Why Some Did Not Make It

There are numerous reasons why drugs get stuck in development.  Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well.  For instance regulatory issues or manufacturing, difficulties can stop a program.  Occasionally, a suboptimal dose was chosen because of (1) incomplete Continue reading Why Some Did Not Make It

The Circuitous Route to Phase 3:  Another Chapter in the Fitful Development of PTK-0796

When antibiotics change hands, it can be a good thing.  Small companies are often desperate to attract a partner with ‘deep pockets’ to help them finance an expensive late phase development but often have to give up control once the honeymoon period is over.  Such transitions can bring delays because new Continue reading The Circuitous Route to Phase 3:  Another Chapter in the Fitful Development of PTK-0796

Two New Approaches For Dealing with Sepsis / Toxemia

There is hardly an indication which has accumulated more failed clinical trials than the sepsis area.  Called first bacteremia, later sepsis, sepsis syndrome or septic shock, there have been numerous attempts to influence the cascade of events that eventually lead to MSOF and death.  While it is convenient to think Continue reading Two New Approaches For Dealing with Sepsis / Toxemia