Parkinson’s Disease Research: For First Time in Years, FDA approves New Drug as Add-on Therapy for Parkinson’s

Parkinson's, Xadago
By By Tomislav Babic, MD, PhD, Vice President, Neuroscience Franchise, Worldwide Clinical Trials,

The FDA approved Newron Pharmaceuticals, Zambon and US WorldMeds’ Xadago (safinamide) as an add-on therapy to levodopa/carbidopa for patients with Parkinson’s disease, the companies announced Tuesday, March 21, 2017. The new drug received European marketing authorization in February 2015 for the treatment of Parkinson’s disease (PD). The approval covers the indication “safinamide as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients.

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Cardiovascular Research and Drug Development: What’s Next in Heart Failure Therapy?

Cardiovascular Research, Heart Failure Therapy
By Toni Bransford, M.D., FACC Senior Medical Director, Medical & Scientific Affairs, Cardiovascular Disease, Worldwide Clinical Trials,

The rate of disease progression is dependent both on the primary pathology and the activity of the compensatory processes, the most important of these being neural, endocrine, renal and morphological. Most of these chronic compensatory processes, such as activation of the renin-angiotensin-aldosterone system (RAAS) and sympathetic nervous system, are believed to be harmful, although the increase in natriuretic peptides is believed to be a beneficial compensatory response.

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At the Forefront of Drug Discovery and Development: Small to Midsize Biotech/Biopharma Companies are the Leaders of Innovation

small to midsize companies are leaders of innovation
By Peter Benton, COO and President of Worldwide,

Today, the innovators of drug discovery and development often are found in the smaller, biotech and biopharma companies around the world. In the past several years, more than 60% of new drugs approved originated at small and midsize companies – those outside the 30 largest pharmaceutical firms.

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“Stop the presses”: Biosimilar Development & Interchangeability

Interchangeability in Biosimilars, Biosimilar Drug Development
By William L Slone Ph.D. and Michael F. Murphy, M.D., Ph.D.,

Background In our recent blog, “Interchangeability in Biosimilars: Implications for Biosimilar Drug Development and Clinical Trials,” we reviewed the implications an interchangeable label might have on biosimilar development and usage. Since this publication, the U.S. Food & Drug Administration (FDA) has released a draft guidance titled “Considerations in Demonstrating Interchangeability With a Reference Product,” which provides recommendations for the standard that will be expected of an interchangeable biosimilar product. Herein, we will look at the highlights of the guidance and what it means for clinical trial design in programs seeking an interchangeable label.

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QTc Prolongation: The Threat of “Harmless” Medications and Their Impact on Patients & Drug Development

harmless medications and prolongation of the QT Interval
By Eteri Tsetskhladze, Senior Medical Director, Medical and Scientific Affairs, Worldwide Clinical Trials,

Life-threatening complications associated with the inappropriate use of “harmless” medications or supplements are increasingly being recognized as a concern to public health. Even when these products are not used in the treatment of cardiovascular conditions, they have the ability to delay cardiac re-polarization, manifested on an electrocardiogram (ECG) as prolongation of the QT interval.

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