Policy & Regulation


  • Pfizer Trump
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    Win McNamee via Getty Images
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    Tariffs, pricing, backroom deals — how pharma can navigate wildly shifting policies

    Gaming out new regulations and various potential outcomes will help keep companies on more solid footing.

    By Kelly Bilodeau • Nov. 3, 2025
  • President Donald Trump speaks to reporters at the White House on Oct. 5, 2025, in Washington, D.C.
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    Tasos Katopodis via Getty Images
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    How Trump’s do-or-die agenda is impacting Big Pharma’s CEO chatter

    Among tariffs, pricing policies and ongoing negotiations, pharma leaders can’t help but address their dealings with the Trump administration in third-quarter earnings reports.

    By Oct. 30, 2025
  • 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
  • Boston
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    Massachusetts biotech hub is limping amid layoffs and low investment

    The state’s difficulties in the last year are indicative of wider industry problems during a time of market trepidation, as optimism gives way to resilience.

    By Oct. 23, 2025
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    Why a treatment older than the FDA is getting new regulatory scrutiny

    MAHA-aligned patients and providers are pushing back to ensure access to an animal-derived thyroid hormone treatment.

    By Kelly Bilodeau • Oct. 20, 2025
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    Pregnant women, long excluded from drug trials, are back in the spotlight

    The White House has raised concerns around women’s health, but R&D on pregnant and breastfeeding women is still lacking.

    By Oct. 17, 2025
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    Ultra-rare diseases got a boost from recent FDA approval signalling more regulatory flexibility

    Stealth BioTherapeutics’ FDA win could help build momentum in the broader rare disease space.

    By Alexandra Pecci • Oct. 15, 2025
  • A photo of FDA CBER Director Peter Marks delivering remarks at a public workshop on March 3, 2020.
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    Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
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    Dr. Peter Marks, former top FDA vaccine official, joins Eli Lilly

    Six months after his abrupt resignation as CBER director, Marks has been hired to run discovery and infectious disease work at the big Indianapolis drugmaker.

    By Jonathan Gardner • Oct. 8, 2025
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    As setbacks plague other companies, MindMed becomes a front-runner in the psychedelics race

    Challenges faced by other drugmakers have reinforced, rather than discouraged, MindMed’s approach to psychedelic drug R&D for anxiety and other disorders.

    By Alexandra Pecci • Oct. 7, 2025
  • Trump Pfizer
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    Win McNamee via Getty Images
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    Trump administration could lower drug prices by making other nations pay more

    The Trump administration often touts its efforts to lower prices in the U.S. by matching what other countries pay, but there’s more to this policy story.

    By Kelly Bilodeau • Oct. 6, 2025
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    AstraZeneca’s at-home flu vaccine is a breakthrough that could pave the way for others

    FluMist Home could be a test case for at-home vaccines against a backdrop of challenging regulatory shifts.

    By Alexandra Pecci • Oct. 1, 2025
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    Top pharma industry conferences in 2026

    Where pharma leaders will converge, discuss and navigate the industry’s shifting landscape in 2026.

    By Oct. 1, 2025
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    Is pharma’s IRA pricing battle running out of steam?

    Despite recent court losses, the legal tides could still turn in the industry’s favor.

    By Sept. 26, 2025
  • Retro microphones for press conference or interview and old TV on table front gradient aquamarine background
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    With DTC ads under fire, pharma companies need to pivot

    An executive order from HHS doesn’t prohibit direct outreach to consumers, but drugmakers will need to rethink their outreach strategies.

    By Kelly Bilodeau • Sept. 22, 2025
  • FDA sign
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    3 FDA approval firsts that could be around the corner

    Several market-altering decisions are on the agency’s docket for the rest of 2025.

    By Sept. 19, 2025
  • A person in a blue sit sits behind a desk at a hearing.
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    Andrew Harnik via Getty Images
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    At Senate hearing, lawmakers express dissatisfaction with RFK Jr.’s vaccine moves

    Robert F. Kennedy Jr. faced criticism Thursday even from Republican lawmakers over changes to federal vaccine policy as well as a leadership crisis at the CDC.

    By Delilah Alvarado , Jonathan Gardner • Sept. 5, 2025
  • Europe
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    International appeal: Europe and UK lure US scientists with financial incentives

    With slashed budgets and decimated research programs, American scientists are increasingly looking for career opportunities abroad.

    By Alexandra Pecci • Sept. 4, 2025
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    Why drugmakers may need to borrow from quantum theory to confront tariff and pricing threats

    With so many unknowns surrounding regulatory and policy shifts, pharma companies might need to consider fundamental changes to how they operate, a Deloitte analyst said.

    By Sept. 3, 2025
  • Boxes of COVID-19 vaccines from Pfizer and Moderna sit side by side.
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    Joe Raedle via Getty Images
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    FDA approves updated COVID boosters, but narrows use

    In a post on X, HHS Secretary Robert F. Kennedy said the FDA has cleared vaccines from Pfizer, Moderna and Novavax for use in "high risk" individuals.

    By Delilah Alvarado • Updated Aug. 27, 2025
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    Why an FDA decision for a new drug could ripple through the ultra-rare disease space

    All eyes are on Stealth BioTherapeutics as it awaits a long-delayed approval for its first-in-class treatment for Barth syndrome.

    By Alexandra Pecci • Aug. 26, 2025
  • man in a dark blue suit speaks in the oval office
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    Anna Moneymaker via Getty Images
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    FDA’s new accelerated pathway could open pharma up to risks, as well as benefits

    Faster review times will leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty in the drug approval process.

    By Amy Baxter • Aug. 25, 2025
  • Robert F. Kennedy Jr. in a blue stripe suit points while speaking
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    Andrew Harnik via Getty Images
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    MAHA leaders may take aim at pharma DTC advertising

    RFK Jr. has his sights set on increasing advertising enforcement against pharmas, but may not come down as hard on the industry as previously thought.

    By Amy Baxter • Aug. 20, 2025
  • Boxes of the diabetes drug Ozempic rest on a pharmacy counter on April 17, 2023 in Los Angeles, California.
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    Mario Tama / Getty via Getty Images
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    Despite FDA ruling, compounded GLP-1s are still giving Novo and Lilly headaches on the market

    Copycat weight loss drugs were supposed to be pulled from the market, but pharmacies have found a loophole. 

    By Amy Baxter • Aug. 18, 2025
  • Vaccine
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    Alex Wong via Getty Images
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    With scrapped mRNA funding, a vaccine maker finds a silver lining

    While mRNA is suffering the brunt of the MAHA movement with $500 million in funding cuts, other vaccine makers could fill some of that void.

    By Aug. 14, 2025
  • President Donald Trump speaks to reporters at the the Lehigh Valley International Airport on Aug. 3, 2025, in Allentown, Pennsylvania.
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    Anna Moneymaker via Getty Images
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    With FDA PreCheck, drugmakers may get a manufacturing boost

    The newly announced program targeting domestic manufacturing is the latest Trump administration move to ramp up drugmaking in the U.S.

    By Amy Baxter • Aug. 13, 2025
  • Puerto Rico flag
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    Puerto Rico’s ongoing journey from manufacturing hub to innovation enterprise

    Biotechs are coming to the island as tariffs threaten overseas drug exports, and finding Puerto Rico is more than just a leading manufacturing hub.  

    By Aug. 12, 2025