Policy & Regulation: Page 10


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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
  • 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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    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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    Trendline

    Commercialization, marketing and social media

    As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical. 

    By PharmaVoice staff
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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
  • Two packets of pills and a vaccine vials sit atop a blue surgical mask.
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    Anna Kim via Getty Images
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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
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    Why a 'fundamental shift' in regulatory submissions is on the way

    Deloitte's senior manager of R&D and regulatory practices explains how technology and strategy must converge to smooth out the bulky drug approval process.

    By July 11, 2022
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    Q&A

    The CEO of Dr. Reddy's N. America is using 'controlled explosions' to keep the generics giant growing

    Marc Kikuchi weighs in on the company’s plans to pump up its pipeline and sales in the coming years.

    By July 7, 2022
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    Permission granted by David Ross/Seqirus. 

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    Dave Ross of Seqirus talks 'milestone' influenza vax vote

    In a unanimous decision, a CDC committee calls for a preferential flu vaccine recommendation for people aged 65 and older for the first time. 

    By Alexandra Pecci • July 5, 2022
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    The oncology market is surging despite a decline in routine screenings

    A new report from IQVIA reveals the current challenges — and promise — in cancer drug R&D.

    By Kelly Bilodeau • June 28, 2022
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    #DIA2022: Building 'guardrails' in the FDA's accelerated approval program

    Regulatory experts weigh in on ways to enhance the controversial drug approval approach.

    By Karissa Waddick • June 21, 2022
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    TikTok tutorial: How pharma can embrace the video platform's educational potential

    Ogilvy Health’s director of social strategy, Katie Ferrigno, busts myths and provides tips on how biopharmas can take advantage of TikTok’s unique features to connect with patients.

    By Karissa Waddick • June 15, 2022
  • Merck director of clinical trial patient diversity Adrelia Allen
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    As cancer innovations thrive, patient access is the next piece of the puzzle

    Why enhanced clinical trials and diagnostics are keys to boosting patient access to cancer care.

    By June 8, 2022
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    Aduhelm's Medicare woes leave questions about lofty premiums

    A single drug’s effect on the premiums that Medicare beneficiaries pay is raising questions about how these levels are set and what factors play a part.

    By Kelly Bilodeau • June 2, 2022
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    SIGA prepares to kick production for monkeypox treatment into high gear

    ‘We’re not bored,’ the company’s science chief says as SIGA Technologies looks to ramp up supplies of its therapeutic.

    By May 31, 2022
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    PBMs under fire for drug prices defend their worth

    A new Senate bill is putting PBMs in the crosshairs of lawmakers — but they argue that they're more than just middlemen.

    By May 26, 2022
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    Q&A

    The UK-based company that's striving to overcome the limitations of T cell receptor innovation

    Etcembly’s CEO, Michelle Teng, shares why a platform approach to T cell receptors can advance and democratize innovation.

    By Kim Ribbink • May 23, 2022
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    A potential COVID-19 EUA could turn this small biotech into a household name

    Veru’s CEO discusses the impact of the upcoming FDA decision on its treatment targeting severely ill COVID-19 patients.

    By May 19, 2022
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    Q&A

    Ironwood Pharmaceuticals is charting a course to become a giant in GI

    Ironwood’s CEO, Tom McCourt, discusses the company’s strategy for leveling up in the GI market. 

    By Karissa Waddick • May 19, 2022
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    Q&A

    BriOri BioTech sets the stage for the comeback of Vioxx

    With a topical pain-relieving ointment in development, the emerging biotech is aiming to give the tarnished NSAID a new life.

    By Kelly Bilodeau • May 17, 2022
  • A doctor holding tablets of medicine explains options to a patient in a hospital room.
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    It's time to acknowledge access as a prescribing barrier

    A new survey reveals how red tape limits patient access to doctor-preferred specialty drugs. 

    By Karissa Waddick • May 11, 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
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    FDA draft guidance may turn diversity in clinical trials from nice-to-have into a must-have

    New guidance from the FDA will ‘up the ante’ for diversity considerations. Here’s how your company can prepare.

    By Kelly Bilodeau • May 10, 2022