Manufacturing


  • Glass vials with orange caps sit on a pharmaceutical factory production line.
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    Stock via Getty Images
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    Catalent cuts outlook, delays results as it reveals new hurdles

    The pharmaceutical CDMO said it found “significant” issues with its forecasts over the past year, compounding manufacturing problems at three of its plants.

    By May 8, 2023
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    Tim Boyle via Getty Images
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    Baxter to sell biopharma unit to private equity for $4.25B

    The deal is the latest in a string of private equity-backed deals for contract development and manufacturing businesses in the pharmaceutical sector.

    By Elise Reuter • May 8, 2023
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    Novo Nordisk
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    Obesity drugs

    Novo reveals another setback in obesity drug’s launch

    U.S. supply of Novo’s Wegovy will be “reduced temporarily,” while the Danish drugmaker gets a new contract manufacturer up and running, executives said.

    By May 4, 2023
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    Jeenah Moon via Getty Images
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    Pfizer turns focus to new drugs as COVID vaccine revenue falls

    The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.

    By May 2, 2023
  • Exterior sign of Bristol-Myers Squibb
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    Permission granted by Bristol-Myers Squibb
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    Bristol Myers boosts cell therapy production with Novartis plant

    Accessing the Illinois facility will expand Bristol Myers’ supply of viral vectors following manufacturing struggles with CAR-T drugs Abecma and Breyanzi.

    By Kristin Jensen • April 26, 2023
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    Novartis
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    Novartis plant cleared to produce in-demand cancer drug

    The FDA has approved the pharma, which has had difficulty producing radiopharmaceutical drugs, to make its treatment Pluvicto at a New Jersey site.

    By April 24, 2023
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    Sarah Silbiger via Getty Images
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    FDA again knocks back Alvotech’s Humira biosimilar

    The agency rejected the partners’ copycat version of AbbVie’s blockbuster drug for a second time, citing problems spotted during the inspection of a manufacturing facility.

    By April 14, 2023
  • A flag showing the Sartorius logo is seen in front of a manufacturing plant.
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    Courtesy of Sartorius
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    Pharma partner Sartorius eyes gene therapy market with $2.6B deal

    The biotech tools supplier is acquiring Polyplus, a French company that makes components essential to the viral vector backbones of gene therapies.

    By March 31, 2023
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    LaylaBird via Getty Images
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    Sponsored by MilliporeSigma

    Addressing manufacturing challenges in gene therapy development

    As new gene therapies are developed to treat a growing number of indications, patients may soon have access to novel treatment options and potential cures.

    By Kate Silver • March 20, 2023
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    Permission granted by West Pharmaceutical Services
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    Sponsored by West Pharmaceutical Services

    Early decisions to de-risk the transition to combination products

    Speeding up the drug development process through a less optimized containment and delivery system may have been an option in the past, but both expectations and the competitive environment are changing. 

    March 20, 2023
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    Novartis 

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    Sandoz, betting on biosimilar sales, to build new production plant

    The Novartis division will invest at least $400 million in a new manufacturing facility in Slovenia amid expectations that demand for copycat biologics will surge in the coming years.

    By March 9, 2023
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    Novartis
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    Novartis takes step toward expanding supply of in-demand cancer drug

    The company has struggled to maintain supply of its prostate cancer drug Pluvicto, hampered by production issues and higher-than-expected demand.

    By March 3, 2023
  • Portrait of Boro Dropulić, chief executive officer of Vector BioMed.
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    Permission granted by Vector BioMed
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    A startup launches with plans to open up a gene and cell therapy bottleneck

    The pipeline of CAR-T therapies and ex vivo gene therapies has swelled in recent years, but manufacturing hasn’t been able to keep up with demand.

    By Jan. 31, 2023
  • Lilly to boost diabetes drug production with $450M factory investment

    The pharma aims to double its manufacturing capacity for drugs like Mounjaro and Trulicity as competition with rival Novo Nordisk heats up.

    By Jan. 24, 2023
  • Lab production line of syringes
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    Permission granted by Stevanato Group
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    Sponsored by Stevanato Group

    The inspection challenges posed by the self-administration trend

    Automatic visual inspection: rising to the challenges of syringe inspection. 

    Dec. 19, 2022
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    Novo Nordisk
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    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
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    Permission granted by MMIT
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    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
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    Copyright © 2022 Miltenyi Biotec B.V. & Co. KG. All rights reserved.

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    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
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    Amicus Therapeutics
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    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
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    Permission granted by Aldevron
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    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
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    Jacob Bell / BioPharma Dive
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    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
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    Thomas Lohnes via Getty Images
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    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.
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    Stock via Getty Images
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    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
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    Permission granted by Aldevron
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    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