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) control and [...]

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 unfamiliar with [...]

Pneumococcal Disease In Children

In follow up to our discussion of pneumococcal conjugate vaccines yesterday, we thought readers would benefit from a brief review of the diseases that these vaccines are designed to prevent.
Clinical Presentations
Streptococcus pneumoniae causes acute bacterial infections. Also referred to as the pneumococcus bacteria, it was first isolated by Pasteur in 1881. Prior [...]

DAC GLP-1 for Type II Diabetes

On April 12, 2004 ConjuChem Inc. announced interim Phase II results for DAC™: GLP-1. The company released results for patients who had received the first 28 days of therapy of the planned 3 month trial. Based on approximately 80 patients to date, ConjuChem reported a statistically significant reduction in Hgb A1C and glucose normalization or [...]

Exubera

On Thursday March 4, Aventis SA and Pfizer Inc. stated that the European Medicines Evaluation Agency has accepted the filing of a marketing authorization application for Exubera (human insulin powder). The companies are seeking approval to market Exubera for adult patients with Type 1 and Type 2 diabetes. Pfizer and Aventis have been working with [...]