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.

Wednesday, May 25, 2011

ATTAINing Europe

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

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

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

Monday, May 9, 2011

Avibactam at ECCMID

Image via CrunchBase I hope all of you are wondering what on earth avibactam is. It is the generic name for Novexel’s (was Sanofi-Aventis’...

Monday, May 2, 2011

Antibiotics at FDA vs. EU - Compare and Contrast

Image via Wikipedia I just ran across something so striking, I had to share it with you. The European Medicines Agency (EMA) just released...

Thursday, April 28, 2011

The Death of Large PhRMA

Image via Wikipedia Two news items filtered out over the past several weeks that inspired me to write this blog. I liked these stories sin...

Saturday, April 23, 2011

Nabriva announces positive results in a phase II ABSSSI trial

Finally I have some good news to share. On a personal note, I have been working with Nabriva since 2005, well before they were spun ...

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