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Speedy Drug Approvals Have Become the Rule, Not the Exception
A majority of recent drug development has been in therapies that qualify for at least one special approval pathway that Congress has passed over the past few decades for important drugs that treat life-threatening or rare diseases.
Congress has over the past few decades passed a series of special approval pathways for important drugs that treat life-threatening or rare diseases. This week, a new bill introduced in the House could add 2 more.
You might expect these existing special programs to represent a small fraction of new and unusual drugs. But data from the FDA show that a majority of recent drug development has been in therapies that qualify for at least one of these programs. About a third of recently approved drugs qualify for 2 more of 5 special approval programs.
A great interactive graphic mapping research by Aaron Kesselheim and Jonathan Darrow on the website of the New England Journal of Medicine allows you to slice the data a few different ways.
Read more at The New York Times: http://nyti.ms/1dCK1D5
Oncology Onward: A Conversation With Dr Shereef Elnahal, Under Secretary for Health
April 20th 2023Shereef Elnahal, MD, MBA, under secretary for health at the Veterans Health Administration (VHA), sat for a conversation with our hosts Emeline Aviki, MD, MBA, Memorial Sloan Kettering Cancer Center, and Stephen Schleicher, MD, MBA, Tennessee Oncology, that covered the cancer footprint of the VHA.
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Muscle-Directed Therapy Apitegromab Meets Primary End Point in Phase 3 SAPPHIRE Trial of SMA
October 17th 2024Patients aged 2-21 receiving apitegromab showed clinically meaningful motor function improvements, with a favorable safety profile consistent with long-term data, as Scholar Rock prepares for US and EU regulatory submissions in Q1 2025.
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