The creation of oral insulin has been no simple task. "People have been dreaming about oral insulin since 1922," Dr. Kidron said...
Tag: Oral Insulin
MannKind Corporation announced that it has confirmed with the U.S. Food and Drug Administration the design of two clinical studies that evaluate the efficacy and safety of AFREZZA (insulin human [rDNA origin]), an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind's next-generation inhaler...
Treating type 1 and type 2 diabetes with investigational ultra rapid acting mealtime insulin Afrezza (insulin human [rDNA origin]) Inhalation Powder does not result in excess cardiovascular events according to two new studies being presented at the American Diabetes Association's...
The FDA's Center for Drug Evaluation and Research has issued a complete response letter to Mannkind corp. regarding the New Drug Application (NDA) for Afrezza (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes...
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...
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...
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...
Novo Nordisk has announced the signing of an exclusive Development and Licence Agreement with Emisphere Technologies, Inc. to develop and commercialize oral formulations ofNovo 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...
MannKind Corporation representatives at the 10th annual meeting of the Diabetes Technology Society unveiled new data on its drug delivery, device and particle technologies demonstrating the bioequivalence, ease of use and efficiency of the company's novel platform. The company presented four studies evaluating...
MannKind Corporation announced that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted, MannKind's resubmission of its New Drug Application (NDA) for AFREZZA(TM) (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding...