Policy & Regulation


  • MAHA
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    The end of MAHA?; Inovio’s big FDA win

    American voters turned their noses up at MAHA-aligned candidates this week; Inovio won a breakthrough nod for a DNA-based therapy.

    By PharmaVoice Staff • Nov. 6, 2026
  • Vivek Ramaswamy embraces a woman onstage at an Ohio Republican election-night event in Columbus, Ohio.
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    Ramaswamy’s biotech baggage haunted his political run

    A pivotal Alzheimer’s trial tied to Vivek Ramaswamy’s political rise is a tale of failed endpoints.

    By Sy Mukherjee • Nov. 5, 2026
  • Trendline

    Artificial intelligence & machine learning

    After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.

    By PharmaVoice staff
  • Abdul El-Sayed
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    The Democrats are coming. Here’s how they want to change pharma and healthcare.

    This week’s slate of Democratic winners have set their sights on expanding healthcare, removing RFK Jr. from HHS and pulling back the curtain on Trump’s secretive pharma deals.

    By • Nov. 5, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    A push for speedier drug approvals doesn’t promise smooth market sailing

    Investors and payers sometimes balk at drugs approved on an accelerated pathway. Here’s how pharma can de-risk these medications while they’re still in development.

    By Alexandra Pecci • Nov. 4, 2026
  • Eric Cantor, wearing glasses and a dark suit, gestures while speaking at a lectern with microphones.
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    Pharma has friends in both parties this midterm season. Neither is offering a free pass.

    As the industry donates and lobbies in both political directions, ongoing drug policy issues and a new head of PhRMA could complicate its traditional campaign playbook.

    By Sy Mukherjee • Oct. 29, 2026
  • Prescription pills spilling out of the bottle on a background made of $20 bills.
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    Most new drugs are still too costly at launch, ICER says

    A new analysis from the non-profit group found that net launch prices for new medicines spiked significantly between 2022 and 2025, and the majority were well above its cost-effectiveness guidelines.  

    By Jonathan Gardner • Oct. 22, 2026
  • Illustration of a prescription pill bottle and pills forming a rising cost graph.
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    Pharma gift giving linked to writing more prescriptions — but less appropriate prescribing

    The line between educating healthcare professionals and wooing them can still be fuzzy, which is impacting what doctors prescribe, according to a new analysis.

    By Alexandra Pecci • Oct. 20, 2026
  • A magnifying glass enlarges the U.S. Food and Drug Administration website on a computer screen.
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    FDA ‘reset’ continues with new plan for reviewing rare disease drugs

    A revamped regulatory framework may give investors less of a “guessing game” as they weigh chances for drug approvals, one analyst said.

    By Kristin Jensen • Oct. 16, 2026
  • Illustration of a man in a black coat offering pills for sale.
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    Lilly is fighting a black market for its new obesity drug even before it launches

    The large pharma’s promising new candidate retatrutide is still in the clinic. But Lilly is already fighting a web of illicit sellers for the drug online.

    By Kelly Bilodeau • Oct. 12, 2026
  • HHS
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    HHS’ need for R&D speed; weird GLP-1 side effects

    HHS is cranking up its efforts to accelerate drug development; more reports are emerging about off target effects of obesity drugs. 

    By PharmaVoice Staff • Oct. 9, 2026
  • A magnifying glass enlarges the U.S. Food and Drug Administration website on a computer screen.
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    5 key facts about the FDA expedited IND pilot program

    The program, part of Operation TrialBlazer, aims to speed early research and help the U.S. bring trials back from overseas.

    By Kelly Bilodeau • Oct. 7, 2026
  • Conference
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    Top pharma industry conferences in 2027

    Where pharma and biotech leaders will converge to network, share ideas and potentially strike deals.

    By • Oct. 6, 2026
  • Wall Street buildings
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    Basecamp raises $140M before the clinic; J&J and Compass’ potential rivalry

    Some of the biggest news and trends captured in PharmaVoice’s newsletter this week. Sign up here to receive the newsletter daily. Another big AI haul Investors are still lining up to back AI drug developers before their candidates reach human trials. Basecamp Research...

