QIDP Drug Update – Part 1: An Updated Who Is Who

It is time for a new look at the field of QIDP drugs. Today we are providing an updated searchable database which now has 57 entries. (Status: 10/18/16) Despite best efforts to provide accurate information, errors may have crept in. Please let us Continue reading QIDP Drug Update – Part 1: An Updated Who Is Who

Dalbavancin Approval Issues: A Case of Much Ado About Nothing

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” Continue reading Dalbavancin Approval Issues: A Case of Much Ado About Nothing

Plazomicin – A Quick Take On A Complex Drug With A Complex Development Path

Whenever a new drug is in late stage development, its prospects become the focus of intense scrutiny. Plazomicin (ACHN-490), like any Phase 3 drug should be evaluated along the following dimensions: Differentiation: within its class & compared to competitors: Does it Continue reading Plazomicin – A Quick Take On A Complex Drug With A Complex Development Path

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