Policy & Regulation: Page 5


  • Professional headshot of Monica Bertagnolli
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    (2021). Retrieved from NCI.
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    Making Moves

    Biden’s pick to lead the NIH faces an uphill battle

    Pending Senate confirmation, NCI head Monica Bertagnolli will take the helm of the collection of research organizations as it faces increasing bipartisan scrutiny. 

    By Karissa Waddick • May 18, 2023
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    artJazz via Getty Images
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    Major regulatory changes are coming to pharma in the EU — and industry’s weighing in

    The European Union published a long-awaited proposal that could bring sweeping changes to its pharma sector last month, but the legislative fight has only just begun.

    By Karissa Waddick • May 16, 2023
  • digital pill Explore the Trendline
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    Stock via Getty Images
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    Trendline

    Artificial intelligence & machine learning

    After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.

    By PharmaVoice staff
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    Stock via Getty Images
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    Years into the pandemic, only a handful of clinical trials are targeting long COVID — here’s one of them

    Scientists at Stanford are testing Pfizer’s Paxlovid on long COVID symptoms and their efforts could provide clues for other conditions.  

    By Kelly Bilodeau • May 15, 2023
  • Christopher Boone AbbVie
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    Permission granted by Christopher Boone AbbVie
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    Q&A

    AbbVie’s Christopher Boone on RWE’s potential — and its ‘profound ethical dilemmas’

    With decades of experience in public health, Boone is leveraging RWE to move the needle within clinical development.

    By May 10, 2023
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    agrobacter via Getty Images
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    Insulin prices have dropped — will Civica still be a disrupter in the field?

    The nonprofit generics maker still sees a need for low-cost insulin despite recent moves by major drugmakers to slash the prices of their popular products. 

    By Karissa Waddick • May 8, 2023
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    Stock via Getty Images
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    3 key FDA approval trends this year

    Although approvals are off to a slow start in oncology, the agency has been living in the fast lane for neurological disorders and more.

    By Kelly Bilodeau • May 8, 2023
  • Neena Patil Jazz Pharmaceuticals
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    Permission granted by Neena Patil
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    Podcast

    Woman of the Week: Jazz Pharmaceuticals’ Neena Patil

    Patil’s dual interests in healthcare and law are at the intersection of her C-suite role.

    By May 3, 2023
  • An illustration of a globe with large multicolored pins pointing to countries.
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    Stock via Getty Images
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    Taking your biotech global? Here’s how you can navigate cultural norms

    What’s so different about doing pharma business in the U.K. versus Japan? One of Moderna’s top brass shares her tips for navigating choppy cultural waters.

    By Alexandra Pecci • May 2, 2023
  • Preeti Parikh, MD Executive Medical Director GoodRx
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    Permission granted by GoodRx
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    Sponsored by GoodRx

    A physician’s perspective on health equity, diversity and inclusion

    Dr. Preeti Parikh sees parallels between promoting health equity and current DE&I challenges in the workplace.

    By Preeti Parikh, MD, Executive Medical Director, GoodRx • April 24, 2023
  • Young people sitting on the stairs and using smartphones.
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    Stock via Getty Images
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    Patient influencers are here to stay — where are the regulations?

    As social media health influencers enter the world of pharma advertising, experts warn that more guardrails are needed to protect the industry and patients.

    By Karissa Waddick • April 17, 2023
  • COVID vaccine development
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    iStock via Getty Images
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    A new era of COVID innovation is here

    With a $5 billion dollar infusion, a new White House program is helping catalyze development of next-gen treatments, from pan-coronavirus vaccines to enhanced antivirals. 

    By Kelly Bilodeau • April 17, 2023
  • Vaccine
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    David Greedy/Getty Images via Getty Images
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    Fighting vaccine hesitancy may require a new approach from pharma

    The COVID-19 pandemic highlighted an ongoing problem of vaccine hesitancy undermining public health efforts. One way pharmas can help is to change the narrative.

