Policy & Regulation: Page 3


  • FluMist
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    Mario Tama / Getty via Getty Images
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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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    Permission granted by NYU
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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
  • digital pill Explore the Trendline
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    Stock via Getty Images
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    Trendline

    Artificial intelligence & machine learning

    After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.

    By PharmaVoice staff
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    Stock via Getty Images
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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
  • Phenylephrine
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    Joe Raedle / Getty Images via Getty Images
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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
  • A close up a cell with a large screen in the background displaying a injection needle.
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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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    Permission granted by Alnylam/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
  • Judge gavel and pills against blue backdrop
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    Stock via Getty Images
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    Drugmakers face uphill battle in Medicare negotiation suits

    Judges have found fault with drug manufacturers’ First and Fifth Amendment arguments against the IRA’s drug pricing measures.

    By Karissa Waddick • Oct. 4, 2023
  • A photograph of the exterior of the Food and Drug Administration headquarters in Maryland.
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    Sarah Silbiger via Getty Images
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    5 FDA decisions to watch in the fourth quarter

    The regulator is considering approval of what would be the first CRISPR medicine, as well as important clearances for Alnylam, Bristol Myers, Amgen and Pfizer.

    By Ned Pagliarulo , Jonathan Gardner • Oct. 2, 2023
  • spilling cough syrup
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    Stock via Getty Images
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    3 recent FDA adcomm rejections — and why they matter

    Decisions that could spell doom for drugs in development and already on the shelves.

    By Sept. 29, 2023
  • Business people leaning over a table together analyzing charts and graphs.
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    Tinnakorn Jorruang via Getty Images
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    How pharma marketers can reclaim the drug pricing narrative

    As Medicare negotiations heat up, it’s more important than ever for pharma companies to communicate their value. Here’s how.

    By Karissa Waddick • Sept. 28, 2023
  • Opioids, pills, syringe
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    iStock via Getty Images
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    Q&A

    As the opioid crisis seethes, a long-lasting treatment could offer new ammunition

    Launched this month, Brixadi from Braeburn gives patients a new tool to overcome addiction.

    By Sept. 21, 2023
  • Congressman Garcia gestures to a cardboard meme of two identical Spiderman characters pointing at one another.
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    Rebecca Pifer/PharmaVoice
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    PBMs, PhRMA trade blame over drug costs in House hearing

    Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second PBM hearing on Tuesday.

    By Rebecca Pifer • Sept. 19, 2023
  • GCAppclemex side view with person
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    Permission granted by West Pharmaceutical Services
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    Sponsored by West Pharmaceutical Services

    De-risking visible particles through component selection

    The visual inspection of injectable drug product has been a regulatory requirement since 1936, however, successful implementation of the standard has been challenging for many organizations.

    By John Rech • Sept. 18, 2023
  • Close up of a machine with several tubes, some of which are red.
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    saengsuriya13 via Getty Images
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    Q&A

    In the renal space, innovation could tackle health disparities. But the system doesn’t reward it.

    Reimbursement challenges have created barriers for new dialysis products, according to the chief commercial officer of CorMedix.

    By Sept. 14, 2023
  • pharmacist scanning prescription
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    Stock via Getty Images
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    A healthcare paradox: Drugs are too expensive but ‘easy’ to afford, Americans say

    A new poll shows that Americans generally support several key IRA provisions, including Medicare price negotiations.

    By Alexandra Pecci • Sept. 12, 2023
  • Close up of conference room with glasses of water on the table with papers, armchairs and a large window.
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    Igor Kutyaev via Getty Images
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    Ex-Sanofi executive Sibold joins Madrigal as new CEO

    Bill Sibold has led Sanofi's specialty care business unit for the past six years. He replaces Paul Friedman as head of the NASH drug developer.

    By Ned Pagliarulo • Sept. 11, 2023
  • A prescription bottle with white pills and a wooden gavel sit atop a $100 bill showing Benjamin Franklin's face.
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    Bill Oxford via Getty Images
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    Lawmakers are already gunning for more dramatic drug pricing reforms

    Medicare just announced its first-ever drug price negotiations and legislators are quickly pushing to broaden the program.

    By Karissa Waddick • Aug. 31, 2023
  • CSL Seqirus influenza vaccine being prepared in the lab.
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    Permission granted by CSL Seqirus
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    Finding the right flu vaccine is hard. Getting people to take it is harder.

    Experts have determined the strains of this year’s flu season — now the question is whether people are too fatigued by the pandemic to be immunized.

    By Aug. 30, 2023
  • Joe Biden stands at a podium flanked on either sides by screens that read: "lowering costs for American families."
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    Win McNamee / Staff via Getty Images
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    Medicare named the first 10 drugs up for negotiation. Now what?

    The list of blockbuster cardiovascular, diabetes and cancer drugs gives the industry a window into how regulators are approaching price negotiations.

    By Karissa Waddick • Aug. 30, 2023
  • Pills of varying colors lay against a blue background
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    Stock via Getty Images
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    Drug shortages: The ‘fundamental problem’ that has pharma’s top regulator ‘fired up’

    FDA Commissioner Robert Califf suggested larger reforms are needed to bolster the generic drug industry and prevent future medication shortages. 

    By Karissa Waddick • Aug. 25, 2023
  • COVID shot
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    Joe Raedle / Staff via Getty Images
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    ‘Eris’ and other new COVID strains accelerate vaccine push from Pfizer, Moderna, Novavax

    New variants drive a need for another round of shots, and biopharma companies are stepping up to the plate.

    By Aug. 24, 2023
  • Dr. Vivian Cheung, head of Vivian Cheung Lab at University of Michigan
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    Permission granted by Vivian Cheung Lab
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    Profile

    A rare disease researcher aims to tackle disability discrimination in new lawsuit

    How a pediatric neurologist is advocating for herself and the disabled community in a legal battle with the Howard Hughes Medical Institute.

    By Alexandra Pecci • Aug. 22, 2023