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, August 31, 2010

Markey and Grassley as Brutus.

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First, there was Ketek (telithromycin).  Then there was the spectacular FDA nosedive into gagaland as far as antibiotics are concerned. Now,...
Friday, August 27, 2010

Guidance?

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Image via Wikipedia The long-promised Draft Guidance on Acute Bacterial Skin and Skin structure Infections (ABSSSI): Developing Drugs for T...
Friday, August 20, 2010

Watershed or Waterloo for Antibiotics?

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On September 7, the FDA Anti-infectives Advisory Committee will review the New Drug Application for ceftaroline submitted by Cerexa/Forest. ...
Thursday, August 12, 2010

FDA and IPO

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This week Trius, a biotech in California, went to the public markets in an attempt to raise money to support its proposed Phase III trials f...
Friday, August 6, 2010

Discounting Antibiotics

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No, this is not about cheap Z-packs (azithromycin) on the Internet.  From an online dictionary – discount - to leave out of account; disrega...
Saturday, July 31, 2010

FDA's Woodcock Testifies on Antibiotics

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Image via Wikipedia But I don’t get it. Dr. Janet Woodcock testified before the committee on energy and commerce subcommittee on health in...
Thursday, July 22, 2010

Why Avandia Threatens New Antibiotics

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To continue on our theme of Avandia and antibiotics, I notice that the FDA has now put Avandia’s safety trial on hold while they sort out...
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