[ Nutrition ]

Otelixizumab Developed by GSK and Tolerx Fails in Type 1 Diabetes Study


WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the initiation of a clinical trial to evaluate the combination of the company’s investigational anti-PD-1 immunotherapy, MK-3475, and GlaxoSmithKline’s orally administered kinase inhibitor, pazopanib, in advanced renal cell carcinoma. To explore this relationship, we have produced transgenic mice that overexpress human GSK-3beta in skeletal muscle. Diabetes is a chronic disease of insulin resistance and/or inability to produce insulin, a hormone essential to metabolism. The FDA is requiring postmarketing studies, including a trial to evaluate dosing, efficacy, and safety in pediatric patients; an MTC case registry of at least 15 years; and a cardiovascular-outcomes trial in patients with high baseline risk of cardiovascular disease. Moreover, data from two large head-to-head clinical trials—A Diabetes Outcome Progression Trial (ADOPT) [2] and the interim report of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial [3]—show that, apart from the well-documented risk of heart failure with thiazolidinediones, rosiglitazone has a cardiovascular risk profile comparable to the recommended tier 1 glucose-lowering medicines, metformin and sulfonylurea. Peak sales for this therapy were projected at $800 million by Deutsche Bank analysts, though many of these forecasts turn out to be wildly inaccurate. But its shares trade at 15 times estimated 2004 profits, compared with the industry average of 25.

They pay for a seat on ALEC task forces where corporate lobbyists and special interest reps vote with elected officials to approve “model” bills. DEFEND-1 is a randomized, placebo-controlled Phase 3 study of 272 patients, age 12 to 45, with new-onset Type 1 diabetes. The grants are each three-year awards. The company calls it the Maestro System, and says it’s a “pacemaker-like device” implanted to block signals along the nerves connecting the brain and stomach, helping people feel less hungry. Galvani will have a second research hub at Verily’s facilities in South San Francisco. Although not yet available, one aspect of the lens would be an LED light system that would light up to warn the wearer when glucose levels were too high or low.

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