Monthly Archives: July 2007

Neurochem Gets Approvable Letter

Posted on July 18, 2007 by Mark Senak

The FDA has issued another approvable letter – this time to Neurochem for eprodisate (KIACTA(TM)) for the treatment of Amyloid A (AA) amyloidosis.  This was not good news on two fronts – first, it was the product’s second approvable letter … Continue reading →

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What’s at Stake with Formal Dispute Resolution

Posted on July 17, 2007 by Mark Senak

Recently, two pharmaceutical companies announced that they would be seeking Formal Dispute Resolution (FDR) because of FDA decisions regarding their products.  Genta announced in April that the company would be filing one over a non-approvable letter for their investigative product … Continue reading →

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A Look at GSK’s alli Blog

Posted on July 16, 2007 by Mark Senak

As mentioned last week, I was directed by a colleague to a new blog being sponsored by GlaxoSmithKline about it’s new OTC product alli.  Because this is so highly unusual, it merits a closer examination. First of all – a … Continue reading →

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Weekly Roundup – 7-13-07

Posted on July 13, 2007 by Mark Senak

Looking back at the week, some things just stand out.  Across the country it was a hot, hot week.  Triple digits nearly all over the West and wildfires breaking out in several states.  There were wildfires here inside the Beltway … Continue reading →

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Another Pharmaceutical Blog!

Posted on July 12, 2007 by Mark Senak

Well, no sooner did I find the Johnson & Johnson sponsored blog, JNJ BTW, last week than a colleague brought to my attention another blog – this one by GlaxoSmithKline and this one product-specific!  The blog is called alli-connect – … Continue reading →

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