Manufacturing


  • Image attribution tooltip
    Novo Nordisk

    Novo Nordisk to boost drug manufacturing in Denmark

    The Danish drugmaker has invested heavily in expanding its production capacity for oral and injectable drugs. A new $744 million project is the latest investment.

    By Nov. 22, 2022
  • Close chemist scientist holding sample examining.
    Image attribution tooltip
    Permission granted by MMIT
    Sponsored by MMIT

    Integrating lab data into your physician engagement strategy: 5 key benefits

    Normalized lab data can help pharma companies promote their therapies to a targeted audience. 

    By Ritupriya Yamujala • Nov. 14, 2022
  • Workers in cell therapy lab
    Image attribution tooltip

    Copyright © 2022 Miltenyi Biotec B.V. & Co. KG. All rights reserved.

    Sponsored by Miltenyi Biotec

    Modular plug-and-produce facilities for cell therapies

    Commercial-scale production is pivotal for the success of cell therapy. Is modularity the solution?

    Nov. 7, 2022
  • A window with the logo for Amicus Therapeutics.
    Image attribution tooltip
    Amicus Therapeutics

    FDA again delays review of Amicus rare disease drug

    For the second time this year, the agency has put off a decision on Amicus' therapy for Pompe disease. European regulators are also reviewing the treatment and could soon issue an opinion.

    By Oct. 31, 2022
  • Sponsored by Emergent Biosolutions

    The demand for nanoparticles in drug formulation is rising

    Collaborating with an experienced partner, such as a Contract Development & Manufacturing Organization (CDMO), could prove to be invaluable in developing nano-based systems.

    By Kate Silver • Oct. 17, 2022
  • Lab equipment
    Image attribution tooltip
    Permission granted by Aldevron
    Sponsored by Aldevron

    Expediting IND applications with drug master files

    By taking advantage of pre-filed DMFs, researchers benefit from the value, time savings and reduced complexities of having someone else do the heavy lifting for key components of the final drug product.

    Oct. 10, 2022
  • Image attribution tooltip
    Jacob Bell / BioPharma Dive

    Merck expands Singapore hub to support Keytruda, Gardasil

    The company opened a packaging facility for its two top-selling products and began work on a plant that will produce next-generation inhalers.

    By Oct. 6, 2022
  • Image attribution tooltip
    Thomas Lohnes via Getty Images

    BioNTech to build an mRNA hub in Australia

    A new agreement with the Australian government will bring messenger RNA research and manufacturing capabilities to the country, adding to the COVID-19 vaccine developer’s global expansion efforts. 

    By Oct. 6, 2022
  • A sign with the logo for the Takeda pharmaceutical company.
    Image attribution tooltip
    Stock via Getty Images

    Takeda to stop making parathyroid drug Natpara in 2024 after production challenges

    The Japanese drugmaker said it was unable to resolve manufacturing problems that led to a 2019 recall of the drug, which treats hypoparathyroidism.

    By Oct. 4, 2022
  • Women in testing lab
    Image attribution tooltip
    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
  • Image attribution tooltip
    Novartis

    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
  • Image attribution tooltip
    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.
    Image attribution tooltip
    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.
    Image attribution tooltip
    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
    Image attribution tooltip
    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
  • Image attribution tooltip
    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
  • Image attribution tooltip
    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
  • A piece of DNA stretches vertically along a plain background.
    Image attribution tooltip
    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
  • Image attribution tooltip
    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
  • Image attribution tooltip
    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
  • Image attribution tooltip
    Novartis

    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
  • Image attribution tooltip
    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
    Image attribution tooltip
    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
  • A photo of Sanofi headquarters in Paris, France.
    Image attribution tooltip
    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
  • Image attribution tooltip
    Novartis

    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