Insulin | Page 16 of 16

FDA Clears Clibra’s Insulin Patch

Calibra Medical Inc., formerly known as Seattle Medical Technologies Inc., announced today that the U.S. Food and Drug Administration has given Finesse, the company’s insulin patch-pen, 510(k) clearance. Only 2” long, 1” wide and ¼” thick, Finesse is able to hold and deliver prescribed amounts of insulin over multiple days while...

FDA Needs More Time to Review MannKind’s New Drug Application for Inhaled Insulin

MannKind Corp. announced that it was informed today by the FDA that they will not be able to complete the review of MannKind's new drug application for its ultra rapid-acting insulin therapy by the action date of January 16, 2010.The FDA explained that it has not yet completed its inspection of the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind....

Biodel Inc. Submits New Drug Application to FDA for A New Form of Insulin

Biodel, Inc. announced that it has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for clearance to market of VIAject(R) as a treatment for diabetes. VIAjecta(R) is a formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. It is Biodel's most advanced product candidate and has been tested in more than 884 patients who participated in Phase 1, 2 and 3 clinical trials...

Is Lantus Insulin Linked to Increased Risk of Cancer? New Study Begins

Recently published studies suggested that insulin glargine (a synthetic insulin preparation marketed under the trade name Lantus), may be associated with a higher risk of certain cancers than other insulins or oral glucose lowering medications. However, these studies were unable to control for important factors such as obesity that may have driven the association...

Eli Lilly Announces The First 300-Unit Vial of Insulin

Eli Lilly and Company announced the availability of a smaller vial of insulin containing 3 mL (300 units), the first such vial in the United States. A typical vial of insulin contains 10 mL, or 1,000 "units" of insulin. Lilly developed this new smaller vial for use in hospitals based on feedback regarding the average duration of patient hospital stays.

Novo Nordisk Starts Phase 1 Trial With Oral Insulin

Novo Nordisk announced today that it has initiated its first phase 1 clinical trial with an oral insulin analogue (NN1952). The aim of the trial, conducted in Germany, is to investigate the safety, tolerance, exposure of drug and effect of NN1952 oral insulin in healthy volunteers and people with type 1 and type 2 diabetes...

Novo Nordisk: Progress Made in Oral Insulin Development

Lars Sorensen, Novo's chief executive, speaking at the Reuters Health Summit, said the company could introduce a oral insulin tablet to the market within six years. A number of companies have already tried to develop inhaled insulin, including Pfizer Inc, whose product Exubera, was discontinued in 2007. This form of insulin has raised concerns that it could cause lung damage.