5 lessons learned from COVID-19
The COVID-19 pandemic had a notably unprecedented impact on the world. Its lasting effects on society, economics, and healthcare have initiated a global discussion […]
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Federal Policy
House hearing puts focus on need for PBM transparency
A June 21 House hearing on health care costs put a sharp focus on the need for transparency to prevent pharmacy benefit managers (PBMs)
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BIO’s Phyllis Arthur testifies on need to reauthorize PAHPA, pass PASTEUR Act
On June 13, the House Energy & Commerce Health Subcommittee held a hearing, Legislative Solutions to Bolster Preparedness and Response for All Hazards and
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Merck and U.S. Chamber file lawsuits to block IRA’s drug price controls
Lawsuits filed in early June by Merck & Co. and the U.S. Chamber of Commerce seek to halt drug price controls established by the
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BIO panels break down IRA’s challenges for drug makers and patients
The Inflation Reduction Act (IRA) will introduce arbitrary changes in drug development as pharma companies are forced to work with complex new regulations that
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FDA advisory committee endorses LEQEMBI
On June 8, a Food and Drug Administration (FDA) advisory committee voted unanimously in favor of recommending traditional approval for LEQEMBI, the Alzheimer’s drug
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What’s at stake for Accelerated Approval?
The Accelerated Approval pathway has helped deliver groundbreaking treatments to patients—including for diseases like HIV. But lately, the pathway has faced increased pressure, threatening
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FDA Commissioner Califf on COVID lessons, Accelerated Approval, and more
Lessons from COVID, the Inflation Reduction Act (IRA), drug prices, drug shortages, Accelerated Approval and a lawsuit seeking to block use of an approved
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Congress may lack consensus needed for IP reform this year, BIO panelists say
Intellectual property (IP) protections need reform but the current Congress may not have the consensus to achieve these changes, a panel of Capitol Hill
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Enhancing public health preparedness through policy and partnership
“The policy environment is something that a lot of people seem to think is this separate, strange thing that has very little to do
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