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    Permission granted by Aldevron
    Sponsored by Aldevron

    Standardized materials: Meeting the demand for gene therapies

    With supply and labor constraints creating backlogged custom-manufacturing schedules, developers have felt the pain in cost and speed to market.

    Sept. 26, 2022
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    Novartis funnels $300M into early biologic drug manufacturing

    The investment is meant to improve Novartis’ capacity for developing and manufacturing biologic medicines that make up a larger share of its pipeline. 

    By Sept. 12, 2022
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    Getty Images

    FDA holds back Alvotech’s Humira biosimilar over manufacturing issues

    The company received a complete response letter, but still expects to win approval of the copycat drug in time to launch it in the U.S. next year.

    By Sept. 6, 2022
  • A rendering of a Sonoma Biotherapeutics research facility.
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    Courtesy of Sonoma Biotherapeutics

    ‘Treg’ startup Sonoma expands with plans for manufacturing plant

    The biotech, launched by immunologist Jeffrey Bluestone, is developing regulatory T cell therapies for autoimmune and inflammatory diseases.

    By Aug. 24, 2022
  • A vial of the Jynneos monkeypox vaccine sits on a table at a vaccination clinic on August 3, 2022 in West Hollywood, California.
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    Mario Tama via Getty Images

    US speeds rollout of monkeypox vaccine, treatment

    The Biden administration next week will provide 1.8 million doses of the Jynneos vaccine and 50,000 courses of antiviral Tpoxx to states and local governments.

    By Aug. 19, 2022
  • A photograph of an infusion bag of Abecma, a CAR-T therapy from Bristol Myers Squibb and Bluebird bio
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    Courtesy of Bristol Myers Squibb and Bluebird bio

    Bristol Myers CAR-T sales rise despite production problems

    Demand has increased faster than Bristol Myers can make Abecma, although the company said supply is improving. A manufacturing issue for Breyanzi, meanwhile, impacted sales. 

    By July 27, 2022
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    Justin Sullivan via Getty Images

    California to manufacture its own insulin, governor says

    Gov. Gavin Newsom announced a $100 million budget to create a production facility and to develop affordable insulin products, saying the medicines’ high cost “epitomizes market failures.”

    By Susan Kelly • July 11, 2022
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    Stock via Getty Images

    Resilience, a well-funded manufacturing startup, joins with the Parker Institute to make cancer drugs

    The unusual biotech, which just raised $625 million earlier this week, will work with the immunotherapy center under a five-year agreement to create and spin off new companies.

    By Kristin Jensen • June 9, 2022
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    Getty / Edited by BioPharma Dive

    Astellas, despite recent setbacks, opens $100M gene therapy plant

    The opening of the plant, which could create more than 200 new jobs, comes on the heels of several significant issues with the company’s most advanced gene therapy program.

    By June 8, 2022
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    Spencer Platt via Getty Images

    Pfizer to invest $120M, add jobs in Paxlovid production push

    After initially struggling to meet demand for Paxlovid, Pfizer is putting significant resources toward expanding an important manufacturing plant in Michigan.

    By June 7, 2022
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    Permission granted by Stevanato Group
    Sponsored by Stevanato Group

    Why choosing the right primary container is crucial

    New mRNA technology: identifying the right drug containment solution is more important than ever.

    May 16, 2022
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    Novartis suspends production of two radiopharmaceutical drugs over quality concerns

    Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily.  

    By May 6, 2022
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    Jacob Bell / BioPharma Dive

    Seagen to expand, add jobs with new cancer drug factory

    While some biotechs are restructuring amid a market downturn, SeaGen plans to add 200 positions through a large manufacturing plant that should be operational in 2024.

    By April 21, 2022
  • A photo of Gilead's cell therapy manufacturing facility in Frederick, Maryland
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    Courtesy of Gilead

    Gilead gets cell therapy boost with FDA clearance of Maryland factory

    The new site in Maryland will be used to produce Yescarta, which this month won an expanded approval that substantially widens its market.

    By April 19, 2022
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    Courtesy of Sanofi

    Sanofi API spinout takes step toward market listing

    French regulators have approved plans by Sanofi to list the new EUROAPI business on Euronext Paris beginning May 6.

    By April 1, 2022
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    Novartis turns cell therapy skill into contract manufacturing deal

    In an unusual arrangement, the Swiss pharma will make Carisma Therapeutics' experimental cell therapy at its Morris Plains factory, part of its plans to build up a CMO business.

    By March 10, 2022
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    Novo Nordisk

    Novo sees fast growth ahead of obesity drugs despite production hurdles

    The Danish drugmaker aims to triple sales of its weight loss treatments Wegovy and Saxenda by 2025. But first, Novo needs to resolve manufacturing constraints that have slowed the former drug's launch. 

    By March 4, 2022
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    Jonathan Gardner / BioPharma Dive

    Atara sells cell therapy plant to Fujifilm for $100M

    The site, which specializes in manufacturing off-the-shelf immunotherapies, was once a key asset for Atara. New owner Fujifilm will still supply the biotech under a long-term agreement.

    By Jan. 27, 2022
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    Sponsored by Nuvolo

    3 ways an IWMS can help streamline your manufacturing operations

    Manage, maintain and optimize all the tasks, duties and goals that fall under the umbrella of your workplace.

    Jan. 24, 2022
  • A photo of Merck & Co. and Ridgeback's molnupiravir being manufactured.
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    Courtesy of Merck & Co.

    Generic manufacturers sign pact to supply Merck COVID pill to lower-income countries

    The licenses will help make molnupiravir available to people in more than 100 countries, giving public health authorities a needed tool despite the drug's limited effectiveness.

    By Jan. 20, 2022
  • Exterior building picture of the Merck KGaA Life Science site in Burlington, U.S.
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    Courtesy of Merck KGaA

    German Merck buys manufacturer of key component in mRNA medicines

    Merck KGaA is buying Indianapolis-based Exelead, a specialist in the lipid nanoparticles used to ferry mRNA into the body, for $780 million in cash. 

    By Jan. 6, 2022
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    Jeenah Moon via Getty Images

    Pfizer opens gene therapy plant in $800M North Carolina expansion

    The new facility cost nearly $70 million to build, and is part of a major push by the pharma giant to become a leader in genetic medicine manufacturing.

    By Kristin Jensen • Dec. 16, 2021
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    Gabriel Kuchta via Getty Images

    Moderna cuts vaccine sales, delivery targets for 2021

    The biotech now expects to deliver between 700 million and 800 million doses this year, down from a previous forecast of 800 million to 1 billion.

    By Nov. 4, 2021
  • A photo of Merck & Co. and Ridgeback Biotherapeutics' molnupiravir being manufactured.
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    Courtesy of Merck & Co.

    Gates Foundation pledges $120M to bring Merck COVID-19 drug to lower-income countries

    Anticipating regulatory clearance of the pill, the group aims to speed access by investing in the manufacturing of generic versions of the drug.

    By Kristin Jensen • Oct. 20, 2021
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    Permission granted by Vetter Pharma
    Sponsored by Vetter Pharma

    Emerging therapeutic oligonucleotides – analytical challenges accepted

    A relatively new class of parenteral drug products on the market - therapeutic oligonucleotides – poses new challenges to the pharmaceutical manufacturing process.

    By Alexandra H. Heussner, Ph. D., Laboratory Manager ASL, and Melanie Zerulla-Wernitz, Ph. D., Head of ASL, Development Service, Vetter Pharma-Fertigung GmbH & Co. KG • Oct. 18, 2021