    By April 13, 2023
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    Spencer Platt via Getty Images
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    After working at Merck during the Vioxx scandal, this former sales rep is on a mission to fix the system

    The founder and CEO for the Accreditation Council for Medical Affairs is increasing accountability in pharma by emphasizing training, standards and ethics in medical affairs.

    By Alexandra Pecci • April 11, 2023
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    Stock via Getty Images
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    Opinion

    Leaders wave a magic wand at pharma’s thorniest issues

    The major challenges pharma leaders would solve with a quick flick of an imaginary wand.

    By PharmaVoice staff • March 31, 2023
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    Stock via Getty Images
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    Seamless clinical trials were created to make studies easier — instead, they’ve become more complex

    Experts weigh in on how companies can design better trials that merge two phases into one.

    By March 29, 2023
  • U.S. Supreme Court building
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    Al Drago/Getty Images via Getty Images
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    SCOTUS to decide ‘fundamental change’ in biologics patents with fate of Amgen v. Sanofi

    The Supreme Court will now decide whether Amgen can protect Repatha as a whole class of drugs or whether Sanofi’s rival product Praluent can retain a place in the market.

    By March 28, 2023
  • A person stands outside of a building that says 'Silicon Valley Bank' with their hand on their chin.
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    Justin Sullivan via Getty Images
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    SVB’s collapse had limited impact on biopharmas — but a broader financial crisis could change the landscape

    Although many pharma and biotech companies had deposits at the failed bank, most have reported little to no exposure.

    By March 21, 2023
  • A glass building with a sign that reads,  "Biogen."
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    Paul Marotta/Sipa USA/Newscom

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    Making Moves

    In the fallout from Aduhelm, Biogen’s leadership shakeup continues

    The recent departure of neurodegenerative development head Samantha Budd Haeberlein is just the latest sign of a changing tide among Biogen’s post-Aduhelm leadership.

    By Karissa Waddick • March 16, 2023
  • U.S. President Joe Biden speaking in Philadelphia.
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    Chip Somodevilla/Staff/Getty Images News via Getty Images
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    Biden doubles down on drug pricing in 2024 budget — but boosts R&D

    The president’s 2024 budget proposal expands on last year’s drug pricing reforms, but also dramatically increases innovation investments.

    By Karissa Waddick • March 13, 2023
  • Concept image of insulin aspart with fake labeling
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    Samara Heisz via Getty Images
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    Eli Lilly took price cuts into its own hands. Will other pharmas follow suit?

    The pharma giant took the high road and cut prices before the feds made them. How will that affect the industry?

    By March 7, 2023
  • Colorful medical pills cover Benjamin Franklin's face on one hundred american dollar bill.
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    Stock via Getty Images
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    FDA ups generics and biosimilar approvals for a shot at lower drug costs

    As the Biden administration searched for drug-cost reducing measures, the FDA incentivized generic and biosimilar development in 2022. 

    By Karissa Waddick • March 6, 2023
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    Stock via Getty Images
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    Multimillion-dollar therapies are changing how payers foot the bill

    With more gene therapies headed to market, novel payment methods are emerging from regulators and academia. 

    By Feb. 28, 2023
  • Who is Vivek Ramaswamy — the biotech entrepreneur turned presidential candidate?

    The former CEO of Roivant, who became the face of the “anti-woke” business movement, is now running for the 2024 Republican presidential nomination. Here’s what he stands for. 

    By Karissa Waddick • Feb. 27, 2023
  • Faby Malik Cytokinetics
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    Permission granted by Dr. Faby Malik, Cytokinetics
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    Q&A // Biotech Spotlight

    Cytokinetics looks to muscle into the cardiovascular market

    With a scientific platform based on muscle biology, the late-stage biotech is addressing cardiovascular and neuromuscular diseases.

    By Feb. 24, 2023
  • A statue of a woman holding the balance of justice
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    Stock via Getty Images
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    Why FDA’s approach to orphan drug exclusivity is ripe for more legal challenges

    Despite a court ruling, the FDA is sticking to its narrow orphan drug exclusivity approach. But confusion remains over the policy’s future. 

    By Karissa Waddick • Feb. 23, 2023