Dendreon faces Provenge approval challenges; Survey: biopharmaceutical manufacturers' budgets unchanged;

> Dendreon's announcement earlier this week that its cancer vaccine Provenge was a success in a Phase III trial elicited a euphoric response from investors, but a number of experts tell the Financial Times that the Seattle developer still faces some formidable obstacles before it can win an FDA approval. Report

> In a new survey of biopharmaceutical manufacturers by Genetic Engineering News, respondents indicated that most budget areas would likely remain unchanged over the next 12 months--good news for vendors in a tough economy. Report

> Good ol' Carl Icahn. Just when you think he's pushing hard enough, he pushes harder. The activist billionaire has called for Amylin Chairman Joseph Cook to throw in the towel. Icahn wrote Cook--who's also Amylin's former CEO--to tell the exec that he should just clear out his desk. Report

> Gilead Sciences has completed its tender offer for CV Therapeutics. Report

> Novartis' blood pressure drug Diovan failed to prevent atrial fibrillation in a study. Report

> Abbott Laboratories may have increased first-quarter profits by more than 50 percent, but those numbers came with two caveats: One, about half of the the profits leap is due to a one-time, $797 million gain on the wrap-up of a partnership with Takeda Pharmaceutical (plus other items). Two, Abbott's top-selling Humira is facing a decline in demand as newly cost-conscious patients back away from the pricey anti-inflammatory. And that doesn't bode well for the rest of 2009. Report

> Johnson & Johnson has decided not to launch a stand-alone wellness and disease-prevention unit. Report

> Facing the patent cliff, looming regulation changes and generic competition, pharma companies are under pressure to produce new drugs faster and cheaper. And in an effort to promote a culture of innovation, pharma companies are increasingly going the way of biotechs and scrapping their large research units for smaller divisions. Report

And Finally... Karl Rove, Howard Dean, Bill Frist and Tom Daschle will debate healthcare reform at the upcoming annual meeting of BIO in Atlanta. Georgia BIO president Charles Craig expects "lively discussion." Report