By
AmyT on
November 29, 2011
Ten days ago, I got a last-minute invitation to attend a small Bay Area JDRF event at the Four Seasons Hotel in Palo Alto, in the heart of Silicon Valley. This is where technology happens. It turns out, this diabetes-tech-update event has been going on for a few years. I was especially excited, because the theme of this year’s program was FDA Reform: How Can We Remain Competitive While Protecting Public Safety? Now that sounded…
Read more »
By
AmyT on
January 24, 2011
I can’t help it. This reminds me of the movie City Slickers, in which one of the characters has messed up his life, and his friends tell him he’s getting a “do-over.” The young company Dance Pharmaceuticals, based in downtown San Francisco, is basically on a mission to salvage the good parts of Pfizer’s failed inhaled insulin Exubera (not the awkward delivery device!) and launch a second coming of the base product that is “simpler,…
Read more »
By
AmyT on
December 11, 2008
There are a lot of things going on at the troubled Food and Drug Administration right now that could have a profound impact on the future of diabetes care, but most of us patients never hear about them. And that’s a damn shame. Because we stand at a crossroads.
You may or may not be aware that the Obama Administration is about to appoint a new FDA Commissioner. The politics and personal leanings of this…
Read more »
By
AmyT on
September 5, 2008
This morning Novo Nordisk announced that the FDA has scheduled an advisory committee meeting for its new Liraglutide once-daily GLP-1 drug, currently awaiting FDA approval. Believe it or not, this is huge news — with the potential to make or break a multi-billion-dollar diabetes drug category and set the tone for FDA safety proceedings in years to come.
What the FDA has done is to push off approval of Novo’s new Type 2 diabetes drug, over…
Read more »
