The Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), has issued a positive opinion for three new…
Category: Products & Tech
AstraZeneca and Bristol-Myers Squibb Company resubmitted a New Drug Application (NDA) to the U.S. FDA for the investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. The FDA assigned a new Prescription Drug User Fee Act (PDUFA) goal date of Jan. 11, 2014.
In anticipation of stable, liquid glucagon, one of the newest entrants into the insulin pump space, Tandem Diabetes Care has jumped ahead of the crowd and created a two-chamber infusion pump capable of holding and injecting both insulin and a secondary hormone, which they expect will be glucagon. This tandem Tandem pump is already being tested in Dr. Ed Damiano's clinical trial of a dual-hormone bionic pancreas.
There are almost one million apps in the iTunes store, and when you consider all the apps unique to Android phones, the choices can be overwhelming.…
Japan's Ministry of Health, Labor and Welfare (MHLW) approved the manufacturing and distribution of Sanofi's new type 2 diabetes treatment, Lyxumia (lixisenatide) in Japan.
Lyxumia, the first once daily prandial GLP-1 receptor agonist (RA), is also the first GLP-1 RA approved in Japan...
Nationwide Children’s Hospital recently developed an online resource to help parents manage their child’s diabetes more effectively and better…
Biodel has announced plans to submit a New Drug Application (NDA) to the FDA in 2015 for a novel glucagon rescue device to treat severe hypoglycemia.
Having previously signed a long-term commercial supply agreement for bulk glucagon, Biodel expects to select a final formulation of its novel glucagon therapy...
Results of the Novartis-sponsored INTERVAL study have demonstrated the feasibility of setting and achieving individualized treatment targets in elderly patients with type 2 diabetes treated with Novartis drug, Galvus (vildagliptin).
Abbott Diabetes Care has initiated a voluntary recall of FreeStyle lnsulinx Blood Glucose Meters in the United States.
The glucose meters are…
Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration…