March 25th 2024
J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with PAH.
February 5th 2024
FDA Advisory Committee Backs Use of Onpattro in Heart Failure Indication
September 16th 2023Even though committee members voted in support of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, there were questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.
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New Heart Failure Med Will be Priced 'Competitively'
May 30th 2023Inpefa (sotagliflozin) is in the SGLT inhibitor class recommended as first-line treatment for heart failure by the American Heart Association and other groups. Jardiance (empaglifozin), a competitor in that class, has a list price of $570.48 for a month's supply.
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FDA Accepts sBLA for Evkeeza for Children with Rare High Cholesterol
November 30th 2022If approved, Evkeeza would be the first treatment to help children as young as 5 years old control high LDL cholesterol caused by homozygous familial hypercholesterolemia. The FDA target action date is March 30, 2023.
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CMS Coverage Decision of Pulmonary Embolectomy Criticized
November 19th 2021JAMA Internal Medicine editor and a UCSF colleague wrote in a New England Journ of Medicine opinion piece that the decision highlights the need to establish a new requirement that would make coverage decisions contingent on evidence of benefit for Medicare population.
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