Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
It can feel like the mountain stage of the Tour de France… A lot of effort goes into preparing for meetings with Regulators. There is also a lot we can learn at such meetings. Today we start a series of blogs detailing personal experiences and learnings, highlighting do’s and don’ts. Continue reading REGULATORY INTERACTIONS – 1
Dalbavancin has changed hands a few times in its development history, moving from Lilly to Vicuron, then Pfizer and ultimately Durata. The original NDA for dalbavancin was submitted to FDA on Dec. 21, 2004. Pfizer acquired dalbavancin as a “Phase 3 completed” drug ready for world-wide marketing on June 15, 2005. The Continue reading Dalbavancin Approval Issues: A Case of Much Ado About Nothing
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