Policy & Regulation: Page 4


  • pharmacist scanning prescription
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Igor Kutyaev via Getty Images
    Image attribution tooltip

    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
  • biotech market Explore the Trendline
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip
    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
  • A prescription bottle with white pills and a wooden gavel sit atop a $100 bill showing Benjamin Franklin's face.
    Image attribution tooltip
    Bill Oxford via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Permission granted by CSL Seqirus
    Image attribution tooltip

    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."
    Image attribution tooltip
    Win McNamee / Staff via Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Joe Raedle / Staff via Getty Images
    Image attribution tooltip

    ‘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
    Image attribution tooltip
    Permission granted by Vivian Cheung Lab
    Image attribution tooltip
    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
  • Rep. Adam Smith sits at a podium with blue curtain behind.
    Image attribution tooltip
    Chip Somodevilla / Staff via Getty Images
    Image attribution tooltip
    Q&A

    A leading Democrat reveals how his mental health struggles shape his policy approach

    Seattle Congressman Adam Smith's journey with anxiety and chronic health has influenced his perspective on healthcare and pharmaceutical policy.

    By Karissa Waddick • Aug. 17, 2023
  • vaccine vial
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    Pharma’s rare disease rush

    Biogen’s acquisition of Reata Pharmaceuticals is the latest in a string of high-dollar rare disease deals over the last few months. What does it mean for industry?

    By , Karissa Waddick • Aug. 14, 2023
  • drug pricing protest
    Image attribution tooltip
    Anna Moneymaker via Getty Images
    Image attribution tooltip

    PBMs could soon feel the regulatory sting

    From Congress to the FTC to state legislatures, regulators are cracking the whip against PBMs.

    By Karissa Waddick • Aug. 4, 2023
  • J&J CEO Joaquin Duato
    Image attribution tooltip
    Mike Coppola via Getty Images
    Image attribution tooltip

    Big Pharma CEOs get candid about pricing and M&A

    Head honchos at the biggest pharma companies reporting second-quarter earnings dig into the topics du jour.

    By July 28, 2023
  • An AbbVie sign is seen on a building at the pharmaceutical company's U.S. headquarters.
    Image attribution tooltip
    Courtesy of AbbVie
    Image attribution tooltip

    Biosimilar makers split strategies in bid to take on top-selling Humira

    In challenging AbbVie for share of a $19 billion drug market, competitors are testing whether high upfront discounts or behind-the-scenes rebates can win them an advantage.

    By Jonathan Gardner • July 26, 2023
  • Oral contraceptive pill on pharmacy counter with colorful pills strips background.
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip
    Q&A

    With OTC birth control approved, access battles have just begun

    Perrigo received the first FDA approval for an OTC birth control pill. Now, its global VP of women’s health says the company is working on the next challenge — affordability.  

    By Karissa Waddick • July 26, 2023
  • Pregnancy
    Image attribution tooltip
    FG Trade via Getty Images
    Image attribution tooltip

    For Merck, understanding maternal mortality is the first step toward equity

    Merck has invested for more than a decade in reducing maternal death rates in the U.S. and globally. Now for the next chapter.

    By July 25, 2023
  • The U.S. Capitol building photographed at dusk from the front left.
    Image attribution tooltip
    Marc Dufresne via Getty Images
    Image attribution tooltip

    4 controversial measures in Congress’ pandemic preparedness bill

    Efforts to tackle drug pricing, shortages, the speed of FDA approvals and more have been mixed into Congress’ efforts to reauthorize the Pandemic and All Hazards Preparedness Act.

    By Karissa Waddick • July 20, 2023
  • Smart watch cardiac monitor
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    DCTs create fresh privacy challenges for review boards. Now there are guidelines.

    A new toolkit developed by industry stakeholders paves the way for faster reviews.

    By Kelly Bilodeau • July 17, 2023
  • fractural colors with white outline of mind
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    FDA’s upcoming psychedelic review looms large for a budding industry

    A new psychedelic guidance from the agency gives a clue into how it could analyze drugs in the space, but industry leaders are eager for more.

    By Karissa Waddick • July 12, 2023
  • A vial of Eisai and Biogen's Alzheimer's disease drug Leqembi
    Image attribution tooltip
    Courtesy of Eisai
    Image attribution tooltip

    Following FDA’s full approval of Leqembi, here’s what else is in the Alzheimer’s pipeline

    Leqembi’s U.S. approval is a milestone in Alzheimer’s research and medicine — and there are a few other late-stage biologic drugs that could follow.

    By July 7, 2023
  • Legal finance
    Image attribution tooltip
    matt_benoit via Getty Images
    Image attribution tooltip

    Pharma’s strike-from-all-sides attack on the IRA could be decided by the Supreme Court

    New lawsuits challenging the Inflation Reduction Act’s price negotiation program hit the government with multiple Constitution-based challenges.

    By Alexandra Pecci • July 6, 2023
  • Stethoscope , passport document, airplane and globe on a table.
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip
    Q&A // First 90 Days

    A BMS exec’s journey around the world in 90 days

    As BMS grapples with upcoming patent cliffs, Emma Charles, the new SVP of intercontinental markets, is focused on expanding its footprint.

    By Karissa Waddick • July 5, 2023
  • Colorful drug capsules against a yellow background
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    The stories you’ve read the most in 2023 (so far)

    From staff shortages to presidential candidates and the M&A outlook, here are our most-read stories from the first half of the year.

    By PharmaVoice Staff • July 3, 2023
  • Liver
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip

    Intercept’s NASH retreat is the latest setback for a challenging liver disease

    Intercept Pharmaceuticals has stepped out of the race to the first U.S. approved treatment for the complicated liver disease NASH, leaving room for other pharmas to get their foot in the door.

    By June 27, 2023
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    The spotlight is on accelerated approvals — now FDA could run a tighter ship

    As the fallout of the Aduhelm approval continues, scrutiny of the speedier pathway has increased and the pressure is on to close a key gap in the regulation.

    By Kelly Bilodeau • June 20, 2023
  • Pieces of paper cut out in the shape of human heads with question marks written on top lie on a blue background.
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    How pharma execs are approaching drug pricing and other quandaries

    From implementation of the Inflation Reduction Act, to the looming patent cliff and more, pharma leaders have a lot on their plates.

    By Karissa Waddick • June 16, 2023