ADA: Empagliflozin versus placebo controlled patients with type 2 diabetes on...
In a 52-week study of obese adults with type 2 diabetes on high insulin doses with or without metformin, adding empagliflozin to multiple daily insulin injections significantly reduced blood glucose...
View ArticleADA: Empagliflozin added to metformin showed greater reductions in blood...
In a 2-year study, empagliflozin as add-on to metformin demonstrated significantly greater decreases in hemoglobin A1c (a measure of average blood glucose over the past 2 to 3 months), body weight and...
View ArticleFDA drug approvals-July 2014
Actions in brief Tavaborole (Kerydin, Anacor Pharmaceuticals) topical solution, 5% was approved, which is the first oxaborole antifungal approved for the topical treatment of onychomycosis of the...
View ArticleFDA drug approvals-August 2014
FDA Actions in BriefA new indication for eltrombopag (Promacta, GlaxoSmithKline) was approved for once-daily use in patients with severe aplastic anaemia who have had an insufficient response to...
View ArticleFDA approves Striverdi Respimat to treat COPD
FDA has approved olodaterol (Striverdi Respimat, Boehringer Ingelheim) Inhalation Spray 5 µg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with...
View ArticleAnother SGLT2 inhibitor for type 2 diabetes is approved
FDA has approved empagliflozin (Jardiance, Boehringer Ingelheim Pharmceuticals) as another option for adult patients with type 2 diabetes. Empagliflozin, a sodium glucose co-transporter 2 (SGLT2)...
View ArticleFDA approves empagliflozin tablets for type 2 diabetes
FDA approved empagliflozin (Jardiance, Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company) tablets as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels,...
View ArticleFDA drug approvals - October 2014
FDA actions in brief Dapagliflozin and metformin hydrochloride extended-release (Xigduo XR, AstraZeneca) once-daily tablet was approved for the treatment of adults with type 2 diabetes. Xigduo XR is...
View ArticleNew therapies approved for idiopathic pulmonary fibrosis
FDA approved the first two drugs for the treatment of idiopathic pulmonary fibrosis (IPF) on the same day—October 15. These new therapies for IPF are pirfenidone (Esbriet, Roche) and nintedanib (Ofev,...
View ArticleCholesterol-lowering agent leads list of most-prescribed drugs
Rosuvastatin (Crestor, AstraZeneca), a cholesterol-lowering agent, is currently the most-prescribed drug among the 100 most-prescribed and best-selling drugs in the United States. In the past 12...
View ArticleFDA analysis of dabigatran versus warfarin for nonvalvular AF questioned
A new study has found a greater bleeding risk associated with the use of dabigatran (Pradaxa, Boehringer Ingelheim) in patients with nonvalvular atrial fibrillation (AF) than that cited on initial FDA...
View ArticleWhat is new in the anticoagulant antidote market?
The use of new oral anticoagulants (NOACs) continues to increase. Over the past 4 quarters, rivaroxaban (Xarelto, Bayer/Johnson & Johnson) and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) were...
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Overall survival extended in afatinib-treated patients with specific lung...
Dr Sequist Afatinib extends overall survival in lung cancer patients whose tumors have the most common epidermal growth factor receptor (EGFR) mutation compared with chemotherapy, according to study...
View ArticleFDA approves combined drug to improve glycemic control in diabetes patients
The first-in-class combined medication for improving glycemic control in adults with type 2 diabetes has been approved by FDA. Glyxambi (empagliflozin/linagliptin, Boehringer Ingelheim/Eli Lilly)...
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Tiotropium improved asthma symptoms in phase 3 trials
New data from phase 3 trials showed that the addition of investigational tiotropium delivered via Respimat inhaler in adult patients with mild, moderate and severe asthma who continue to experience...
View ArticleFDA drug approvals-April 2015
FDA actions in brief An expansion onabotulinumtoxinA (Botox, Actavis) label was approved to include the treatment of adults with upper limb spasticity. The expanded label now includes the addition of...
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Personalized treatments for lung cancer underused: International survey
Despite the majority of newly diagnosed advanced non-small cell lung cancer (NSCLC) patients being tested for genetic mutations, a gap still exists for providing a personalized treatment plan for...
View ArticleFDA drug approvals-May 2015
FDA actions in brief Sirolimus (Rapamune, Wyeth Pharmaceuticals) was approved to treat lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily affects women of childbearing age....
View ArticleNew forum expands access to biosimilars
The need for credible, sustained, and unbiased biosimilars education has fueled the development of the Biosimilars Forum. The Biosimilars Forum was launched on May 5, 2015 as a non-profit organization...
View ArticleOnce-daily maintenance combo drug approved for COPD
FDA approved once-daily tiotropium bromide and olodaterol (Stiolto Respimat, Boehringer Ingelheim) Inhalation Spray as a long-term, once-daily maintenance treatment of airflow obstruction in patients...
View ArticleDosage breakthrough for schizophrenia drug, plus 5 more FDA approvals
FDA has approved the first and only 4-times-per-year schizophrenia drug. Three-month paliperidone palmitate (Invega Trinza, Janssen Pharmaceuticals) injection, atypical antipsychotic was approved...
View ArticleAmlodipine, marginal pupil dilation link explored in study
Take-Home Message: A calcium channel blocker may be associated with marginal pupil dilation, making it more likely that pupil-dilating devices will be needed during phacoemulsification. By Lynda...
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Partnering on COPD for savings, outcomes
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the United States, affecting up to 24 million adults. The lung disease cost the healthcare system $32.1 billion in...
View ArticleDiabetes drug may reduce stroke, CV deaths
Jardiance is the first diabetes drug that has also been shown to lower strokes, heart attacks and cardiovascular deaths, according to a new study. Related: Heartburn drugs linked to heart attacks The...
View ArticleFDA approves Synjardy for type 2 diabetes
FDA has approved empagliflozin and metformin hydrochloride (Synjardy, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company) tablets for the treatment of adults with type 2 diabetes...
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