Pharma: Page 49


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    Mario Tama via Getty Images
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    J&J chief Alex Gorsky to step down early next year

    Citing family health reasons, Gorsky will transition to the role of executive chairman and pass his torch to Joaquin Duato, currently vice chairman of J&J's executive committee.

    By Aug. 20, 2021
  • A building with logo of drugmaker Eli Lilly.
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    Courtesy of Eli Lilly
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    FDA approves Lilly, Boehringer diabetes drug for heart failure

    The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance.

    By Kristin Jensen • Aug. 19, 2021
  • An illustration of beta amyloid plaques and tau in the brain Explore the Trendline
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    National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
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    Trendline

    Alzheimer's disease

    Many companies hope to follow in the footsteps of Biogen, Eisai and Eli Lilly by developing new therapies for the debilitating disease, which affects tens of millions of people and costs healthcare systems hundreds of billions of dollars each year.

    By BioPharma Dive staff
  • GSK, in race to catch up with rivals, wins expanded approval for cancer drug

    The pharma's immunotherapy Jemperli can now be used for a wider array of cancers that are "mismatch repair-deficient," matching an indication held by Merck's top-seller Keytruda.

    By Kristin Jensen • Aug. 18, 2021
  • A building with logo of drugmaker Eli Lilly.
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    Courtesy of Eli Lilly
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    Lilly, preparing Alzheimer's drug plans, forms new neuroscience unit in company restructure

    Lilly Bio-Medicines will be split into separate neuroscience and immunology groups, while the Loxo cancer research division will merge with Lilly Oncology. 

    By Aug. 17, 2021
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    Shaun Anders

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    Sponsored by Scipher

    In RA, new molecular signature test confirms who won't respond to anti-TNF therapy during any point in therapeutic journey

    A new study demonstrates that PrismRA can predict the likelihood of not achieving a clinically meaningful response of at least a 50% improvement in symptoms in targeted therapy-naïve patients. 

    Aug. 16, 2021
  • A podium showing the logo for the Centers for Disease Control and Prevention is seen.
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    Kevin C. Cox via Getty Images
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    CDC advisers back third dose of Pfizer, Moderna vaccines for immunocompromised people

    The advisory panel's vote followed the FDA's authorization last Thursday of an additional dose for people with weakened immune systems. 

    By Shoshana Dubnow • Aug. 13, 2021
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    Alex Wong via Getty Images
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    Biden embraces Medicare drug price negotiation as Democrats seek to widen health coverage

    In a speech Thursday afternoon outlining his proposal, which features several familiar policy ideas, Biden emphasized price negotiation, but allowing for drugmaker profit. 

    By Updated Aug. 12, 2021
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    Getty Images
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    Merck wins approval for Keytruda combo as kidney cancer treatment

    Clinical testing showed a clear benefit to using Keytruda with Merck and Eisai's Lenvima in patients with previously untreated advanced renal cell carcinoma.

    By Kristin Jensen • Aug. 12, 2021
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    Maddie Meyer via Getty Images
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    Eyeing future outbreaks, Moderna partners with Canadian government on vaccine plant

    While Canada has already secured more COVID-19 vaccine doses than it needs, the factory to be built is geared toward combating future pandemics.

    By Aug. 10, 2021
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    Courtesy of Roche
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    Roche sets bar in early lymphoma treatment with Polivy study results

    Positive data for the Swiss pharma's antibody-based drug could be a benchmark for CAR-T therapies, which other developers aim to move into early lymphoma treatment, too.

    By Aug. 9, 2021
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    Bayer AG
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    How Bayer lured a biotech away from an IPO and into a buyout

    Vividion Therapeutics was headed toward an IPO earlier this year, but the company's co-founder said Bayer’s $1.5 billion offer ended up being a more attractive option.

    By Shoshana Dubnow • Aug. 5, 2021
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    Amgen Inc.
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    Amgen, expecting higher demand for its medicines, to build plant in North Carolina

    The biotech is also constructing a new factory in Ohio and, between the two, expects to investment nearly $1 billion over the next few years.

