Policy & Regulation: Page 5


  • 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
  • biotech market Explore the Trendline
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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
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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
  • Exterior of FDA headquarters
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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
  • Pharma reputation broken pill
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    iStock via Getty Images
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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
  • Storm clouds gather near the U.S. Capitol
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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
  • Federal Trade Commission
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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
  • Professional headshot of Monica Bertagnolli
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    (2021). Retrieved from NCI.
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    Making Moves

    Biden’s pick to lead the NIH faces an uphill battle

    Pending Senate confirmation, NCI head Monica Bertagnolli will take the helm of the collection of research organizations as it faces increasing bipartisan scrutiny. 

    By Karissa Waddick • May 18, 2023
  • The European Union flag.
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    artJazz via Getty Images
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    Major regulatory changes are coming to pharma in the EU — and industry’s weighing in

    The European Union published a long-awaited proposal that could bring sweeping changes to its pharma sector last month, but the legislative fight has only just begun.

    By Karissa Waddick • May 16, 2023
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    Years into the pandemic, only a handful of clinical trials are targeting long COVID — here’s one of them

    Scientists at Stanford are testing Pfizer’s Paxlovid on long COVID symptoms and their efforts could provide clues for other conditions.  

    By Kelly Bilodeau • May 15, 2023
  • Christopher Boone AbbVie
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    Permission granted by Christopher Boone AbbVie
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    Q&A

    AbbVie’s Christopher Boone on RWE’s potential — and its ‘profound ethical dilemmas’

    With decades of experience in public health, Boone is leveraging RWE to move the needle within clinical development.

    By May 10, 2023
  • A person holds an insulin pen
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    agrobacter via Getty Images
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    Insulin prices have dropped — will Civica still be a disrupter in the field?

    The nonprofit generics maker still sees a need for low-cost insulin despite recent moves by major drugmakers to slash the prices of their popular products. 

    By Karissa Waddick • May 8, 2023
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    3 key FDA approval trends this year

    Although approvals are off to a slow start in oncology, the agency has been living in the fast lane for neurological disorders and more.

    By Kelly Bilodeau • May 8, 2023
  • Neena Patil Jazz Pharmaceuticals
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    Permission granted by Neena Patil
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    Podcast

    Woman of the Week: Jazz Pharmaceuticals’ Neena Patil

    Patil’s dual interests in healthcare and law are at the intersection of her C-suite role.

    By May 3, 2023
  • An illustration of a globe with large multicolored pins pointing to countries.
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    Stock via Getty Images
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    Taking your biotech global? Here’s how you can navigate cultural norms

    What’s so different about doing pharma business in the U.K. versus Japan? One of Moderna’s top brass shares her tips for navigating choppy cultural waters.

    By Alexandra Pecci • May 2, 2023
  • Preeti Parikh, MD Executive Medical Director GoodRx
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    Sponsored by GoodRx

    A physician’s perspective on health equity, diversity and inclusion

    Dr. Preeti Parikh sees parallels between promoting health equity and current DE&I challenges in the workplace.

    By Preeti Parikh, MD, Executive Medical Director, GoodRx • April 24, 2023
  • Young people sitting on the stairs and using smartphones.
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    Stock via Getty Images
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    Patient influencers are here to stay — where are the regulations?

    As social media health influencers enter the world of pharma advertising, experts warn that more guardrails are needed to protect the industry and patients.

    By Karissa Waddick • April 17, 2023
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    iStock via Getty Images
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    A new era of COVID innovation is here

    With a $5 billion dollar infusion, a new White House program is helping catalyze development of next-gen treatments, from pan-coronavirus vaccines to enhanced antivirals. 

    By Kelly Bilodeau • April 17, 2023
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    David Greedy/Getty Images via Getty Images
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    Fighting vaccine hesitancy may require a new approach from pharma

    The COVID-19 pandemic highlighted an ongoing problem of vaccine hesitancy undermining public health efforts. One way pharmas can help is to change the narrative.

    By April 13, 2023
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    After working at Merck during the Vioxx scandal, this former sales rep is on a mission to fix the system

    The founder and CEO for the Accreditation Council for Medical Affairs is increasing accountability in pharma by emphasizing training, standards and ethics in medical affairs.

    By Alexandra Pecci • April 11, 2023
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    Opinion

    Leaders wave a magic wand at pharma’s thorniest issues

    The major challenges pharma leaders would solve with a quick flick of an imaginary wand.

    By PharmaVoice staff • March 31, 2023
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    Seamless clinical trials were created to make studies easier — instead, they’ve become more complex

    Experts weigh in on how companies can design better trials that merge two phases into one.

    By March 29, 2023