JOURNAL BUSINESS vs EDITORIAL OVERSIGHT

New medical and science journals pop up in our mailbox on a biweekly basis.  Offers to join as Editor, solicitation for articles based on past publications, invitations for subject reviews come as unsolicited emails.  Medical publication houses, old and new, are expanding, adding more and more subspecialties to their established Continue reading JOURNAL BUSINESS vs EDITORIAL OVERSIGHT

AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1

Only now, a few days before the actual AMDAC meeting, the FDA’s Briefing Document becomes available to the public.  The topic of the December 5th meeting:  Reappraisal of the risk/benefit of fluoroquinolones (FQ) in approved but “mild, self-limiting” disease indications in light of new post-approval safety issues. The document is 617 Continue reading AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1

Here They Are: Dalbavancin and Oritavancin – The New Long-Acting Lipoglycopeptides

The development history of glycopeptide drugs is anything but normal.  Daptomycin (Cubicin®) was abandoned by Lilly but resurrected by Francis Tally at Cubist by adjusting the dosing schedule to once daily and careful uptitration.  The drug did superbly in a landmark endocarditis trial and everything looked rosy.  Then we learned Continue reading Here They Are: Dalbavancin and Oritavancin – The New Long-Acting Lipoglycopeptides