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Sovaldi, Harvoni, And Why It’s Different This Time
Battle Lines Drawn Over Biosimilar Application And Patent Disclosure Process
Reminder: Health Affairs Briefing: Specialty Pharmaceuticals
Rescue Me: The Challenge Of Compassionate Use In The Social Media Era
The Role Of Black Box Warnings In Safe Prescribing Practices
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Sovaldi, Harvoni, And Why It’s Different This Time
With the Food and Drug Administration (FDA)’s approval of Harvoni, the successor to Gilead Science’s Sovaldi, the alarm bells have officially rung on breakthrough hepatitis C treatments. One can’t open a newspaper or scan a Twitter feed without stumbling...
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Fri, Nov 11 2014 11:18 AM
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Battle Lines Drawn Over Biosimilar Application And Patent Disclosure Process
The Biosimilars Price Competition and Innovation Act of 2009 (BPCIA) introduced a long-awaited, and highly-supported, abbreviated route to market for “biosimilar” and “interchangeable” biologic products. The goal was to create incentives for development...
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Mon, Nov 11 2014 6:00 AM
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Reminder: Health Affairs Briefing: Specialty Pharmaceuticals
We live in an era of specialty pharmaceuticals -- drugs typically used to treat chronic, serious or life threatening conditions such as cancer, rheumatoid arthritis, growth hormone deficiency, and multiple sclerosis. Their cost is often much higher than...
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Fri, Oct 10 2014 8:48 AM
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Rescue Me: The Challenge Of Compassionate Use In The Social Media Era
The Development of Brincidofovir and its Possible Use to Treat Josh Hardy Last March 4, seven-year old Josh Hardy lay critically ill in the intensive care unit at St Jude Children’s Hospital in Memphis, Tennessee with a life-threatening adenovirus infection...
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Wed, Aug 08 2014 9:29 AM
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The Role Of Black Box Warnings In Safe Prescribing Practices
In the Health Affairs article, “ Era of Faster Drug Approval Has Also Seen Increased Black-Box Warnings and Market Withdrawals ,” published in the August issue, Cassie Frank and coauthors compare the number of approved prescription drugs that received...
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Wed, Aug 08 2014 12:17 PM
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Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework
Editor's note: In addition to Meaghan George, Sara Bencic and Darshak Sanghavi also coauthored this post. Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development...
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Thu, Jul 07 2014 12:12 PM
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Bringing Patients Into Health System Change
Editor's note: For more on the attitudes of Americans toward medical care and empowering patients to be active participants in their own care, see the February issue of Health Affairs , " New Era Of Patient Engagement ." The attention now...
Published
Tue, Feb 02 2013 11:57 AM
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Drug Shortages: Why A Government Stockpile Falls Short As A Solution
Planned and unplanned disruptions in production of drugs are behind an overwhelming share of drug shortages. Stockpiling the finished product has been proposed as a solution for preventing future shortages. The general idea is that the federal government...
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Wed, May 05 2012 12:53 PM
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Adolescents And Young Adults: Bringing A Neglected Group Into Cancer Research
“A child is not a small adult,” but an adolescent is not a large child. Adult oncologists, reluctant to care for cancer patients under the age of 16, believe that adolescent and young adult (AYA) cancer patients should be within their purview. We...
Published
Fri, Jan 01 2012 9:16 AM
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Narrative Matters: Drug Company Payments To Physicians
In the December Health Affairs Narrative Matters essay, multiple sclerosis patient Maran Wolston describes how she lost trust in her physician when she found out he was receiving payments from drug companies. Wolston says she was fortunate to be able...
Published
Tue, Dec 12 2011 9:09 AM
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