Policy & Regulation


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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
  • 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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    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
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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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    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
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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
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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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    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
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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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    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
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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
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    With government health info in limbo, drugmakers lose credible sources

    The lack of clear communication from the government could spark wide-ranging issues in pharma — from sowing confusion about clinical trial design to further eroding public trust.

    By Alexandra Pecci • April 1, 2025
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    FDA’s ‘mixed signals’ on diversity have entangled clinical trials. Here’s how pharma can push ahead.

    The agency is still unclear about where it will stand on clinical trial diversity, but companies are looking for answers and leaning toward good science.

    By March 28, 2025
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    HHS announces sweeping reorganization, including cuts of 10K workers

    Along with shrinking the HHS’ workforce further, the reorganization announced Thursday will cut the department from 28 divisions to 15, and close five regional offices.

    By Rebecca Pifer • March 27, 2025
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    Rx-to-OTC rule gets pushed back — again

    A delay of the prescription-to-OTC rule signals health agencies’ ongoing reluctance to implement new regulations.

    By March 26, 2025
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    Lilly, Novo expand DTC reach of obesity meds after compound win

    The FDA delisted semaglutide and tirzepatide from its shortage list, putting an end to copycat GLP-1s.

    By March 24, 2025
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    How pharma could feel the pain of a recession

    Pharma has long been considered “recession proof,” but an economic downturn could still hurt the industry in numerous ways.

    By March 21, 2025
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    Vaccine makers face mRNA backlash as states seek further restrictions

    A handful of states are targeting the technology at the same time the Trump administration is cutting research funding and revoking vaccine contracts.

    By March 19, 2025
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    The key factors shaping China’s biopharma boom

    Chinese companies are involved in one-fifth of pharma’s clinical development programs, but trade wars and regulatory hurdles could stymie dealmaking.

    By Alexandra Pecci • March 19, 2025
  • Senator Elizabeth Warren speaks during a legislative hearing, holding her handout to the side. A sign in front of her reads "Ms. Warren."
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    Lawmakers tease out pharma’s influence over RFK Jr. through probe into Mar-a-Lago meetings

    HHS head Robert F. Kennedy Jr. has long been an opponent of pharma influence in government. U.S. lawmakers are asking whether unofficial Mar-a-Lago meetings point to a change of heart.

    By March 13, 2025
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    IRA reforms, including a small molecule fix, could be on the table. Will Trump and the GOP make the leap?

    Industry insiders are pushing to fix the small molecule ‘penalty’ by setting their hopes on a Republican majority.

    By March 12, 2025
  • Colorful medical pills cover Benjamin Franklin's face on one hundred american dollar bill.
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    Pricing transparency is in the spotlight — and that could be good news for drugmakers

    An opaque system of rebates and discounts makes understanding a drug’s true price near impossible, even for experts. Can efforts to bring transparency into that system now pan out?

    By March 11, 2025
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    As tariffs loom over pharma manufacturing, a reshoring effort is underway — but not without challenges

    Experts say cost and other barriers present challenges to returning to U.S. shores.

    By Kelly Bilodeau • March 10, 2025