Brincidofovir – Another Drug Fails in Phase 3

It is sad to see a pivotal trial fail, and you have to wonder why we recently had several such late-stage ‘mishaps’. Take Tetraphase’s eravacycline which failed in a Phase 3 cUTI trial. We have analyzed this drug’s failure in earlier blogs; there is reason to believe that inadequate dosing was Continue reading Brincidofovir – Another Drug Fails in Phase 3

The 10 x ’20 Goal – Are We On Track?

In the last decade (2000-2010), we saw the number of new antibiotic approvals drop successively each year; FDA changed the rules of the approval process without providing public guidance; many antibiotic companies fled the therapeutic area; investments were redirected to oncology projects which had a much better ROI. The IDSA Continue reading The 10 x ’20 Goal – Are We On Track?

Mister S. Goes To Washington

Let’s just assume that Mr. Martin Shkrely had provided full testimony at the Congressional hearing, this is what it might have said: Read my lips: NO MORE REBATES !