Policy & Regulation: Page 4


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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
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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
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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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    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
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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
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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
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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
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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
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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
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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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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