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.

Thursday, June 30, 2011

Antibiotics - Half Full or Half Empty

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Image via Wikipedia In my job as a consultant to companies trying to discover and develop new antibiotics, I keep my fingers on the pulse of...
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Sunday, June 19, 2011

Antibiotics in the US - Effecting Change

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Image via Wikipedia Once again I was privileged to be a participant in an ongoing conversation on antibiotic development and the FDA involv...
Monday, June 13, 2011

Dr. Margaret Hamburg on Biocentury TV

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Image by Getty Images via @daylife Yesterday I watched an interview with Dr. Margaret Hamburg, Commissioner of FDA on Biocentury TV .  In ...
Monday, June 6, 2011

Sanofi - Breaking the Mold?

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Image by sunxez via Flickr In 1999 Roche announced that they would abandon their effort to discover and market new antibiotics.  This ulti...
Wednesday, May 25, 2011

ATTAINing Europe

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Image via Wikipedia Europe comes through again!  EMA and CHMP have recommended approva l of Theravance-Astellas’ telavancin for use in nos...
Tuesday, May 17, 2011

Antibiotic Trial Design and FDA - a Discussion

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The current predicament of antibiotics within FDA can be traced back to the scandal around Ketek.   See my earlier blog on this. The FDA...
Tuesday, May 10, 2011

Antibiotics - Yet Another FDA Victim Bites the Dust

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The end of Advanced Life Sciences has arrived .   Advanced Life Sciences was formed in 1999.   In 2005, they acquired cethromycin, a keto...
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