Policy & Regulation: Page 3


  • 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
  • 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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    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
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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
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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
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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
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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
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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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    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
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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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    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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    Carsten Koall/Getty Images via Getty Images
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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
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    Express Scripts Holding Co.
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    Express Scripts sued by independent pharmacies over alleged price fixing

    The Cigna-owned pharmacy benefit manager colluded with rival Prime Therapeutics to overcharge pharmacies, according to a lawsuit filed last week.

    By Rebecca Pifer • Oct. 25, 2023
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    The FDA might yank cold medicines from shelves — and that could be just the beginning

    Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.

    By Alexandra Pecci • Oct. 17, 2023
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    Gregor Fischer/DPA/Newscom

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    Deep Dive

    A decade later, biotech’s CRISPR revolution is still going strong

    Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.

    By Gwendolyn Wu , , Oct. 12, 2023
  • Alnylam Pharmaceuticals CEO Yvonne Greenstreet
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    Alnylam CEO, ‘disappointed’ with FDA’s Onpattro rejection, pivots to the future

    Yvonne Greenstreet, CEO of RNAi specialist Alnylam, addressed the surprise move by regulators and the company’s new future plans.

    By Oct. 12, 2023
  • Emil Kakkis
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    Permission granted by Dr. Emil Kakkis.

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    FDA’s ‘ivory tower thinking’ ignores promising biomarkers, says a rare disease CEO

    The FDA wouldn’t review a drug that was 90% effective. In rare diseases, this is too common, said Ultragenyx CEO Dr. Emil Kakkis and a leading rare disease researcher.

    By Oct. 5, 2023