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A Patch? YES – A Fix? NO: This Emperor Has No Clothes

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The NIH Department of HHS released its Final Rule on “Clinical Trials Registration and Results Information Submission” [1]. This Rule is meant to address frustrating maintenance and compliance issues in the ClinicalTrials.gov database, especially the results reporting section which has been neglected or totally ignored, (we commented on this in Continue reading A Patch? YES – A Fix? NO: This Emperor Has No Clothes→

Timely New Information on Next-Generation Tetracyclines – Part 1: Omadacycline and Cardiac AEs

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Several interesting articles appeared recently which shed light on the efficacy of eravacycline and the safety of omadacycline, both in Phase 3 and both in a head-to-head race to the market.  Well, the term ‘race’ is bit of a stretch as both drugs have seen very significant delays in development. Omadacycline from Continue reading Timely New Information on Next-Generation Tetracyclines – Part 1: Omadacycline and Cardiac AEs→

The EpiPen Episode, an Epitaph on Epinephrine as we know it, an Epilogue and an Epiphany

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For a good long time, economists have been thinking about the reimbursement quandary for antibiotics, esp. antibacterials. They are just too cheap, right?  Well, with the exception of HCV and some newer HIV drugs, few compounds have ever reached the stratospheric prices that oncology drugs or TNF alpha inhibitors command. Continue reading The EpiPen Episode, an Epitaph on Epinephrine as we know it, an Epilogue and an Epiphany→