Non-invasive glucose monitoring system
Labopharm Inc. has announced that its New Drug Application (NDA) for the Company’s novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder, has been accepted for review and filed by the U.S. Food and Drug Administration (FDA). The action date under the Prescription Drug User
Full Post: FDA accepts Labopharm’s NDA for formulation of trazodone
Solianis has just finalised a test series in which patients with diabetes have worn the first configuration of the multisensor system for non-invasive Continuous Glucose Monitoring at home and at work.
Results show that the system tracks glucose in these settings and that it is sensitive to hyper- and hypoglycemic glucose excursions.
“This is the first study ever performed with any non-invasive glucose sensor in a home use environment. The data show clearly that the technology works and that we are on our way to the final product.” says Mario Stark, CEO of Solianis. The company expects to launch its first product in Europe in 2010 after CE approval, targeting this non-invasive device at the insulin dependent diabetes population. Later model variants will address patients with diabetes and impaired glucose tolerance.
To move forward with the implementation of the prototype and set up the market introduction, Solianis has strengthened its Board of Directors with two renowned industry experts:
Dr. Russ Potts holds a PhD in Biochemistry. He worked at Pfizer on transdermal drug delivery and at Cygnus as Vice President R&D until 2002. Cygnus developed the first FDA-approved, minimally-invasive, continuous glucose monitor “Glucowatch”. At Cygnus his responsibilities included FDA technical liaison & fund raising, with strategic as well as technical input. Today he is a consultant for drug delivery and glucose monitoring devices. His role at Solianis will include technical and patent support, recommendations for the approach to the FDA and strategic planning.
Dr. Anders Weber holds a Ph.D. in Immunology from the Royal Veterinary and Agricultural University of Copenhagen, and he has performed his post doctorate studies on optical immunosensors at the University of Michigan, Ann Arbor, and the Biotechnology Centre in Pittsburgh. He started his industrial career as Development Engineer at Radiometer A/S in Copenhagen as part of a team developing amperometric glucose and lactate sensors and subsequently headed the advanced Sensors Development Unit. In various capacities, he initiated and managed 12 start-up companies on behalf of Danish Development Finance Corporation and other investors.
A study in the Dec. 15 issue of the Journal of Clinical Sleep Medicine suggests that screening type 2 diabetes patients for obstructive sleep apnea (OSA) and treating those who have OSA with continuous positive airway pressure (CPAP) therapy could improve the management of their hyperglycemia and might favorably influence their long-term prognosis. Results
Full Post: Continuous positive airway pressure improves sleeping glucose levels in type 2 diabetics with obstructive sleep apnea
Titan Pharmaceuticals, Inc. today announced that it has received an Office Action from the U.S. Patent and Trademark Office (PTO) rejecting the claims in the Company’s method of use patent application for the use of Probuphine in the treatment of opioid addiction and chronic pain. Probuphine is Titan’s novel, subcutaneous implant formulation in development
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company’s Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the AB-rated generic equivalent of Ortho McNeil’s chronic pain treatment Duragesic. Shipment of this product has commenced.
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An important piece in the diabetes puzzle which has perplexed scientists for decades has been uncovered by a Sydney PhD student at Sydney’s Garvan Institute of Medical Research. The novel finding by Freddy Yip has revealed how insulin works and brings researchers one step nearer to understanding just how insulin prompts fat and muscle cells
Full Post: Sydney student solves piece of the diabetes puzzle
SurModics, Inc. announced today that it has acquired a portfolio of intellectual property and collaborative drug delivery projects from PR Pharmaceuticals, Inc., a drug delivery company specializing in injectable, biodegradable sustained release formulations. SurModics paid $3 million in cash at closing and may pay up to an additional $6 million in cash upon the
Full Post: SurModics acquires drug delivery assets of PR Pharmaceuticals