Policy & Regulation


  • Robert F. Kennedy Jr.
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    Michael M. Santiago via Getty Images
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    RFK Jr.’s autism fixation hearkens back to his stance on vaccines

    The head of HHS is seeking the “root causes” of autism spectrum disorder through a large government research project.

    By May 9, 2025
  • FDA headquarters sign
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    Prasad’s FDA appointment pressures cell and gene therapy stocks

    A vocal opponent of his predecessor Peter Marks, Dr. Vinay Prasad will now lead the office tasked with reviewing some genetic medicines, adding more uncertainty to an already struggling field of research.

    By Ben Fidler • May 7, 2025
  • rare disease ribbon Explore the Trendline
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    Trendline

    Rare diseases

    As drug developers find promise in the rare diseases, deals and treatments are on the rise

    By PharmaVoice staff
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    With TV ads under threat, here’s how pharma can leverage social media

    RFK Jr.’s plan to ban TV advertising may shift more marketing attention to online platforms.

    By May 7, 2025
  • Joaquin Duato
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    Kevin Dietsch via Getty Images
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    On tariffs and pricing, Big Pharma CEOs are waiting out the storm while planning for the worst

    Chief executives at the largest drugmakers in the world are confident tariffs and pricing measures won’t be a major problem. But they’re still poised for change.

    By May 6, 2025
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    Is pharma ready to let go of animal testing?

    Regulators have signaled their willingness to embrace alternative tests and guide the industry in new directions.  

    By May 2, 2025
  • A wall bearing the Johnson & Johnson logo is seen outside of an office building.
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    Courtesy of Johnson & Johnson
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    J&J scores FDA OK for immune drug touted as future blockbuster

    The company has predicted that Imaavy — now approved for myasthenia gravis — could eventually earn more than $5 billion in annual sales at its peak.

    By Ned Pagliarulo • May 1, 2025
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    Q&A

    Can real-world evidence bear some of the burden left by NIH cuts? This CEO sees an opportunity.

    Turmoil at the NIH has led to handwringing among researchers and drugmakers who rely on public funding. 

    By May 1, 2025
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    Andrew Harnik via Getty Images
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    Is the FDA headed for a major reorganization?

    A leaked document revealed details about changes that could impact how the agency operates, but recent comments from FDA Commissioner Dr. Marty Makary have muddied the picture. 

    By April 30, 2025
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    US backlash against mRNA vaccines could hinder scientific progress

    U.S. health agencies are taking the fight to vaccine and mRNA research, which could have lasting repercussions on medical and scientific advancements.

    By April 29, 2025
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    Sarah Silbiger via Getty Images
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    FDA’s job cuts paint mixed picture for drugmakers’ R&D plans

    After a 20% cut to the FDA’s workforce, biotechs and pharmas are bracing for delays. But the impacts won’t be consistent.

    By April 28, 2025
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    What’s being cut at NIH

    A look at the government’s far-reaching rollback in research grants so far.

    By April 25, 2025
  • President Donald Trump speaks in the Oval Office of the White House on April 7, 2025.
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    Kevin Dietsch via Getty Images
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    Trump reveals pharma reform priorities in drug pricing executive order

    The order takes aim at fixing the IRA’s “pill penalty,” as well as PBM reform and other attempts to lower drug prices.  

    By April 23, 2025
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    How a scrapped Pfizer drug became a winner for SpringWorks

    SpringWorks Therapeutics and the Children’s Tumor Foundation salvaged a shelved asset for neurofibromatosis and got it over the regulatory finish line.

    By Alexandra Pecci • April 21, 2025
  • psilocybin lab
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    A big moment is coming for psychedelics

    Compass Pathways expects to publish the first phase 3 results from a large-scale, psilocybin drug trial by the end of this quarter.

    By April 18, 2025
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    Deep Dive

    HHS layoffs may be illegal, legal experts say

    The federal health department sidestepped normal procedures as it laid off 10,000 employees, according to sources. One union has already filed an internal complaint, while at least two law firms are exploring suits.

    By Rebecca Pifer • April 17, 2025
  • A sign spelling Novartis hangs on the side of a building.
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    Sedat Suna via Getty Images
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    Novartis scores NFL deal to tackle health outcomes

    The non-traditional marketing approach comes amid a potential crackdown on TV drug ads. 

    By April 17, 2025
  • UnitedHealthCare sign
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    Stephen Maturen via Getty Images
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    The fallout from UnitedHealth’s CEO slaying

    Brian Thompson’s murder has raised questions about the cost of U.S. healthcare, embroiling insurers, drugmakers and PBMs in a battle for the future of the industry.

    By PharmaVoice staff • April 15, 2025
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    ‘Chaos’ in the biotech market has dampened hopes of a rebound. What does that mean for dealmaking and IPOs?

    The biotech market is taking a beating amid Trump’s turbulent economic policies.

    By April 15, 2025
  • Tariff pharma
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    Pharma’s capital allocation could shift as tariffs threaten an already fragile profit model

    Major changes to the dynamics of the pharmaceutical ecosystem are making executive decisions even tougher.

    By April 14, 2025
  • pharma manufacturing concept
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    Pharma’s US manufacturing moment: Where companies are making the biggest moves

    The tariff war has prompted new calls to reshore manufacturing. Several large pharmas have already made the leap.

    By April 11, 2025
  • President Donald Trump displays a chart showcasing coming tariff rates at the White House on April 2, 2025.
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    Chip Somodevilla via Getty Images
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    Trump’s tariff tirade and sudden calm keep Big Pharma on its toes

    A wild ride in an escalating trade war has torn at Big Pharma’s shares while global markets flag in the back-and-forth winds.

    By April 10, 2025
  • A person looks through a pipette while working at a laboratory bench.
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    Kevin Frayer via Getty Images
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    US risks losing biotech edge to China, report warns

    “There will be a ChatGPT moment for biotechnology,” a bipartisan commission wrote in the new report, which calls for the U.S. to invest at least $15 billion into the sector over the next five years.

    By Ned Pagliarulo • April 9, 2025
  • Vials of Eisai and Biogen's new Alzheimer's drug Leqembi
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    Courtesy of Eisai
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    US vs. EU: When it comes to novel Alzheimer’s drugs, regulators can’t seem to agree

    The FDA is much more flexible in approving first-in-class drugs compared to European regulators.  

    By April 7, 2025
  • Dr. Mehmet Oz arrives for his confirmation hearing with the Senate Finance Committee in the Dirksen Senate Office Building on March 14, 2025 in Washington, D.C.
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    Anna Moneymaker / Staff via Getty Images
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    Dr. Oz confirmed to lead CMS

    Dr. Mehmet Oz, a physician and TV personality, will lead the agency during a turbulent time for federal health programs as the HHS lays off thousands of staffers and Republicans float potential cuts to Medicaid.

    By Emily Olsen • April 4, 2025
  • HHS staff cuts
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    Opinion

    Industry leaders react to HHS being ‘reduced to a shell’

    What healthcare watchdogs have said about the far-reaching job cuts this week.

    By Meagan Parrish and Amy Baxter • April 3, 2025