Author Archives: Jill Wechsler

Spending Rises on Prescription Drugs, Despite Overall Slowdown in Healthcare Outlays

More new medicines came to market in 2013, and fewer blockbuster drugs lost patent protection, trends that federal analysts say led to more rapid growth in outlays for prescription drugs in 2013. Retail prescription drug spending rose 2.5% to reach $271 billion a year ago, much faster than the low growth rate of 0.5% in […]
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Breakthrough Drug Initiative Success Creates Manufacturing Challenges

The breakthrough drug initiative has accelerated the development and approval of highly effective therapies, enabling important new medicines to reach patients sooner, according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years for several critical conditions in addition to cancer, […]
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Randomized Trials Key to Determining Effectiveness of Ebola Therapies and Vaccines

US researchers and regulators continue to support the use of randomized clinical trials to test potential treatments and vaccines to combat the Ebola virus, despite objections that this approach is unethical and unfair to vulnerable populations. Anthony Fauci, director of the National Institute of Allergy & Infectious Diseases (NIAID), articulated the case for “gold-standard” randomized […]
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Breakthrough Therapy Program Exceeds FDA’s Expectations

The two-year-old initiative to accelerate the development and approval of highly effective drugs and biologics has enabled a number of important new medicines to reach patients sooner,  according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years, for several critical […]
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CMS Struggles to Fix Sunshine System

The feds have “a long way to go” to get the Open Payments system operating effectively and user friendly, according to officials in charge of the financial disclosure program. “Sunshine” went live September 30, 2014, as scheduled, but incomplete and contradictory data listings made it necessary to withhold nearly one-third of financial transaction reports from […]
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