May 23, 2017 Off

AstraZeneca’s Bydureon EXSCEL trial meets type-2 diabetes safety objective

By Dino Mustafić

AstraZeneca has reported top-line results from the Phase IIIb/IV EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial that compared the effect of once-weekly Bydureon (exenatide extended-release) versus placebo, when added to usual type-2 diabetes care, on the risk of MACE, a composite endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke, in adults with type-2 diabetes (T2D) at a wide range of CV risk.

May 23, 2017 Off

Sanofi and Regeneron win FDA approval for its rheumatoid arthritis drug

By Dino Mustafić

The U.S. Food and Drug Administration (FDA) has approved Sanofi’s and Regeneron Pharmaceuticals’s Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX).

May 23, 2017 Off

Novo Nordisk submits application in the US for label addition for its diabetes drug

By Dino Mustafić

Novo Nordisk has submitted a supplemental application to the US Food and Drug Administration (FDA) for including data in the label for Tresiba (insulin degludec) from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba compared to insulin glargine U100 when added to standard of care, in people with type 2 diabetes.

May 22, 2017 Off

Anavex presents new data for certain neuro-diseases tratment

By Dino Mustafić

Anavex Life Sciences, a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer, has announced new preclinical data for ANAVEX 2-73 in the neurodevelopmental disorders Angelman syndrome, Fragile X syndrome and Rett syndrome.