Content about Inhalable insulin

September 30, 2011
Novo Nordisk seeks to market insulin products

Novo Nordisk is seeking approval for two new insulin products, the company said Thursday.

PRINCETON, N.J. — Novo Nordisk is seeking approval for two new insulin products, the company said Thursday.

Novo Nordisk announced that it had filed with the Food and Drug Administration for approval of insulin degludec and a co-formulation of insulin degludec and insulin aspart. The products are insulin analogs developed for the treatment of Type 1 and Type 2 diabetes.

July 6, 2011
MannKind: Patients have better view of insulin therapy when using Afrezza

Patients with Type 1 diabetes using an insulin product made by MannKind expressed a better opinion about insulin therapy than those taking the standard treatment, according to a study presented at the American Diabetes Association’s 71st Scientific Sessions.

SAN DIEGO — Patients with Type 1 diabetes using an insulin product made by MannKind expressed a better opinion about insulin therapy than those taking the standard treatment, according to a study presented at the American Diabetes Association’s 71st Scientific Sessions.

MannKind said that patients taking the investigational inhaled insulin Afrezza (insulin human [rDNA origin]) with basal insulin came to view insulin therapy more positively during the 16-week study than those taking Eli Lilly’s injected Humalog (insulin lispro [rDNA origin]) with basal insulin.

January 20, 2011
MannKind receives complete response letter for Afrezza

It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

VALENCIA, Calif. — It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

The Food and Drug Administration on Thursday issued a complete response letter to the drug maker regarding Afrezza (insulin human [rDNA origin]) inhalation powder. The regulatory agency requested that the company conduct two clinical trials, one in patients with Type 1 diabetes and one in patients with Type 2 diabetes, with its next-generation inhaler, to assure it works as effectively as MedTone, its predecessor.

January 3, 2011
Drug approvals low in 2010

This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

NEW YORK — This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.

The Wall Street Journal reported that 21 new drugs were approved through the year, compared with 25 in 2009 and 24 in 2008. The lag came in part due to stricter safety regulations, the newspaper reported.

June 24, 2010
MannKind presents Afrezza study at scientific meeting

An inhaled insulin made by MannKind for patients with Type 2 diabetes provides glycemic control...

March 15, 2010
FDA issues complete response letter for MannKind's Afrezza

The Food and Drug Administration did not approve an application from MannKind Corp. for a...