Policy & Regulation


  • A photograph of a Sarepta building in Boston, MA
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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
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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
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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
  • Colonies of bacteria in MacConkey agar
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    Md Saiful Islam Khan via Getty Images

    Feds could soon bring COVID-style fight to superbug threat

    COVID-19 has inspired renewed urgency in the need for weapons to combat antimicrobial resistant infections and new hope of government funding to meet the challenge.

    By Sept. 13, 2022
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    Iryna Imago via Getty Images

    Drug recalls are ticking upwards — here’s how to avoid costly pitfalls

    Supply chain challenges, labor shortages and increased FDA inspections are boosting recall risks — but careful planning can keep companies in the clear.

    By Kelly Bilodeau • Sept. 8, 2022
  • Glass vials of Moderna COVID-19 vaccine.
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    Gabriel Kuchta via Getty Images

    Moderna’s lawsuit against Pfizer and BioNTech explained in 10 quotes

    The biotech says that its competitors’ COVID-19 vaccine copied proprietary mRNA technology. Here’s a breakdown of the case.

    By Aug. 31, 2022
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    Permission granted by Alvotech. 

    Hurdles remain in biosims market — but Alvotech is undeterred

    The biosimilar developer is advancing a pipeline with high growth potential, including a copycat of Humira.

    By Kelly Bilodeau • Aug. 29, 2022
  • President Biden signs the Inflation Reduction Act surrounded by members of congress and backed by American flags in the White House.
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    Drew Angerer via Getty Images

    3 ways pharma can prep for Biden’s sweeping drug pricing policies

    Now that Medicare will be able to negotiate drug prices under the Inflation Reduction Act, the industry can expect to see some changes. Here are some tips on how to navigate the changing tide.

    By Aug. 18, 2022
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    Sarah Silbiger via Getty Images

    The FDA is mulling an OTC approval for a birth control. Will politics factor in?

    Analysts are watching how cultural and political debates around reproductive rights may impact HRA Pharma's OTC birth control application.

    By Aug. 15, 2022