FDA Approves Generic Abilify After Unusual Legal Battle With Otsuka Pharmalot: WSJ By Ed Silverman 04/29/2015 Otsuka Pharmaceuticals was dealt a setback yesterday when the FDA approved four generic versions of its best-selling Abilify® antipsychotic pill, following an unusual and protracted legal battle. Shortly thereafter, Teva Pharmaceuticals announced that it was launching a copycat medicine. […]
I missed something. In the spice must flow…, I was looking at the two papers recently published about Brexpiprazole, a new Atypical Antipsychotic and found the the only academic authors were from the same faculty and research institute: Efficacy and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A 6-Week Randomized, Double-Blind, Placebo-Controlled Trial […]
Well, this can’t be a book review of Lieberman’s and Ogasi’s Shrinks, the Untold Story of Psychiatry or Whitaker’s and Cosgrove’s Psychiatry under the Influence because I’ve read neither, but we all have a pretty good take on what they’re about. What struck me is that the titles could be interchanged, and they would still […]
I don’t actually believe that most of the patients who showed up in my office looking for help were afflicted with a biologically determined brain disease, but from the first case I ever saw of melancholic depression to the present, I never doubted that biology was the major player in that condition. One of the […]
And so another atypical antipsychotic may be dripping from the FDA Approval pipeline… US FDA accepts Otsuka and Lundbeck’s filing for review of brexpiprazole for the treatment of schizophrenia and as adjunctive therapy for the treatment of major depression Lundbeck Press Release September 24, 2014 H. Lundbeck A/S [Lundbeck] and Otsuka Pharmaceutical Co., Ltd. [Otsuka] […]
In Academic·Industrial·Complex II… I was implying that the $700,000 spent on the study of Seroquel XR® in Borderline patients was a waste of money, but another way of looking at that is that their various trials of Seroquel XR® were overall worth it, because Seroquel® stayed in the Blockbuster range even after the patent expired […]
Several years ago, I ran across a business magazine cover with a high level AstraZeneca executive being praised for figuring out how to extend the patent life of their blockbuster Seroquel® by getting Seroquel XR® approved. I could never find it again. I still feel the loss because it proved that Seroquel XR® was just […]
Now that the case of Dan Markingson’s 2004 suicide is no longer in the realm of unacknowledged tragedy, moved into the public domain by two recent reports villifying the University of Minnesota’s Administration and Clinical Trials program for its handling of the case throughout, we can begin to think about what it all means. The […]
Note: The rain lowers the "count" but the more sensitive instruments [like the nose] still register its presence… [cut short by external events…]
After graduating from high school in 1960, we scattered to the winds – at least I did. It would be decades before I caught up with the people from those days and heard the stories of how those friends from my earlier life negotiated the tumultuous years that followed. Howard and I reconnected 40 years […]