Policy & Regulation: Page 7

  • U.S. economy contracted for second consecutive quarter
    Image attribution tooltip
    Baris-Ozer via Getty Images
    Image attribution tooltip

    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
  • A creative image depicting empty voting booths on election day.
    Image attribution tooltip
    adamkaz / iStock / Getty Images Plus via Getty Images
    Image attribution tooltip

    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
  • biotech market Explore the Trendline➔
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip
    Trendline

    Emerging biotech

    After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.  

    By PharmaVoice staff
  • nerve signals in brain
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Sean Gallup / Staff via Getty Images
    Image attribution tooltip

    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
  • A photo of Biogen's Alzheimer's drug Aduhelm
    Image attribution tooltip
    Permission granted by Biogen
    Image attribution tooltip

    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
  • Diane Stroehman pix
    Image attribution tooltip
    Diego Camargo/PharmaVoice
    Image attribution tooltip
    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
  • Medicine bottles
    Image attribution tooltip
    Jackfoto via Getty Images
    Image attribution tooltip

    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
  • A picture of Xavier Becerra giving a speech at a podium
    Image attribution tooltip
    Alex Wong via Getty Images
    Image attribution tooltip

    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
  • A wooden figurine of a business person sits at a higher spot on a table than a series of six other wooden figurines of business people.
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip
    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
  • Dr. Preeti Parikh, executive medical director at GoodRx
    Image attribution tooltip
    Permission granted by GoodRx
    Image attribution tooltip
    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
  • Professional headshot of Erin Duffy
    Image attribution tooltip

    Permission granted by Asia Kepka

    Image attribution tooltip
    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
  • Colonies of bacteria in MacConkey agar
    Image attribution tooltip
    Md Saiful Islam Khan via Getty Images
    Image attribution tooltip

    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
  • Pills
    Image attribution tooltip
    Iryna Imago via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Gabriel Kuchta via Getty Images
    Image attribution tooltip

    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
  • Professional headshot of Róbert Wessman.
    Image attribution tooltip

    Permission granted by Alvotech. 

    Image attribution tooltip

    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.
    Image attribution tooltip
    Drew Angerer via Getty Images
    Image attribution tooltip

    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
  • Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    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
  • A collage of pnk, blue and orange bacteria-like blobs float around against a dark blue background.
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip

    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
  • A view of the Capitol Dome from below with an American flag waving in the wind on the left side and blue skies in the background.
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip

    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
  • A person wearing a purple latex glove holds a petri dish with pink and red spots vertically with their thumb and index finger.
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip

    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
  • John LaMattina
    Image attribution tooltip

    Permission granted by John LaMattina

    Image attribution tooltip

    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
  • A person holds a magnet pointed at multi-colored wooden figures of people sitting on dark wood-grain table.
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip
    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.
    Image attribution tooltip
    Anna Kim via Getty Images
    Image attribution tooltip
    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
  • Business person working at laptop computer and digital documents with checkbox lists.
    Image attribution tooltip
    Galeanu Mihai via Getty Images
    Image attribution tooltip

    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
  • Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip
    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