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The Inflation Reduction Act (IRA) will introduce arbitrary changes in drug development as pharma companies are forced to work with complex new regulations that […]
BIO panels break down IRA’s challenges for drug makers and patients Read More »
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
FDA advisory committee endorses LEQEMBI Read More »
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
What’s at stake for Accelerated Approval? Read 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
FDA Commissioner Califf on COVID lessons, Accelerated Approval, and more Read More »
Intellectual property (IP) protections need reform but the current Congress may not have the consensus to achieve these changes, a panel of Capitol Hill
Congress may lack consensus needed for IP reform this year, BIO panelists say Read More »
“The policy environment is something that a lot of people seem to think is this separate, strange thing that has very little to do
Enhancing public health preparedness through policy and partnership Read More »
A new class of Alzheimer’s drugs will be available to patients on Medicare – but only if the medicine has received “traditional approval” and
Medicare confirms registry requirement for new class of Alzheimer’s drugs Read More »
On May 25, 2023, the Biotechnology Innovation Organization (BIO) and dozens of other biotechnology organizations sent a letter to congressional leaders calling for more
The U.S. Codex Office needs more funding – here’s why Read More »
The drug price controls in the Inflation Reduction Act (IRA) will have a far more serious impact on new drug development than previously expected,
IRA means 40% reduction in new drugs over 10 years, report finds Read More »
Two bills to create a healthy investment environment for biotech startups passed the House late May 30 with overwhelming bipartisan support. The legislation was
BIO-backed bills that would support startups passed by House Read More »