    By Kristin Jensen • Aug. 4, 2021
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    Novartis
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    FDA allows Novartis gene therapy trials to resume after nearly 2 year pause

    After reviewing animal study data submitted by the Swiss pharma, the FDA cleared spinal injections of Zolgensma for study in older patients with SMA.

    By Aug. 3, 2021
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    Christopher Furlong via Getty Images
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    AstraZeneca wins first FDA approval for systemic lupus drug in a decade

    The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.

    By Aug. 2, 2021
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    Permission granted by ZS
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    Sponsored by ZS

    Data is becoming the healthcare ecosystem entry fee

    Biopharmaceutical companies have an opportunity to work alongside new healthcare ecosystem entrants for mutual benefit and better customer value.

    By Pratap Khedkar and Howard Deutsch • Aug. 2, 2021
  • A Pfizer sign on a building.
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    Jeenah Moon via Getty Images
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    Pfizer's fast progress shines spotlight on an emerging vaccine race

    The big drugmaker surprised analysts and investors this week by projecting Phase 3 results next year, which could put the company on pace with a rival shot from GlaxoSmithKline.  

    By July 30, 2021
  • The historic Mylan plant in Morgantown, West Virginia.
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    Permission granted by Albert Haught
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    A pharma merger's impact ripples across West Virginia as Viatris plant closes

    One of the country's oldest and largest drug manufacturing plants shut down Saturday, a consequence of the 2019 merger between Mylan and Pfizer's Upjohn unit. The impact will be felt by a West Virginia city for years to come.

    By Shoshana Dubnow • July 30, 2021
  • AstraZeneca still eyes US vaccine filing despite another delay

    The company now expects to file for full approval by year's end and has a variant-specific shot in advanced testing. But the long-term prospects for AstraZeneca's new vaccine business are unclear.  

    By July 29, 2021
  • 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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    Getty Images
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    In a first, FDA approves an 'interchangeable' biosimilar for diabetes

    An injectable insulin from Viatris has become the first-ever biosimilar product that can be directly substituted for a marketed biologic, a long-awaited decision that could put pricing pressure on other diabetes drugs. 

    By July 29, 2021
  • Pfizer CEO Albert Bourla
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    Drew Angerer via Getty Images
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    Pfizer, responding to criticism, presses case for COVID-19 booster shots

    During an earnings call Wednesday, a preprint paper was released showing a waning effect for the company's vaccine over time, one of a few data points Pfizer executives used to support the need for a booster shot.  

    By Updated July 29, 2021
  • Two test tubes pour different-colored liquids into a beaker in an illustration representative of biopharma mergers.
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    Elizabeth Regan/BioPharma Dive
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    An AstraZeneca spinout scores a buyout option from Arena

    The potential acquisition marks a fast turnaround for Aristea, one of several biotechs formed from programs AstraZeneca decided not to advance internally.  

    By July 27, 2021
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    Justin Sullivan via Getty Images
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    Regeneron, AstraZeneca team up on targeted drugs for obesity

    After screening 650,000 people, Regeneron unearthed a mutation associated with lower weight. AstraZeneca aims to help the biotech make a drug based on its findings.  

    By July 27, 2021
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    Getty Images
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    Merck rebounds to win a milestone immunotherapy approval in early breast cancer

    The FDA reversed an earlier decision to make Keytruda the first immunotherapy available for patients with early-stage breast cancer and also gave the drugmaker a full approval in advanced disease. 

    By July 27, 2021
  • The World Health Organization emblem of a snake symbol for medicine coiling around UN symbol.
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    Sean Gallup via Getty Images
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    BioNTech, WHO hatch plan to bring mRNA vaccines to Africa

    Responding to criticism, the German biotech plans to develop a malaria shot and build manufacturing infrastructure on the continent. 

    By July 26, 2021
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    John Moore via Getty Images
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    Drug distributors, J&J agree to pay $26B in major opioid settlement with states

    The long-negotiated deal could resolve the vast majority of lawsuits against the companies for their alleged role in contributing to the opioid epidemic.

    By Kristin Jensen • July 22, 2021