Keryx shares rise on Zerenex safety data; Dendreon plans Provenge filing;

> Shares of Keryx Biopharmaceuticals shot up Wednesday afternoon after the developer announced that the renal disease therapy Zerenex was safe for long-term use. Story

> CombinatoRx has received an FDA Advisory Committee's endorsement for its pain drug Exalgo after the panel backed the company's REMS program for the drug. A final FDA decision on the drug is expected by November 22. Report

> Dendreon said today that it plans to seek marketing approval for its cancer therapy Provenge in mid-November, with a regulatory decision in mid-2010. Report

> Cell Therapeutics has dropped its bid to win European approval for the non-small cell lung cancer drug Opaxio, instead focusing on a late-stage trial for ovarian cancer. Story

> The FDA has granted a priority review for Cephalon's jet lag drug Nuvigil. Report

Pharma News

> The good news: Genzyme says it's successfully restarted the Allston Landing plant shut down earlier this year because of contamination. The bad: It's not likely to turn out product as quickly as investors hoped. Report

> Merck chief Richard Clark (photo) says his company is making good on its promise to publish details of its payments to doctors. Clark told the Financial Times that Merck will launch its doc-disclosure list next quarter, adding that "the system needs to be totally transparent." Report

> Here's a turnabout for you: George W. Bush's FDA chief is joining a think-tank effort to overhaul the agency, the WSJ Health Blog reports. Andrew von Eschenbach has signed on as an adviser to the Center for Health Transformation, the brainchild of Newt Gingrich. His task: To lead the charge on the think-tank's 21st Century FDA Modernization Project. Story

Vaccine News

> Two new studies came out this week that could play a big role in shaping the market for seasonal flu vaccines. Article

> After the vaccine industry gears up for the huge global campaign against swine flu this fall, the World Health Organization is expected to ask major manufacturers to blend their swine flu vaccines into the annual supply of seasonal influenza vaccines. Report

> Last week, Merck announced it was parterning up to launch a non-profit vaccine developer in India. This week it's touting plans to donate $500 million worth of its HPV vaccine Gardasil to help protect women in developing countries from cervical cancer. Report

Also Noted... Scientists recently named a new species of chimaera, an ancient and bizarre group of fishes distantly related to sharks, from the coast of Southern California and Baja California. Release

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