Policy & Regulation


  • A handful of syringes containing COVID-19 vaccine doses rest in a cardboard tray.
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    COVID’s remaining biotech contenders navigate a dwindling market

    With policy and funding evolving, companies are being forced to rethink strategies. 

    By Kelly Bilodeau • June 2, 2025
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    The MAHA agenda won’t include expanding GLP-1 coverage — for now

    Despite axing a Biden-era proposal for government coverage of obesity drugs, health officials have signaled a potential path forward.

    By June 2, 2025
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    Trendline

    Emerging biotech

    After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.  

    By PharmaVoice staff
  • President Donald Trump stands at podium with Robert F. Kennedy Jr. on his left side
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    Andrew Harnik via Getty Images
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    What’s next for Trump’s ‘most favored nation’ policy?

    HHS set drug price targets last week for pharma manufacturers, while lawmakers proposed new reforms.

    By May 27, 2025
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    The placebo effect: How a new FDA rule could pile more strain onto vaccine developers

    The proposed plan would require placebo testing for all new vaccines and could mean additional costs and time for R&D.

    By Alexandra Pecci • May 20, 2025
  • Donald Trump (C) speaks during a press conference in the Roosevelt Room of the White House with health agency leaders on either side
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    Andrew Harnik via Getty Images
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    With the third round of Medicare price negotiations on the way, here’s how the policy is shifting

    HHS issued guidance for the third cycle, teeing up another 15 drugs to be selected by early next year.  

    By May 19, 2025
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    Tracking a moving target: Drugmakers brace for a looming tariff impact

    With policies in flux, companies seek to be proactive and understand their supply chain.

    By Kelly Bilodeau • May 19, 2025
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    Andrew Harnik/ via Getty Images
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    Trump’s ‘most favored nation’ policy is back. Here’s why it failed the first time.

    The controversial plan aims to lower drug prices and will surely trigger another fight with pharma.

    By May 14, 2025
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    FDA’s future in MAHA hands: How leadership is changing the agency’s trajectory

    Who’s in, who’s out and which key positions are still left to be filled in an agency upended.

    By Alexandra Pecci • May 13, 2025
  • Robert F. Kennedy Jr.
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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
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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
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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
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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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    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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    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
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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
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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