Policy & Regulation: Page 4


  • Rep. Adam Smith sits at a podium with blue curtain behind.
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    Chip Somodevilla / Staff via Getty Images
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    Q&A

    A leading Democrat reveals how his mental health struggles shape his policy approach

    Seattle Congressman Adam Smith's journey with anxiety and chronic health has influenced his perspective on healthcare and pharmaceutical policy.

    By Karissa Waddick • Aug. 17, 2023
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    Pharma’s rare disease rush

    Biogen’s acquisition of Reata Pharmaceuticals is the latest in a string of high-dollar rare disease deals over the last few months. What does it mean for industry?

    By , Karissa Waddick • Aug. 14, 2023
  • digital pill Explore the Trendline
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    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
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    Anna Moneymaker via Getty Images
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    PBMs could soon feel the regulatory sting

    From Congress to the FTC to state legislatures, regulators are cracking the whip against PBMs.

    By Karissa Waddick • Aug. 4, 2023
  • J&J CEO Joaquin Duato
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    Mike Coppola via Getty Images
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    Big Pharma CEOs get candid about pricing and M&A

    Head honchos at the biggest pharma companies reporting second-quarter earnings dig into the topics du jour.

    By July 28, 2023
  • An AbbVie sign is seen on a building at the pharmaceutical company's U.S. headquarters.
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    Courtesy of AbbVie
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    Biosimilar makers split strategies in bid to take on top-selling Humira

    In challenging AbbVie for share of a $19 billion drug market, competitors are testing whether high upfront discounts or behind-the-scenes rebates can win them an advantage.

    By Jonathan Gardner • July 26, 2023
  • Oral contraceptive pill on pharmacy counter with colorful pills strips background.
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    iStock via Getty Images
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    Q&A

    With OTC birth control approved, access battles have just begun

    Perrigo received the first FDA approval for an OTC birth control pill. Now, its global VP of women’s health says the company is working on the next challenge — affordability.  

    By Karissa Waddick • July 26, 2023
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    FG Trade via Getty Images
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    For Merck, understanding maternal mortality is the first step toward equity

    Merck has invested for more than a decade in reducing maternal death rates in the U.S. and globally. Now for the next chapter.

    By July 25, 2023
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    Marc Dufresne via Getty Images
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    4 controversial measures in Congress’ pandemic preparedness bill

    Efforts to tackle drug pricing, shortages, the speed of FDA approvals and more have been mixed into Congress’ efforts to reauthorize the Pandemic and All Hazards Preparedness Act.

    By Karissa Waddick • July 20, 2023
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    Stock via Getty Images
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    DCTs create fresh privacy challenges for review boards. Now there are guidelines.

    A new toolkit developed by industry stakeholders paves the way for faster reviews.

    By Kelly Bilodeau • July 17, 2023
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    FDA’s upcoming psychedelic review looms large for a budding industry

    A new psychedelic guidance from the agency gives a clue into how it could analyze drugs in the space, but industry leaders are eager for more.

    By Karissa Waddick • July 12, 2023
  • A vial of Eisai and Biogen's Alzheimer's disease drug Leqembi
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    Courtesy of Eisai
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    Following FDA’s full approval of Leqembi, here’s what else is in the Alzheimer’s pipeline

    Leqembi’s U.S. approval is a milestone in Alzheimer’s research and medicine — and there are a few other late-stage biologic drugs that could follow.

    By July 7, 2023
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    Pharma’s strike-from-all-sides attack on the IRA could be decided by the Supreme Court

    New lawsuits challenging the Inflation Reduction Act’s price negotiation program hit the government with multiple Constitution-based challenges.

    By Alexandra Pecci • July 6, 2023
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    Stock via Getty Images
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    Q&A // First 90 Days

    A BMS exec’s journey around the world in 90 days

    As BMS grapples with upcoming patent cliffs, Emma Charles, the new SVP of intercontinental markets, is focused on expanding its footprint.

    By Karissa Waddick • July 5, 2023
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    Stock via Getty Images
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    The stories you’ve read the most in 2023 (so far)

    From staff shortages to presidential candidates and the M&A outlook, here are our most-read stories from the first half of the year.

    By PharmaVoice Staff • July 3, 2023
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    Intercept’s NASH retreat is the latest setback for a challenging liver disease

    Intercept Pharmaceuticals has stepped out of the race to the first U.S. approved treatment for the complicated liver disease NASH, leaving room for other pharmas to get their foot in the door.

    By June 27, 2023
  • 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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    The spotlight is on accelerated approvals — now FDA could run a tighter ship

    As the fallout of the Aduhelm approval continues, scrutiny of the speedier pathway has increased and the pressure is on to close a key gap in the regulation.

    By Kelly Bilodeau • June 20, 2023
  • Pieces of paper cut out in the shape of human heads with question marks written on top lie on a blue background.
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    Stock via Getty Images
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    How pharma execs are approaching drug pricing and other quandaries

    From implementation of the Inflation Reduction Act, to the looming patent cliff and more, pharma leaders have a lot on their plates.

    By Karissa Waddick • June 16, 2023
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    Opinion

    Shaking up pharma: Change that leaders would like to see

    Industry execs give voice to the “game changers” they believe would have the greatest impact on the healthcare ecosystem for all.

    By June 16, 2023
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    Why cancer could be the ideal realm for psychedelic treatments

    The CEO of Sunstone Therapies said the results of a recent trial testing psilocybin in cancer patients with depression were “remarkable.”

    By June 9, 2023
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    Courtesy of U.S. Food and Drug Administration
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    FDA’s decentralized trials guidance leaves slate of fresh questions for industry

    Recent FDA guidance aims to bolster DCT adoption but provides little clarity on the patchwork of telemedicine laws that pose an obstacle to the approach.

    By Karissa Waddick • June 8, 2023
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    Yes, biopharma still has a reputation problem. These leaders are looking for solutions.

    Negative news is breaking down the public’s perception of the biopharma industry — but leaders around the industry have some ideas to fix it.

    By June 8, 2023
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    Opinion

    A key to ‘winning’ in today’s market — and other trends pharma leaders are tracking

    Healthcare pros share the market drivers they believe are having the biggest impact on the industry.

    By June 2, 2023
  • Detail view of the US Capitol east facade in the early morning sun.
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    drnadig via Getty Images
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    Lawmakers look to crack down on Big Pharma tax breaks

    As lawmakers shine a light on Big Pharma tax cuts, the industry’s business moves are coming under attack from multiple angles. 

    By Alexandra Pecci • May 31, 2023
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    Anna Moneymaker/Staff via Getty Images
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    3 FDA decisions that could be delayed if the U.S. defaults on its debt

    If federal lawmakers don’t vote to raise the debt limit by early June, these FDA actions could be impacted.

    By Karissa Waddick • May 30, 2023
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    Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
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    From FTC to SCOTUS, Amgen’s woes are potential ‘game changers’ for the industry

    The two institutional battles offer a glimpse into the tension between pharma innovation and regulation that could reverberate across the industry.

    By May 25, 2023