Policy & Regulation


  • 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

    Drug price negotiations: 5 key dates to watch

    As the CMS readies its new program for lowering drug costs, these are the moments that will matter most to pharma companies.

    By Kelly Bilodeau • Jan. 23, 2023
  • The headquarters of the FDA, which has recently issued a recall for Teleflex air filters used in hospital respirators.
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    Sarah Silbiger/Getty Images via Getty Images

    FDA’s 2022 drug approvals fall short of recent norms

    The U.S. agency’s lower number of novel drug approvals followed several controversies surrounding a 2021 Alzheimer’s approval.

    By Alexandra Pecci • Jan. 19, 2023
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    Carsten Koall via Getty Images

    After ‘limping along,’ Novavax sees a path forward

    With a new CEO and a long-term booster strategy, the company believes there’s plenty of room to grow in the COVID-19 vaccine space.

    By Jan. 18, 2023
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    Cemile Bingol via Getty Images

    Lilly, Biogen, Eisai brace for Alzheimer’s boom or bust in 2023

    As controversies abound and new drugs rise on the regulatory horizon, this year will be big for Alzheimer’s.

    By Jan. 5, 2023
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    Stock via Getty Images
    Opinion

    The 2023 PharmaVoice Crystal Ball: Peering into the future of life sciences

    A preview of the top trends on the minds of industry and market leaders for the new year.

    By Jan. 3, 2023
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    Illustration: Alberto Miranda for Industry Dive

    Tracker

    The 2023 PharmaVoice Year in Preview

    Here’s a look at how industry leaders are navigating the key issues of 2023.

    Dec. 12, 2022
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    Courtesy of Sarepta
    Q&A

    For Duchenne-focused Sarepta, gene therapy is the natural next step

    The company with three marketed RNA drugs for Duchenne muscular dystrophy is taking the logical leap into gene therapies with a candidate under review at the FDA.

    By Dec. 8, 2022
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    Permission granted by CSL
    Q&A

    A historic approval could transform CSL from being ‘the biggest company no one has ever heard of’

    The company’s head of R&D on its profile-raising FDA approval of a gene therapy that’s now the world’s most expensive drug. 

    By Dec. 6, 2022
  • The front entrance of the Food And Drug Administration headquarters building.
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    Sarah Silbiger via Getty Images

    An FDA proposal could make OTC switches easier. Here’s what the industry has to say

    How the FDA’s proposal to create a new OTC approval pathway could impact the pharma industry.

    By Dec. 5, 2022
  • 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

    5 final FDA action dates to watch this year

    A potential flurry of regulatory activity could be on the horizon yet this year — and several key drug approvals are at stake.

    By Dec. 1, 2022
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    Stock via Getty Images

    10 of our most popular articles in 2022

    Methadone, rock ‘n’ roll, clinical trial overhauls — here’s a look at our most-read stories of the year.

    By Nov. 30, 2022
  • A view of a sign that reads, "Kendall square: central square, Harvard square, cinema" is framed by a pill outline.
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    Photo illustration: Shaun Lucas and Karissa Waddick/Industry Dive; Getty Images 

    The next era of Greater Boston’s biotech boom

    How Boston became the biotech capital of the U.S., and is now preparing for the next era of life sciences growth.  

    By , , Nov. 22, 2022
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    TierneyMJ/Shutterstock.com

    Sponsored by ClinicalMind

    Can a formal needs assessment simplify Speaker Bureau compliance?

    In the biopharmaceutical industry, phases of innovation and change are often driven by regulatory action.

    Nov. 21, 2022
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    iStock via Getty Images
    Opinion

    Why the IRA will drive up the country’s drug bill — not lower it

    On the surface, the Inflation Reduction Act is designed to lower drug prices, but its impact on innovation incentives could produce a landscape of new medicines that are costlier for patients.

    By John LaMattina • Nov. 14, 2022
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    Baris-Ozer via Getty Images

    3 ways pharma can weather a recession

    If “winter is coming” in the form of a recession, pharmas can take advantage of an inherent resiliency by crushing these three fundamentals.

    By Nov. 10, 2022
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    adamkaz / iStock / Getty Images Plus via Getty Images

    What pharma could gain — or lose — from the midterms

    With control of the House and Senate both up for grabs, and potentially leaning Republican, here’s what the midterm elections mean for pharma. 

    By Nov. 7, 2022
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    Stock via Getty Images

    Acumen cruises into the fast lane with novel Alzheimer’s treatment

    The company’s distinct amyloid-beta target, which just won a fast track designation, could give it an edge over the competition.

    By Nov. 3, 2022
  • In the distance, exhaust plumes billow over seven power plants. The reflection of the power plants can be seen in a lake.
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    Sean Gallup / Staff via Getty Images

    How Europe’s energy crisis is impacting pharma

    Inflationary pressures and rising energy costs could further expedite the movement of generics manufacturing from Europe to Asia if governments don’t step in.

    By Nov. 2, 2022
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    Permission granted by Biogen

    Riches, rags, riches: Is Biogen the Cinderella of biotechs?

    Biogen and Eisai's new Alzheimer's drug is wowing investigators, and it might help the companies get past previous failures.

    By Oct. 27, 2022
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    Diego Camargo/PharmaVoice
    Podcast

    Woman of the Week: Ironwood Pharmaceuticals’ Diane Stroehmann

    The VP of regulatory affairs and global patient safety explains why her line of work lets her do “a little of everything,” and the company’s plans to score a new approval for its blockbuster drug.

    By Oct. 26, 2022
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    Jackfoto via Getty Images

    Biosimilars will gain ground in 2023 with Humira launches — and that’s just the beginning

    In Amgen's 2022 Biosimilars Trend Report, the company tracks the progress and potential of the copycat drugs as they reach a pivotal moment.

    By Oct. 24, 2022
  • A picture of Xavier Becerra giving a speech at a podium
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    Alex Wong via Getty Images

    Think your company could be on HHS’ drug price negotiation list? Here’s how to navigate next steps

    Know what to expect from the CMS over the next few months as it implements the drug reforms laid out in the Inflation Reduction Act.

    By Oct. 18, 2022
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    iStock via Getty Images
    Making Moves

    BIO’s interim CEO and Alvotech’s new chief quality officer could spell big changes for biotech

    What these life science organizations’ latest executive-level appointments mean for the industry.

    By Oct. 14, 2022
  • Dr. Preeti Parikh, executive medical director at GoodRx
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    Sponsored by GoodRx

    Beyond buzzwords: Making a practice of diversity, equity and inclusion

    Watch Dr. Preeti Parikh, executive medical director at GoodRx, explain how she sees parallels between her mother’s challenges to promote health equity as a physician, and current diversity, equity, and inclusion (DE&I) challenges in the workplace.

    Oct. 10, 2022
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    Permission granted by Asia Kepka

    Q&A

    Her antibiotic company failed. Now she’s helping others avoid the same fate.

    The chief of R&D at CARB-X explains why she believes small antibiotics companies can succeed despite market turmoil.

    By Oct. 6, 2022