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Endocrinology

Two Prime Therapeutics Studies Examine Diabetes Costs, How Appropriate Preventive Care Can Improve Outcomes

ST. PAUL, Minn.–(BUSINESS WIRE)–Two new studies find commercially insured members with diabetes had 2.5 times higher medical and pharmacy spending than members without diabetes matched by age, sex, state of residence and insurer. But those taking a cholesterol-lowering statin for primary prevention of heart disease – a common complication of …

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Enteris BioPharma and Sanofi Enter Deal to Develop Oral Diabetes Drug

BOONTON, N.J., Jan. 23, 2017 /PRNewswire/ — Enteris BioPharma, Inc., announced today the initiation of a feasibility study agreement with Sanofi to leverage Enteris’ proprietary and patented oral peptide and small molecule delivery platform, Peptelligence™, to develop an oral formulation of one of Sanofi’s preclinical stage peptides. Joel Tune, Chief …

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FDA Approves Synjardy XR Tablets for Adults with Type 2 Diabetes

RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 12, 2016 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Synjardy® XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. When used along with diet and exercise, SYNJARDY XR is indicated to improve blood sugar in adults with …

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FDA Warns Diabetes Drug Pioglitazone May Increase Risk of Bladder Cancer

[12-12-2016 ] As a result of an updated review, the U.S. Food and Drug Administration (FDA) has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines …

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FDA Approves Jardiance to Reduce CV Risk in Patients with Type 2 Diabetes

RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 5, 2016 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) approved a new indication for Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. JARDIANCE is the first type 2 diabetes treatment approved with …

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FDA Approves Sanofi’s Soliqua for Treatment of Type 2 Diabetes

Paris, France – November 21, 2016 – Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved once-daily Soliqua (TM) 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 …

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Novo Nordisk’s Diabetes Drug Xultophy Wins FDA Approval

PLAINSBORO, N.J., Nov. 21, 2016 /PRNewswire/ — Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for Xultophy®100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Xultophy® 100/3.6 is a once-daily, combination of Tresiba® (insulin degludec …

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FDA Grants Orphan Drug Designation to Genexine’s Investigational Growth Hormone Deficiency Drug

SEONGNAM, South Korea–(BUSINESS WIRE)–Genexine (KOSDAQ: 095700), an innovative biotechnology company focused on immuno-oncology, metabolic and orphan diseases, announced today that US FDA Office of Orphan Products Development (OOPD) has granted GX-H9 an orphan drug designation for the treatment of growth hormone deficiency. GX-H9 is next-generation, long-acting recombinant human growth hormone …

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Allergan Expands Gastroenterology Pipeline through Acquisition of Motus Therapeutics

DUBLIN and BOSTON, Oct. 27, 2016 /PRNewswire/ — Allergan plc. (NYSE: AGN), a leading global pharmaceutical company and Rhythm Holding Company, LLC, which owns Motus Therapeutics, Inc. a biopharmaceutical company developing peptide therapeutics for the treatment of gastrointestinal (GI) disorders, announced today the top line results of a Phase 2b clinical …

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Gilead Discontinues PAH and DKD Tests After Mid-Stage Failure; Advances NASH Treatment into Phase III Trials

FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 20, 2016– Gilead Sciences, Inc.(Nasdaq:GILD) today announced the top-line results from three Phase 2 studies of GS-4997 (selonsertib), an investigational inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in nonalcoholic steatohepatitis (NASH), pulmonary arterial hypertension (PAH) and diabetic kidney disease (DKD). GS-4997 demonstrated anti-fibrotic activity in an …

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