Post-BIO News Roundup
May07

Post-BIO News Roundup

Been focusing on Chicago and this year's BIO extravaganza all week? Here's a sampling of news you might have missed. Pirfenidone rejected In a surprisingly twist, FDA refused to approve InterMune’s lung treatment pirfenidone, despite a positive recommendation from its advisory committee. The agency wants another lengthy trial to better demonstrate pirfenidone is effective at treating idiopathic pulmonary fibrosis, a debilitating and ultimately fatal lung disease for which there are no approved treatments in the U.S. or Europe. InterMune’s stock fell over 75% on the news. Check out this piece in Forbes' health care blog on whether FDA is these days less likely to listen to its advisory panels. Birth Control Pill Exalted The mainstream media celebrated as "The Pill" turned 50. Technically, they're celebrating the 50th anniversary of its approval by FDA. C&EN covered the chemistry story of the pill in "The Top Pharmaceuticals That Changed The World" special issue, back in 2005. Don't miss the classy 1950s era photo of Carl Djerassi. Resveratrol Trial Halted A GlaxoSmithKline clinical trial studying a reformulated version of resveratrol was suspended on April 22 due to safety concerns, but company officials say the complications may or may not be related to the drug. The big question remains-what does this all mean for the effort to make drugs out of resveratrol, the trace component of red wine that's been touted as a cancer fighter and a fountain of youth in a bottle? Resveratrol research has been in the spotlight a lot lately, not just for good reasons. GSK got the reformulated resveratrol (also called SRT-501) when it acquired biotech company Sirtris in 2008, to the tune of $720 million. Sirtris based its business around evidence that resveratrol turned on enzymes called sirtuins. The belief was that this activity could underlie some of resveratrol's beneficial effects. Sirtris developed other drug candidates based on this idea that the company says look nothing like resveratrol, and some of those entitites are in clinical trials as well. But the sirtuin connection has been called into question on multiple occasions. And now, with news that some patients in the resveratrol clinical trial developed cast nephropathy, a condition that can lead to kidney failure, the Wall Street Journal Health Blog is wondering aloud whether resveratrol's 15 minutes of pharmaceutical fame are coming to an end. GlaxoSmithKline officials say they are studying the data further, and that they stopped the trial "out of an abundance of caution", according to the Wall Street Journal. The trial was conducted in patients with multiple myeloma, and apparently, cast nephropathy is common in myeloma patients. Commenters at "In the Pipeline" (which, by the...

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