Policy & Regulation: Page 10


  • Pharma reputation broken pill
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip

    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
  • Exterior of FDA headquarters
    Image attribution tooltip
    Courtesy of U.S. Food and Drug Administration
    Image attribution tooltip

    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
  • rare disease ribbon Explore the Trendline
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip
    Trendline

    Rare diseases

    As drug developers find promise in the rare diseases, deals and treatments are on the rise

    By PharmaVoice staff
  • pills rising
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip
    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.
    Image attribution tooltip
    drnadig via Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Anna Moneymaker/Staff via Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
    Image attribution tooltip

    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
    Image attribution tooltip
    (2021). Retrieved from NCI.
    Image attribution tooltip
    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.
    Image attribution tooltip
    artJazz via Getty Images
    Image attribution tooltip

    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
  • long covid concept
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Permission granted by Christopher Boone AbbVie
    Image attribution tooltip
    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
  • fda
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    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
  • A person holds an insulin pen
    Image attribution tooltip
    agrobacter via Getty Images
    Image attribution tooltip

    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
  • Neena Patil Jazz Pharmaceuticals
    Image attribution tooltip
    Permission granted by Neena Patil
    Image attribution tooltip
    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.
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Permission granted by GoodRx
    Image attribution tooltip
    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
  • COVID vaccine development
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip

    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
  • Young people sitting on the stairs and using smartphones.
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    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
  • Vaccine
    Image attribution tooltip
    David Greedy/Getty Images via Getty Images
    Image attribution tooltip

    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
  • Image attribution tooltip
    Spencer Platt via Getty Images
    Image attribution tooltip

    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
  • magic wand
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip
    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
  • pill explosion
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    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
  • U.S. Supreme Court building
    Image attribution tooltip
    Al Drago/Getty Images via Getty Images
    Image attribution tooltip

    SCOTUS to decide ‘fundamental change’ in biologics patents with fate of Amgen v. Sanofi

    The Supreme Court will now decide whether Amgen can protect Repatha as a whole class of drugs or whether Sanofi’s rival product Praluent can retain a place in the market.

    By March 28, 2023
  • A person stands outside of a building that says 'Silicon Valley Bank' with their hand on their chin.
    Image attribution tooltip
    Justin Sullivan via Getty Images
    Image attribution tooltip

    SVB’s collapse had limited impact on biopharmas — but a broader financial crisis could change the landscape

    Although many pharma and biotech companies had deposits at the failed bank, most have reported little to no exposure.

    By March 21, 2023
  • A glass building with a sign that reads,  "Biogen."
    Image attribution tooltip

    Paul Marotta/Sipa USA/Newscom

    Image attribution tooltip
    Making Moves

    In the fallout from Aduhelm, Biogen’s leadership shakeup continues

    The recent departure of neurodegenerative development head Samantha Budd Haeberlein is just the latest sign of a changing tide among Biogen’s post-Aduhelm leadership.

    By Karissa Waddick • March 16, 2023
  • U.S. President Joe Biden speaking in Philadelphia.
    Image attribution tooltip
    Chip Somodevilla/Staff/Getty Images News via Getty Images
    Image attribution tooltip

    Biden doubles down on drug pricing in 2024 budget — but boosts R&D

    The president’s 2024 budget proposal expands on last year’s drug pricing reforms, but also dramatically increases innovation investments.

    By Karissa Waddick • March 13, 2023