Policy & Regulation: Page 12

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    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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    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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    Trendline

    Rare diseases

    As drug developers find promise in the rare diseases, deals and treatments are on the rise

    By PharmaVoice staff
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    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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    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 Karissa Waddick • Nov. 7, 2022
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    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
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    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 Karissa Waddick • Nov. 2, 2022
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    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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    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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    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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    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 Karissa Waddick • Oct. 18, 2022
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    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 Karissa Waddick • Oct. 14, 2022
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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

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    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 Karissa Waddick • Oct. 6, 2022
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    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 Karissa Waddick • Sept. 13, 2022
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    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
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    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 Karissa Waddick • Aug. 31, 2022
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    Permission granted by Alvotech. 

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    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
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    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 Karissa Waddick • Aug. 18, 2022
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    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 Karissa Waddick • Aug. 15, 2022
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    Taking probiotics where they’ve never gone before

    How Seed Health is transforming the microbiome therapeutic market with its pharma-focused drug development approach.

    By Karissa Waddick • Aug. 2, 2022
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    Democrats think they've found a balance between drug innovation and pricing negotiation

    A look at Congress’ push to pass drug pricing reform and why the latest attempt could actually succeed.

    By Karissa Waddick • July 26, 2022
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    By the numbers: The rising danger of superbugs

    A look at how the COVID-19 pandemic exacerbated one of the world’s greatest public health concerns.

    By Karissa Waddick • July 20, 2022
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    Pfizer's former R&D head takes on drug pricing misconceptions in new book

    John LaMattina has something to say about the industry — and he hopes patients are listening.

    By • July 19, 2022
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    Making Moves

    Making moves: Agios, BeiGene, Biocom California and more announce new key hires

    The latest executive personnel changes from around the industry.

    By Karissa Waddick • July 18, 2022
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    Q&A

    COVID won't evolve to become 'less deadly' — and RedHill is prepping for the long haul

    RedHill Biopharma’s chief operating officer, Guy Goldberg, says the company’s oral COVID-19 therapy could still be needed on a global scale.

    By Kim Ribbink • July 12, 2022