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David Shlaes
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The FDA, Ketolides and the Cempra Decision
OK.   So this is a few
months late. Mea culpa.   But since the
FDA advisory committee meeting on Cempra’s solithromycin, I have had a number
of questions from readers and colleagues on the FDA decision to request
additional safety information before approvi...

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Antibiotics - Recent Developments
Thanks to John Rex for notifying me about the two
developments I will discuss here. The first is an upcoming (March 1) FDA Workshop entitled,
“Current State and Further Development of Animal Models of Serious Infections
Caused by Acinetobacter baumannii and...

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The New Antibiotic Paradox
For the past decade or more the Wellcome Trust, BARDA and
others have been funding antibiotic research at various levels from early
discovery through preclinical and clinical development. Some of these projects
have poor commercial potential.   This is
clea...

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Funding the New Business Model for Antibiotics - USA.
As we’ve discussed previously, Europe should have an easier
time funding new business models for antibiotics.   They already have the structures in place,
given their socialized system, to provide insurance payments or market entry
rewards (for background –...

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The Perfect Storm Evolves
Here we are in 2017.   Happy New Year everyone! Once again I find myself with mixed feelings going into the New
Year. The perfect storm has evolved to become a mix of regulatory reform and
political turmoil. I am optimistic on the regulatory front and on th...

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Aminoglycosides in the News
The title of this blog almost sounds like an oxymoron.   Aminoglycosides are boring, aren’t they? And
they’re old! But with the onward march of antibiotic-resistant infections,
could it be that the aminoglycosides are going to become not only news but
clini...

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The Threat to FDA
As many of you know, I have had my “disagreements” with the
FDA over the years.   But I have never
questioned the fact that without the FDA, we would all be in a world of
trouble. Just look at what’s happening with supplements and you’ll begin to understand...

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The 21st Century Cures Act and Antibiotics
It looks like congress is finally going to pass the 21 st Century Cures Act . Its 996 pages long! 
Please read it yourself (just kidding). Of course, this doesn’t even
come close to France’s labor laws at 3500 pages – but its still impressive. The
bill cont...

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Pathogen-Specific Antibiotics - Business Models
I just returned from giving a talk to microbiologists on the
issues surrounding the clinical development of antibiotics with activity
against specific pathogens – that is – the opposite of so-called broad-spectrum
drugs. I used as an example an antibiotic t...

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FDA Needs a Few Good People - But Can't Hire Them
A recent article in the Washington Post caught my eye.   The
FDA apparently has over 700 vacancies in its drug evaluation group. This lack
of resource is holding up drug reviews. According to the piece, Dr. Janet
Woodcock complains that qualified candidates...
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