    By PharmaVoice Staff • Sept. 25, 2026
  • FDA Commissioner nominee Heidi Overton testifies before Senate committee.
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    Tasos Katopodis via Getty Images
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    Where does FDA nominee Overton stand on vaccines and other key pharma issues?

    Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on vaccine-related decisions and work to speed early drug R&D.

    By Jonathan Gardner • Sept. 24, 2026
  • President Donald Trump holds up a chart comparing drug prices and Medicare Part D costs during a healthcare affordability event in the Oval Office.
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    Kevin Dietsch via Getty Images
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    A hidden tradeoff in Trump’s MFN drug deals

    The government has announced pricing agreements with 26 pharma companies. But the deals could stymie other plans to lower the country’s drug spend.

    By Kelly Bilodeau • Sept. 21, 2026
  • women's health
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    Where female participation in clinical trials has caught up — and where gaps remain

    Getting more women into drug R&D remains critical for boosting health outcomes. But in some disease areas, pharma is still falling behind.

    By Kelly Bilodeau • Sept. 16, 2026
  • A sign outside the FDA’s headquarters in White Oak, Maryland.
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    Westy72 via Getty Images
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    PDUFA reauthorization offers a chance at clinical trial reforms. Will the US take it?

    The reauthorization could give Congress the opportunity to help streamline clinical trials and accelerate drug research.

    By Kelly Bilodeau • Sept. 14, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA gains ‘continuity’ as Mikhail, Davis named permanent CBER, CDER leaders

    After almost two years of turnover in the FDA’s top ranks, the new appointments should help ease concerns about more turmoil ahead, one analyst said. 

    By Kristin Jensen • Sept. 9, 2026
  • A tablet displays the Kalshi prediction-markets app.
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    Prediction markets are putting a price on pharma’s secrets. Here’s what companies need to know.

    As betting expands into clinical trial outcomes, drugmakers may need to look beyond employees and scrutinize outside partners with access to sensitive information.

    By Sy Mukherjee • Sept. 8, 2026
  • Gilead sign
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    Gilead’s growing HIV franchise; cell therapy licensing deals plummet

    The FDA recently OK'd Gilead's novel HIV combo med, and cell therapy deals have fallen dramatically in two years.

    By PharmaVoice Staff • Sept. 4, 2026
  • Measles
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    As measles outbreaks soar, where does drug R&D stand?

    More than 25 years after it was declared eliminated, measles has surged back. But drug R&D is still in early stages and up against a tense market environment.

    By Alexandra Pecci • Sept. 4, 2026
  • An illustration of B cells producing antibodies
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    Autoimmune CAR-T faces tough questions after Novartis, Bristol Myers study halts

    Wall Street analysts believe that a more cautious approach to manufacturing, study enrollment and side effect management could help developers avoid future safety hazards.

    By Jonathan Gardner • Sept. 3, 2026
  • Rep. John Moolenaar sits in a congressional hearing room wearing a dark suit and plaid tie.
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    China’s clinical trial boom under scrutiny after 3 deaths come to light

    Two House Republicans are asking the FDA to increase oversight of China-generated clinical data after three trial deaths are reported.

    By Kelly Bilodeau • Sept. 3, 2026
  • President Trump holding up an executive order on vaccines.
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    Anna Moneymaker via Getty Images
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    Trump signs order seeking to upend childhood vaccine schedule

    The executive order — which wasn’t accompanied by any new scientific evidence — aims to split the MMR vaccine into three separate shots and revives the administration’s attempt to slim down the immunization schedule.

    By Delilah Alvarado • Aug. 11, 2026
  • tariffs
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    Large pharmas skirt tariffs; BMS’ dealmaking drought

    Big Pharmas won't get hit new levies on branded drugs; and aside from the megamerger rumors, BMS has had a relatively quiet year for M&A.

    By PharmaVoice Staff • Aug. 7, 2026