Policy & Regulation: Page 2


  • House Energy And Commerce Committee Chair Cathy Rodgers stern look
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    After ‘tragic’ bacterial outbreak, lawmakers press FDA to step up foreign inspections

    Impatience to fix long-held challenges to overseas drug facility inspections is growing on Capitol Hill.

    By March 1, 2024
  • Thorny issues in pharma
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    How a 15-year-old Genzyme drug shortage became a legal smorgasbord of pharma’s thorniest issues

    Rare disease treatments, drug shortages, a market monopoly and march-in rights all play a role in the story of newly revived litigation against Sanofi’s Genzyme.

    By Alexandra Pecci • Feb. 26, 2024
  • 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
  • Iovance hallway
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    Permission granted by Iovance Biotherapeutics
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    Behind the breakthrough cancer therapy that just won a historic FDA nod

    The first-of-its-kind TIL therapy for solid tumors developed by Iovance Biotherapeutics won FDA approval last week.

    By Kelly Bilodeau • Feb. 21, 2024
  • Joe Biden, Donald Trump
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    Biden or Trump: How deeply will 2024’s election outcome impact pharma?

    The election is still months away, but campaign promises are solidifying, and signal the benefits and drawbacks of each candidate for pharma.

    By Feb. 20, 2024
  • Dr. Robert Califf, FDA commissioner, speaking at a podium with hands up
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    FDA inches closer to defining its regulatory role in AI

    Commissioner Dr. Robert Califf signals how the FDA will consider AI in drug development and how the agency may use the emerging technology in the future.

    By Feb. 12, 2024
  • Yoshi Shitaka
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    Astellas’ science chief on the leap into new technologies

    After a big 2023, Yoshi Shitaka said the company is banking on gene therapies, KRAS degraders and more to keep the momentum.

    By Feb. 9, 2024
  • Pill drug money balance
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    ‘Beginning of the end’ for small molecules? VCs brace for Medicare investment gap

    The "small molecule penalty" becomes even riskier for investors as the IRA negotiates prices, and VCs and lawmakers are looking to get a jump on those headwinds.

    By Feb. 6, 2024
  • Empty congressional chamber
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    Brendan Hoffman via Getty Images
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    Government hits patent thickets on multiple fronts

    Patent thickets are the latest target in lawmakers' bid to lower drug prices.

    By Alexandra Pecci • Feb. 5, 2024
  • Pfizer CEO Albert Bourla
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    Pfizer’s COVID vax and antiviral sales have crashed. Will the ‘big bet’ on Seagen even the keel?

    In the first earnings call since the $43 billion Seagen deal closed, CEO Albert Bourla stressed that Pfizer is all in on the promise of ADCs to make up for COVID losses.

    By Feb. 1, 2024
  • Exterior sign of Bristol-Myers Squibb
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    CAR-T developers respond to FDA black box warning

    Despite a recent safety warning from the FDA, companies such as BMS and J&J stress that the benefits of their cancer therapies still outweigh the risks.

    By Kelly Bilodeau • Jan. 30, 2024
  • A blood sample of HER2 for breast cancer diagnosis.
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    AstraZeneca, Daiichi aim for first pan-tumor ADC approval

    A “tumor agnostic” FDA approval for the companies’ Enhertu would break new ground for antibody-drug conjugates. 

    By Ben Fidler • Jan. 29, 2024
  • 2024 outlook
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    The biggest questions hanging over pharma in 2024

    Key trends on the horizon in the life sciences this year.

    By Jan. 25, 2024
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    Stock via Getty Images
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    Breast cancer tops list of most studied diseases

    The most studied diseases last year included three types of cancer as research into COVID-19 fell sharply in the post-pandemic era.

    By Kelly Bilodeau • Jan. 24, 2024
  • Close-up of a sign with office building and trees in background
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    FDA looks to execute ‘largest reorganization in history’ this year

    What started as an examination of the Human Foods Program has expanded into an agencywide overhaul.

    By Alexandra Pecci • Jan. 23, 2024
  • Pharma progress
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    How to make 2024 a banner year for biopharma, despite the headwinds

    Creative thinking is the name of the game as biopharmas seek to overcome a host of challenges — and investing with purpose, building trust and embracing tech could get them there.

    By Jan. 18, 2024
  • Covid doctor
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    An enduring COVID mystery: Why some do fine and others die

    The infectious disease market could be shifting toward a future not only focused on the microbe, but on the unique genetic attributes of the host.

    By Alexandra Pecci • Jan. 17, 2024
  • A man speaks in front of a microphone at a hearing.
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    Kevin Dietsch via Getty Images
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    FDA chief says agency can’t manage health tech alone

    FDA Commissioner Dr. Robert Califf recently spoke about the future of AI and machine learning and the need for constant vigilance to improve healthcare systems.

    By Alexandra Pecci • Jan. 16, 2024
  • Green light
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    4 big FDA approval dates to watch in 2024

    Following a year where the FDA approved 55 new drugs, the 2024 PDUFA calendar is set with a number of potentially buzzy approvals. 

    By Alexandra Pecci • Jan. 12, 2024
  • San Francisco
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    Opinion

    Pharma execs sound off on trends and policies they’re tracking in 2024

    From regulatory concerns to leadership skills, pharma leaders at JPM shared how they’re approaching the coming year.

    By Jan. 12, 2024
  • 2024 Crystal Ball Trials
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    Opinion // Year in Preview

    PharmaVoice’s Crystal Ball: What’s next in drug innovation and clinical trials

    As advanced therapies and patient perspectives strengthen their foothold in R&D, pharma is poised to deliver impactful treatments in record time.

    By Jan. 11, 2024
  • 2024 market
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    Opinion // Year in Preview

    PharmaVoice’s Crystal Ball: Perspectives on the financial future

    Industry leaders predict what it will take for pharma to defeat its financial foes in 2024.

    By Jan. 9, 2024
  • DNA vile
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    Regulatory twists and turns are coming for biopharma in 2024

    New FDA requirements and the IRA will create complexity in the coming year. Here’s how the industry can navigate the changes.

    By Kelly Bilodeau • Jan. 8, 2024
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    10 of our most read articles in 2023

    A presidential candidate, a changing biotech market and an enduring murder mystery — here are PharmaVoice’s most-read articles this year.

    By Dec. 22, 2023
  • ign on Doorway for the Federal Trade Commission in Washington D.C.
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    LD via Getty Images
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    Biopharma’s FTC headache deepens with guideline shifts years in the making

    Closer scrutiny of pharma deals has made the M&A landscape trickier as a new approach seeks to expand the competitive arena.

    By Dec. 21, 2023
  • drug prices
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    Study suggests PBMs are gaming pharmacy system to overcharge for drugs

    Markups for generics can be as high as 7,000%, the researchers said.

    By Alexandra Pecci • Dec. 15, 2023