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PhRMA SVP Robert Zirkelbach told me in a conversation yesterday that the next prescription drug user fee deal — to be known as PDUFA VIII — has cleared the White House’s Office of Management and Budget, paving the way for the public release of the goals letter. That letter will explain exactly what's in this next deal, and has to be codified by Congress by Sept. 30, 2027. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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President Donald Trump signs an executive order for tariffs, April 2, 2025 (Andrew Leyden/NurPhoto via AP Images) |
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by Anna Brown
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Over the past 16 months, the Trump administration’s pharma tariffs have loomed large over the industry. While the first wave of these levies was scheduled... | |
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by Max Bayer
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The US has followed through on its $600 million funding commitment to Gavi, a global vaccine consortium, after the funds were held in limbo for... | |
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by Zachary Brennan
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HHS' Health Resources and Services Administration unveiled details of a revised 340B rebate pilot, which will let some drug manufacturers deny rebates for a small... | |
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by Zachary Brennan
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Capricor Therapeutics failed to win the backing of an FDA advisory panel for deramiocel, a therapy intended to slow the rate of decline in cardiac... | |
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by Max Bayer
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A majority of FDA advisors backed Replimune’s advanced melanoma treatment, voting in favor of the product’s efficacy and the data produced in its study, marking... | |
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CDC Director nominee Erica Schwartz testifies during her confirmation hearing on July 15, 2026 (Mariam Zuhaib/AP Images) |
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by Nicole DeFeudis
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The Trump administration’s nominee to be the next CDC director has won the support of a key Senate committee, sending her nomination to the full... | |
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Neil Vasan, former acting chair for the FDA's Oncologic Drugs Advisory Committee (NYU) |
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by Zachary Brennan
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Neil Vasan, acting chair of the FDA's Oncologic Drugs Advisory Committee, told Endpoints Newsthat he's stepped down from the committee. He's participated in 22... | |
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