Policy & Regulation: Page 3


  • 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
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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
  • 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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    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
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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
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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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    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
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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
  • Quita Highsmith header
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    Q&A

    The many ‘myths’ of clinical trial diversity, and Genentech’s fight to disrupt them

    Genentech’s chief diversity officer Quita Highsmith is on a crusade to prove that much of what the industry believes about clinical trial diversity is wrong.

    By Dec. 14, 2023
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    What’s being done to prepare for the next pandemic?

    Will the world be ready when a new outbreak hits? Here’s a look at the efforts to combat emerging viral threats.

    By Kelly Bilodeau • Dec. 13, 2023
  • Dr. Julie Gerberding headshot
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    Q&A

    A former CDC head on key R&D areas, public trust and if we learned anything from COVID-19

    Dr. Julie Gerberding, now president and CEO of the Foundation for the National Institutes of Health, shares lessons learned from a long career in academic, public health and industry.

    By Dec. 13, 2023
  • Shankar Narayanan, CEO, Real Chemistry
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    Real Chemistry’s CEO on biopharma’s outlook in 2024

    Shankar Narayanan, CEO of marketing consulting firm Real Chemistry, weighs in on where the industry is headed in the New Year.

    By Dec. 7, 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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    4 historic FDA approvals from 2023

    This year’s many firsts included a vaccine for RSV and a drug that slows Alzheimer’s disease.

    By Alexandra Pecci • Dec. 6, 2023
  • A CRISPR Therapeutics sign is seen above a door to an office building
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    CRISPR eyes autoimmune disease in revamp of cell therapy plans

    The gene editing biotech is shelving two of its most advanced cancer drugs, and joining a growing group of companies exploring cell-based medicines for inflammatory diseases like lupus.

    By Ben Fidler • Dec. 6, 2023
  • Closeup shot of an unrecognizable doctor using a digital tablet.
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    The digital therapeutics revolution is here. Will payers play ball?

    Apps, VR and more could play an increasingly vital role in the wider goals of creating value-based treatments — if the industry can get payers to sign on.

    By Kelly Bilodeau • Dec. 5, 2023
  • A printed copy of the 2017 Tax Cut and Jobs Act is seen lying on a desk with other papers.
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    Chip Somodevilla via Getty Images
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    Deep Dive

    Pharma benefited from basing business overseas. An international tax effort could spur a rethink.

    U.S. tax law changes six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.

    By Jonathan Gardner • Nov. 29, 2023
  • Janet Woodcock in senate
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    Top FDA official Woodcock to retire early next year

    The 37-year veteran helmed the agency’s pandemic response, and was a key decision-maker in controversial calls on opioids, an Alzheimer's therapy and muscular dystrophy drugs.

    By Jonathan Gardner • Nov. 16, 2023
  • A photograph of a Sarepta building in Boston, MA
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    Courtesy of Sarepta
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    Can Sarepta’s Duchenne gene therapy still deliver on its promise?

    For Sarepta — and DMD patients — there’s a lot riding on the treatment’s next steps.

    By Kelly Bilodeau • Nov. 14, 2023
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    zennie via Getty Images
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    How pharma leaders talk about ethics in a highly criticized industry

    The maze of ethical issues in biopharma can confound even the wiliest executive. How do some leaders get by?

    By Nov. 9, 2023
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    An at-home flu vaccine? If approved, it could open the door to more DIY options

    A new way to administer vaccines at home could help AstraZeneca reach a wider market for FluMist, the nasal influenza vaccine.

    By Kelly Bilodeau • Nov. 8, 2023
  • Arthur Caplan, professor of bioethics and founding head of the Division of Medical Ethics, NYU’s Grossman School of Medicine
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    Opinion

    The thorniest questions facing pharma, according to a leading bioethicist

    Bioethics guru Arthur Caplan of NYU gives his outspoken and frank opinion on the industry’s minefield of ethical challenges.

    By Nov. 6, 2023
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    In a record year for biotech bankruptcy, here are 3 companies that went under

    A challenging funding environment and lack of partnering deals have contributed to the market's ongoing troubles.

    By Alexandra Pecci • Nov. 2, 2023
  • Ampoules of Novavax's COVID-19 vaccine prepared in Berlin, Germany.
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    What’s next for COVID dark horse Novavax?

    Novavax scored a new COVID vaccine go-ahead for the 2023-24 season, but is it the boost the company needs?

    By Kelly Bilodeau • Oct. 30, 2023