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4 February, 2025 |
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A new executive order from President Trump mandates that anytime a federal agency (like the FDA) promulgates a new rule, regulation or guidance, it must identify at least 10 existing ones to repeal. That could significantly curtail the agency's ability to issue guidance for the pharma industry on various topics from clinical trials to new endpoints. When the first Trump administration required two existing regulations to be
pulled for every new one promulgated, and guidance documents were also included in the mix, the FDA had to reconsider when to issue guidance documents in lieu of regulations. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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by Drew Armstrong
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Robert F. Kennedy Jr. is headed for Senate confirmation following Tuesday’s committee vote and a statement of support from the GOP’s biggest skeptic. But it’s still very, very unclear which Kennedy Americans are likely to end up with — the anti-vaccine crusader, or a more moderate version who made (vague) promises last week that he would let independent science lead. In the space of just a few minutes on Tuesday, that question got even muddier. Just ahead of the Senate Finance vote, Trump posted on social media that “20 years ago, Autism in children was 1 in 10,000. NOW IT’S 1 in 34. WOW!
Something’s really wrong. We need BOBBY!!!” |
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Albert Bourla, Pfizer CEO (Eric Risberg/AP Images) |
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by Max Bayer
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Pfizer's next deals are likely to be longer-term efforts to reload its R&D work rather than big-ticket, late-stage assets, the company's top executives said Tuesday. “Looking forward, we are looking at more strategic opportunities right now, which will enhance the pipeline in areas that we would like to play, rather than near-term revenues,” CEO Albert Bourla told
investors Tuesday. The company has about $10 billion to $15 billion it could put toward M&A this year, according to CFO Dave Denton. He previously guided that while there’s always “a little flexibility to do BD,” large transactions would likely be kicked to 2026 or beyond. Pfizer has made de-levering a priority, with billions in cost cuts initiated and executed, and billions more raised by
selling off stakes in Haleon, a consumer health wing co-run with GSK. |
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Rob Davis, Merck CEO (Jeenah Moon/Bloomberg via Getty Images) |
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by Nicole DeFeudis
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Despite uncertainty around HPV vaccine sales in China, Merck CEO Rob Davis said he’s confident the company can “deliver strong growth” and navigate Keytruda’s impending patent cliff. Davis called the Chinese market challenges a “short-term headwind” for Merck. Lower-than-expected demand for Gardasil led the company to
pause shipments to China on Tuesday and drove its stock MRK down 10%. But when it comes to long-term sales expectations, Davis said Merck was “never counting on Gardasil as a growth driver.” “We always had an expectation that eventually it would start to plateau,” he said during Merck’s fourth-quarter earnings call on Tuesday. Davis touted higher demand for Gardasil outside of China, and said “overall business
is healthy and growing.” |
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by Nicole DeFeudis
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Johnson & Johnson has asked a federal district court to expedite its decision in a case over the company’s proposed 340B rebate model, citing upcoming deadlines for complying with the Inflation Reduction Act's drug pricing provisions. The company has until Sept. 1 to submit a written plan to CMS with its "intended
procedures" for meeting its obligations under the IRA's drug price negotiation program. But J&J said it faces "significant obstacles" to complying with a key requirement: preventing duplicate discounts under the IRA and 340B. The lawsuit stems from the federal government's rejection of J&J's proposed rebate model, which the company says would help curb duplicate discounts and reduce fraud and abuse within the 340B program. J&J on Monday asked the US District Court for the District of Columbia for a ruling by July 1. |
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