Policy & Regulation: Page 8


  • Young people sitting on the stairs and using smartphones.
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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
  • 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
  • drug shopping cart Explore the Trendline
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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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    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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    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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    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
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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
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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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    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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    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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    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
  • Dr. Robert Califf stands during a congressional hearing
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    Win McNamee / Staff via Getty Images
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    Marking one year as FDA commissioner, Califf lays out vision for agency’s future

    Califf outlined hopes to address advisory committees, drug pricing, digital health and more.

    By Karissa Waddick • Feb. 16, 2023
  • Kinnari Patel Rocket Pharmaceuticals
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    Permission granted by Kinnari Patel Rocket Pharmaceuticals
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    Q&A

    Rocket Pharmaceuticals is ready for liftoff in the rare disease space

    With two rare disease products on the launch pad for FDA submission in 2023 and a growing pipeline, Rocket is fueled for its next era of growth.

    By Feb. 10, 2023
  • FDA commissioner testifying to Congress
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    Kevin Dietsch via Getty Images
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    3 ways the FDA’s restructuring plan could impact pharma

    FDA’s food program is in for a major overhaul — here’s why pharma should pay attention. 

    By Karissa Waddick • Feb. 9, 2023
  • Professional headshot of Tamar Thompson
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    Permission granted by Alexion
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    Profile

    United by inequity: The healthcare disparities plaguing rare disease patients and Black Americans

    Guided by her personal experiences, Tamar Thompson is aiming to improve rare disease care through her advocacy work at Alexion, AstraZeneca Rare Disease.

    By Alexandra Pecci • Feb. 7, 2023
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images
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    Making Moves

    Roche, Chiesi and the FDA change major leadership roles as they strive for growth in 2023

    From Roche’s new pharma chief to the departure of the FDA’s gene therapy head, these moves are bound to shake up the industry.

    By Karissa Waddick • Feb. 6, 2023
  • The Federal Trade Commission headquarters is pictured in Washington, D.C. The agency's proposed noncompete ban may face legal challenges on several grounds.
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    RiverNorthPhotography via Getty Images
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    Antitrust watchdogs have pharma in their sights, and the landscape is getting thornier

    The FTC and DOJ are heightening antitrust enforcement, and pharma deals are a prime target.

    By Karissa Waddick • Feb. 2, 2023
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    Vaxxinity eyes global COVID-19 vaccine market with ‘next-gen’ booster

    The biotech aims to complete rolling submissions with regulators in the U.K. and Australia in the first half of 2023.

    By Alexandra Pecci • Jan. 31, 2023
  • 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
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    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
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    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
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    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