Drug

Amylin, Lilly, and Alkermes Await FDA Decision on Byetta for Diabetes

On February 25th, 2010, Amylin, Lilly, and Alkermes announced in a press release that the FDA had set March 12th 2010 as the Prescription Drug User Fee Act (PDUFA) action date for Byetta’s long acting formulation –  exenatide once weekly.   Our readers will recall that Byetta is used by type 2 diabetics for glycemic (blood glucose)... Read more of this article

Oral Therapies for Multiple Sclerosis – Fingolimod (FTY 720) and Cladribine: How Close are Novartis and Merck KGaA to FDA Approval?

These are interesting days for the first oral therapies targeting multiple sclerosis (cladribine and  fingolimod or FTY720) indeed, with both positive and negative events making news over the last several weeks.  On November 30th 2009,  Reuters reported that the FDA had issued Merck KGaA a ‘refuse to file’ letter, which in effect is... Read more of this article

MannKind’s AFREZZA vs. Pfizer’s Exubera: Will Inhaled Insulin Be Different This Time?

With an FDA decision pending on Mannkind Corporation’s AFREZZA (TM)  (insulin human (rDNA origin) Inhalation Powder – formerly named AFRESA ) and the recent failure of the first inhaled insulin to receive FDA approval, we thought it would be helpful to provide an analytical approach to this emerging health technology. For those who are... Read more of this article