Why state drug importation pilot programs don’t work
By Nick McGee | February 8, 2019
Across the country, some states are recirculating failed proposals that would establish state-run prescription medicine importation schemes. Such proposals would allow medicines from foreign...
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Putting 2018 medicine approvals in context
By Andrew Powaleny | January 23, 2019
Last year, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved a record number of novel new medicines with 59 new molecular entities (NMEs). While...
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FDA needs best and brightest to advance a new era of medicine with America’s biopharmaceutical companies
By Richard Moscicki, M.D. | October 16, 2018
The U.S Food and Drug Administration (FDA) plays a critical role in protecting and promoting the health of all Americans. Every day, the FDA does important work to ensure the safety, efficacy and...
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Balancing innovation and competition in the biologics marketplace
By David Korn | October 11, 2018
Last month, I presented at the U.S. Food and Drug Administration’s (FDA) Public Hearing on Facilitating Competition and Innovation in the Biological Products Marketplace. The hearing was part of...
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New analysis shows that more medicines worldwide are available to U.S. patients
By Kevin Haninger | June 5, 2018
In the past year, we have seen revolutionary new treatments become available to patients in the United States for cancer and other debilitating diseases. A new analysis puts in perspective the...
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Spending on medicines grew less than one percent in 2017
By Holly Campbell | April 19, 2018
Last year, a record number of new treatments and cures that are transforming care for patients fighting debilitating diseases like cancer, hepatitis C, high cholesterol and more were approved by...
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Rare Disease Day: Unmet need inspires innovation
By Andrew Powaleny | February 28, 2018
Today, we celebrate Rare Disease Day to both reflect on the progress made toward conquering rare diseases and recognize the continued unmet medical need for these devastating, complex conditions.
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Innovation comes in many forms, including new and expanded uses of existing medicines
By Emma Van Hook | January 29, 2018
2017 was a record-breaking year for new drug approvals, with the U.S. Food and Drug Administration (FDA) approving 56 new drugs and biologics. But the innovation did not stop there. As the FDA...
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ICYMI: Why 2017 medicine approvals matter
By Andrew Powaleny | January 12, 2018
This week, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released its 2017 New Drug Therapy Approvals report. Last year marked an extraordinary...
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New surveys find payers and providers want more data from biopharmaceutical companies
By Joe Vandigo | December 6, 2017
Both payers and providers are interested in additional information from biopharmaceutical companies about prescription medicines – including information about pipeline medicines and unapproved...
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