• 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

    FTC wades into dispute between Supernus, generic competitor

    The agency, which is taking a closer look at the pharma industry, submitted a brief to federal court in a case it says could have “significant implications” for Parkinson’s patients.

    By Kristin Jensen • March 22, 2023
  • Pear Therapeutics prescription digital therapeutic Somryst for chronic insomnia
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    Permission granted by Pear Therapeutics

    Pear, tight on cash, considers strategic alternatives

    The digital therapeutics firm is considering a sale, merger or other deal following struggles to market its app-based treatments.

    By Elise Reuter • March 17, 2023
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    iStock via Getty Images

    VA to cover Leqembi for veterans with early Alzheimer’s

    The agency’s decision on Eisai and Biogen’s new drug contrasts with a stringent Medicare policy that limits coverage to patients in clinical trials.

    By March 14, 2023
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    Permission granted by Amylyx Pharmaceuticals
    ALS drug development

    Amylyx’s ALS drug sales impress Wall Street

    In its first full quarter on the market, Amylyx’s Relyvrio generated nearly $22 million in revenue, or about five times what some analysts forecast last month.

    By March 13, 2023
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    Courtesy of U.S. Food and Drug Administration

    FDA clears first at-home flu and COVID test, days after its developer files for bankruptcy

    The test’s maker, Lucira, said the agency’s “protracted” authorization process caused it to miss out on test sales in the latest flu season.

    By Nick Paul Taylor • Feb. 27, 2023
  • A vial of Eisai and Biogen's Alzheimer's disease drug Leqembi
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    Courtesy of Eisai

    Medicare maintains limits on Eisai’s new Alzheimer’s drug

    Eisai and Biogen have data showing Leqembi slows cognitive decline, but CMS won’t budge until FDA converts its approval from accelerated to full.

    By Feb. 23, 2023
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    Doctors largely comfortable with biosimilar drugs, but question economics: report

    Weeks after the first Humira copycat launched in the U.S., a survey by Cardinal Health suggests insurer mandates will drive biosimilar adoption.

    By Feb. 22, 2023
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    Courtesy of GSK

    GSK wins full approval for cancer immunotherapy, looks to expand use

    The drugmaker converted Jemperli’s accelerated approval in endometrial cancer, while outside advisers endorsed its plan to study the Keytruda rival in rectal tumors.

    By Feb. 10, 2023
  • A photograph of a box of Amylyx Pharmaceuticals' ALS medicine Relyvrio
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    Permission granted by Amylyx Pharmaceuticals
    ALS drug development

    Cigna restricts coverage of new ALS drug, deepening fears about access

    The health insurer’s national formulary considers Amylyx Pharmaceuticals’ Relyvrio to be "experimental, investigational or unproven for any use,” and now does not recommend covering it.

    By Feb. 7, 2023
  • Vials of Eisai and Biogen's new Alzheimer's drug Leqembi
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    Courtesy of Leqembi

    Eisai gives first glimpse into Alzheimer’s drug launch

    In the month since its U.S. approval, Leqembi has had its first sale, its first prescription written and its first administration to a patient.

    By Feb. 6, 2023
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    Courtesy of Roche

    Roche writes off $3B on lower sales forecasts for gene therapies, cancer drugs

    Among the drugs Roche recorded impairment charges on are four gene therapies acquired in the company's 2019 deal for Spark Therapeutics. 

    By Feb. 3, 2023
  • Lilly reports fast sales for new diabetes drug

    Still, fourth quarter sales for Mounjaro were slightly below high Wall Street forecasts and didn’t offset falling revenue from Lilly’s COVID-19 antibodies. 

    By Updated Feb. 2, 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

    Court rules for drugmakers in 340B fight over contract pharmacies

    The decision is a win for Sanofi, Novo Nordisk and AstraZeneca. The drugmakers sued HHS after regulators ordered them to stop restricting sales of 340B drugs to contract pharmacies.

    By Rebecca Pifer • Jan. 31, 2023
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    Amgen Inc.
    Patent thickets

    Humira biosimilars arrive in the US, as Amgen launches first copycat to AbbVie’s blockbuster drug

    The world’s best-selling drug will face pricing pressure as rivals try to steal share from AbbVie’s $20 billion-a-year flagship product in the U.S. 

    By Jan. 31, 2023
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    Jonathan Gardner / BioPharma Dive

    BeiGene wins expanded approval for leukemia drug, intensifying battle with AbbVie, AstraZeneca

    The drugmaker hopes Brukinsa’s survival data will help its drug compete with Imbruvica and Calquence.

    By Jan. 20, 2023
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    Sponsored by Kwello by Acceleration Point

    How social listening can boost your Medical Affairs strategy for 2023 and beyond

    Digital innovation continues to transform the healthcare and biopharmaceutical landscape, and as it does, the role of Medical Affairs is changing.

    Jan. 17, 2023
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    Patent thickets

    Looking past Humira, AbbVie boosts sales forecasts for successor drugs

    Competition to Humira will weigh on AbbVie, but the pharma has laid out ambitious expectations for fast growth from its medicines Skyrizi and Rinvoq.

    By Jan. 11, 2023
  • Pharma companies boost drug prices to start year, but hikes lag inflation

    Analysts noted hundreds of list price increases, including dozens by Pfizer. Many checked in around 5%, roughly in line with hikes taken in recent years.

    By Jan. 3, 2023
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    European regulators back hemophilia gene therapy

    The EMA’s drug review committee recommended five new drugs be approved in Europe during its December meeting, including CSL’s Hemgenix, AstraZeneca’s Imjudo and Amicus’ Pombiliti.

    By Dec. 16, 2022
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    Photo: Will Warasila for Industry Dive

    Deep Dive // ALS drug development

    For ALS patients, doctors, a new medicine reignites concerns about healthcare access

    Relyvrio, a drug developed by Amylyx Pharmaceuticals, is in high demand in ALS clinics across the U.S. Though some patients are already getting it, insurance coverage and out-of-pocket costs remain a source of anxiety.

    By , Dec. 15, 2022
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    Gene therapy approval won, Bluebird takes on next challenge: selling it

    The biotech is still waiting to treat its first commercial patient with Zynteglo, but says it has not seen insurers deny coverage for the beta thalassemia drug.

    By Dec. 12, 2022
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    Sponsored by First Republic Bank

    Life science investment outlook: thinking beyond the pandemic

    Learn about the investment landscape for life science companies, heading into 2023.

    Dec. 12, 2022
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    Ivan-Balvan via Getty Images

    Esperion, without data, says cholesterol pill lowered heart risk in study

    The large cardiovascular outcomes trial is a major test for Esperion, which has struggled to sell its drug Nexletol since winning U.S. approval in 2020.

    By Dec. 7, 2022
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    Courtesy of GSK

    GSK to pull blood cancer drug from US market after study failure

    The British drugmaker has begun the process of withdrawing its multiple myeloma treatment Blenrep following a request from the FDA.

    By Nov. 22, 2022
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    Drazen_ via Getty Images
    Sponsored by Ogilvy Health

    How brands can tap into wellness – lessons from influencers

    Our latest research uncovers new insights on how brands can truly close the wellness gap and grow within their industry sectors.

    By Marion McDonald, Managing Director, Ogilvy Health • Nov. 21, 2022