mexico and Japan. GSK is giving SEPR cash up front and then so-called milestone payments plus royalties on sales. Sleep deprivation is a big drug market.

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GSK ---

Dendreon: This volatile stock is up for the second straight day. An SEC filing says the French Bank BNP Paribas has bought nearly 7,000,000 shares of DNDN. 'Nuf said.

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DNDN ---

That's all for now. A busy morning, but the day is young.

 Print
So, I thought I'd be spending today monitoring the webcast of the FDA Advisory Committees that are meeting to decide whether doctors should use less of the anemia drugs from Amgen and Johnson & Johnson to treat kidney dialysis patients.
  Price   Change %Change
AMGN ---
JNJ ---
GSK ---
ARNA ---
DNDN ---

   
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