Antibiotics - The Perfect Storm

We need new antibiotics to fight infections caused by resistant bacteria. But the marketplace, the structure of the pharmaceutical industry, regulatory agencies, and difficult science are conspiring to deny us the products we need. This blog will present perspectives and developments in the fight for new antibiotics.

Tuesday, November 30, 2010

More Bad News from Neverland. The FDA Guidance on Nosocomial Pneumonia.

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Image via Wikipedia The FDA has just released its new Draft guidance on clinical trial design for antibacterial drugs in the treatment of ...
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Wednesday, November 24, 2010

Ear Infections - Round 2

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Image via Wikipedia A recent article appeared in the Journal of the American Medical Association regarding the treatment of infections of ...
Saturday, November 20, 2010

The Infectious Diseases Society Sounds Off on the FDA and Skin Infections

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Well, boys and girls, it looks like at long last, the Infectious Diseases Society of America (IDSA) has taken off the gloves.  I guess they...
Tuesday, November 16, 2010

Antibiotics, Incentives and Disincentives - continued.

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Going back to that article by Andy Pollack in the NY Times , he includes a graphic from the FDA showing a substantial increase in the numbe...
Tuesday, November 9, 2010

Antibiotics and Incentives

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A recent article by Andrew Pollack in the New York Times discussed the idea of incentives for the pharmaceutical industry to encour...
Tuesday, November 2, 2010

Ear Infection - Antibiotics Work!

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The data are in!  The NIH funded placebo-controlled trial of augmentin vs. placebo in children ages 6 months to two years with well docum...
Thursday, October 21, 2010

More on FDA Thinking

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In the Oct. 14 issue of the New England Journal , Dr. Susan Okie writes about Drs. Hamburg and Sharfstein’s efforts to “revive” the FDA (an ...
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