An estimated one thousand clinical trials have been conducted for gene therapies in the past 20 years, but to date, not a single drug has made it to FDA approval. However, we may be a step closer as Introgen today announced that it has filed applications with FDA and EMEA for marketing approval of Advexin, […]

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The New York Academy of Sciences held its kickoff last night of Scientists Without Borders. “It’s a Match.com for organizations and resources focused on helping the developing world,” said NYAS president Ellis Rubinstein.
The initiative so far consists of a just-launched wiki—and, as such, leaves a little to be desired in terms of content. But the […]

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If there’s one piece of pharma news that should come as no surprise, it’s FDA throwing a new drug back at its maker with a “Try again later.” After all, the agency spent last year handing out “approvable” letters like pharma hands out freebies. That’s why we’re surprised that analysts, reporters, and possibly […]

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News flowing from the American College of Cardiology meeting has been dominated by Vytorin. And after the presentation analyzing results yesterday, Miller Tabak analyst Les Fundleyter says, “We’re done for the conference in terms of the important stuff. Vytorin is the story this year.”
So what is Vytorin’s story exactly? Industry watchers say they are still […]

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A morning-after assessment of the proof of concept news reveals that while Alnylam CEO John Maraganore (below) thinks he’s on a “moonwalk,” it’s really just cloud nine reached by “nice, small steps.”
Alnylam Pharmaceuticals’ announcement last Friday that it had scored the industry’s first human proof of concept with RNA interference sure sounded like a big […]

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The follow-up to this week’s Vytorin flap has taken an ominous twist. And I’m not just thinking of threatened investigations and lawsuits. A handful of relatively prestigious publications have moved past criticizing Vytorin, Merck, and Schering-Plough and have begun to ask uncomfortable questions about statins in general and the whole idea of lowering cholesterol. In […]

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The award for goofiest attack on the FDA this week has to go to Senator Sherrod Brown (D-OH), who has asked the Congressional Research Service to look into the possibility of changing or eliminating FDA’s Fast Track designation, according to the Cleveland Plain Dealer.
The Plain Dealer no doubt thinks this makes sense. Last December, the […]

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