My first encounter with insulin came when I was diagnosed with gestational diabetes.  Being pregnant was hard for me. Being diagnosed with diabetes was harder.   And learning how to cope with insulin therapy was the hardest part of all.  If you’ve never used insulin, or been around someone using it, you might think the worst part of the therapy is the injection.  The injection is unpleasant, no doubt, but it isn’t the biggest downside to insulin therapy.  The worst thing about insulin therapy, by far, is the hypoglycemia...

Biocon Ltd., India’s largest biotechnology company, released preliminary data from a recently concluded clinical study conducted in India, on IN-105, its novel oral insulin candidate for the treatment of diabetes. The study included 264 patients poorly controlled on metformin, who were randomly chosen receive either IN-105 or placebo. The patients in both arms of the study were allowed to continue taking metformin as background therapy. Initial data analysis showed that IN-105 did not meet its primary end point of lowering...

MonoSol Rx and Midatech Group Ltd. anounced positive results from pre-clinical proof-of-concept studies for oral insulin delivery in Rhesus monkey studies and hope to begin human trials in 2011. The two companies are developing insulin PharmFilm under a partnership that leverages MonoSol Rx’s PharmFilm and Midatech’s biocompatible nanoparticles to develop orally bioavailable formulations of peptides and drugs. This partnership includes a joint venture set up to focus on the development and commercialization of products...

The FDA informed MannKind Corporation that it would not be able to complete the review of the New Drug Application (NDA) for AFREZZA (insulin human [rDNA origin]) Inhalation Powder by the action date of December 29, 2010. The FDA stated that it will require approximately four additional weeks to complete its review of the NDA. AFREZZA is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with type 1 and type 2...

Novo Nordisk has announced the signing of an exclusive Development and Licence Agreement with Emisphere Technologies, Inc. to develop and commercialize oral formulations of Novo Nordisk’s insulins. This is the second license agreement between the two companies.  The first agreement for the development of oral formulations of GLP-1 receptor agonists was signed in June 2008 with a potential drug currently in a phase 1 clinical trial. Novo Nordisk seeks to use Emisphere’s broad-based drug delivery technology platform for oral...

MannKind  announced that results of a new 16-week trial show that the investigational ultra rapid acting mealtime insulin, AFREZZA (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, is clearly non-inferior to standard therapy insulin lispro, a rapid acting insulin (also combined with basal insulin), in reducing HbA1c levels in subjects with inadequately controlled type 1 diabetes. In addition, patients treated with AFREZZA had statistically significant...

MannKind Corp. announced the results of a two year study comparing the efficacy and safety of AFREZZA (insulin human [rDNA origin]) versus usual diabetes care. The study followed patients for a total of up to two years. The patients were randomly assigned to a treatment regimen of either AFREZZA plus subcutaneous basal insulin or usual diabetes treatment regimens of any insulin. At the end of two years, there was a comparable reduction in HbA1c levels (by 0.29% and 0.31% in the AFREZZA and usual care groups,...

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. Results from the trial, which plans to enroll about 80 people, are expected to be reported in the first half of 2011. There are many challenges with the development and production of a reliable insulin formulation...

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. The main challenge for scientists trying to develop insulin tablets is that insulin degrades quickly in the stomach, meaning only a very small amount...