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McClellan seeks to lead charge for healthcare reform
WASHINGTON, D.C.-Instead of going back to academia, former FDA Commissioner and Medicare Administrator Mark McClellan, MD, is setting up his own shop to tackle health reform and drug safety more actively. Dr. McClellan will head the Engelberg Center for Health Care Reform at the Brookings Institution, starting with $20 million in funding from Alfred Engelberg and Leonard Schaeffer.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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Extending the Capabilities of the EHR Through Automation
August 2nd 2023Welcome back to another episode of "Tuning In to the C-Suite," where Briana Contreras, an editor of Managed Healthcare Executive, had the pleasure of chatting with Cindy Gaines, chief clinical transformation officer at Lumeon.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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Drugs to Watch: Mental Health Conditions
April 11th 2024The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.
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