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 [...]

Torcetrapib for increasing HDL cholesterol

On April 7, 2004 Pfizer announced preliminary results of a Phase I trial with torcetrapib, its experimental therapy for increasing HDL cholesterol. A study was published in the April 8, 2004 issue of the New England Journal of Medicine, involving 19 patients. The results showed that torcetrapib significantly increased the level of high-density lipoprotein (HDL) [...]

Daxas (roflumilast)

On March 12, 2004 Altana AG announced that it had presented strong data on its Chronic Obstructive Pulmonary Disease (COPD) drug roflumilast, also known as Daxas, at a German scientific meeting. Daxas, which is to be jointly marketed with Pfizer, has been filed for marketing approvals in Europe. Altana has said it hopes Pfizer will [...]

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 [...]

Indiplon

Indiplon On February 18, 2004 Neurocrine Biosciences said that preliminary results from a late-stage clinical trial showed that its experimental sleeping pill, being developed in conjunction with Pfizer, works in elderly patients with chronic insomnia. Results from its Phase III clinical trial with two doses (5 mg and 10 mg) of the immediate release formulation [...]