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Lilly plans new $4.5B manufacturing investment in Indiana
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Amgen, AbbVie say IRA negotiations impacted Q1 sales
At least two drugmakers say they’re feeling the impact of the Inflation Reduction Act, after the first drug prices negotiated under the law took effect in January.
Amgen and AbbVie reported in their first-quarter earnings …
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STAT+: Administration report on most favored nation drug pricing raises new details — and questions
WASHINGTON — The Trump administration on Tuesday released the most detailed look to date at its drug pricing policy and its purported impact, claiming huge future savings from the program.
The report, from the administration’s own Council of Economic Advisers, lays out the definition of “most-favored nation” pricing. That’s the definition pharmaceutical giants agreed to in their confidential deals with the administration, a White House spokesperson told STAT in an email. The most-favored nation pricing calculation represents a key underpinning of one of the White House’s top election-year talking points — though many key details of the deals remain private, and their ultimate impacts for consumers uncertain.
The analysis estimated the drug companies’ pledge to offer all new drugs at most-favored nation pricing would save the U.S. $529 billion over the coming decade — though the projection comes with big caveats.
WASHINGTON — The Trump administration on Tuesday released the most detailed look to date at its drug pricing policy and its purported impact, claiming huge future savings from the program.
The report, from the administration’s own Council of Economic Advisers, lays out the definition of “most-favored nation” pricing. That’s the definition pharmaceutical giants agreed to in their confidential deals with the administration, a White House spokesperson told STAT in an email. The most-favored nation pricing calculation represents a key underpinning of one of the White House’s top election-year talking points — though many key details of the deals remain private, and their ultimate impacts for consumers uncertain.
The analysis estimated the drug companies’ pledge to offer all new drugs at most-favored nation pricing would save the U.S. $529 billion over the coming decade — though the projection comes with big caveats.
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STAT+: Sanofi asks to pull diabetes drug out of FDA voucher program after political appointee interfered with review
WASHINGTON — Sanofi has asked the Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of Commissioner Marty Makary’s new speedy drug review program.
The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth Høeg disagreed with a staff decision to approve the drug, according to sources familiar with the dispute who requested anonymity due to fear of reprisal. The agency has missed its goal date of April 21 to deliver a decision to Sanofi.
Such decisions are typically made by career scientists. It’s rare for a center director to become involved in scientific review of a single drug, and particularly a political appointee like Høeg. Makary recently told CNBC that he stands behind review teams, and that “disaster” occurs whenever political leaders overrule scientific staff.
WASHINGTON — Sanofi has asked the Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of Commissioner Marty Makary’s new speedy drug review program.
The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth Høeg disagreed with a staff decision to approve the drug, according to sources familiar with the dispute who requested anonymity due to fear of reprisal. The agency has missed its goal date of April 21 to deliver a decision to Sanofi.
Such decisions are typically made by career scientists. It’s rare for a center director to become involved in scientific review of a single drug, and particularly a political appointee like Høeg. Makary recently told CNBC that he stands behind review teams, and that “disaster” occurs whenever political leaders overrule scientific staff.
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