Investors have also noticed these changes, says Leuchtenberger. Last week, Rib-X announced that it had raised US$18.7 million to help the company start phase III trials of an antibiotic that could target skin infections. “Without some of these positive developments this year, you’re looking at a number of companies that might not be around any more,” he says.

Shlaes, however, emerged from the telavancin meeting still doubtful, noting a continued focus on all-cause mortality. He says that, for now, he will continue to advise his clients to apply for approval in Europe first, where regulators have not been as demanding as the FDA. “I’ve been very optimistic about the whole thing,” he says. “But the FDA has to do something to show that it is actually rebooting.”

This article is reproduced with permission from the magazine Nature. The article was first published on December 4, 2012.

2 Comments

1. 1. bucketofsquid 12:52 PM 12/6/12

   Perhaps if we add a requirement that each person proven to be killed by a newly approved drug results in the death of a major stockholder or executive of the producing company, they won't find it quite so odious to do thorough testing. In particular they should focus on drug interactions that patients may be subject to under common treatments since this is a hospital acquired illness so they are already being treated for something else.

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2. 2. donnawanna 05:59 PM 12/8/12

   The 1(800) lawyers will be happy about their chances to sue more often. lol the "good" drugs are bad enough.

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