Articles by Katie Anderson

  1. From Lab to Plant: Managing Operational Environment During Scale-Up 9/18/2025

    Though these challenges can result from equipment, raw material differences, and process variability, operational environments must be a major focus during lab trials, as Yuhei Yamamoto and his team at Takeda learned in a recent experience.

  2. FDA Cracks Down On GLP-1 Imports 9/11/2025

    GLP-1 bulk drug substances must be detained without physical examination (DWPE) unless they are on a list (Green List) of approved foreign GLP-1 manufacturers.

  3. Oregon Court Upholds Drug Price Transparency Law 9/9/2025

    The law was first enacted in 2018, followed by a lawsuit by Pharmaceutical Research and Manufacturers of America (PhRMA) in 2019, claiming an infringement of free speech for pharmaceutical companies and violation of public property. PhRMA asked the court to bar Oregon from enforcing the law.

  4. 10 Ways To Strengthen U.S. API: Part II 9/4/2025

    We continue the API supply chain conversation, jumping into KSM sourcing and substitution, utilizing idle space and connecting the dots. The road to strengthening the U.S. pharmaceutical supply chain won’t be easy, but it is manageable.

  5. Spray Drying Market Poised To Nearly Double By 2033 9/2/2025

    The growth of the spray drying market is attributed to demand for enhanced stability, bioavailability and solubility of poorly soluble drugs.

  6. 10 Ways To Strengthen U.S. API: Part I 8/29/2025

    Bringing the API supply chain closer to home not only strengthens the supply chain for U.S. drug makers, but it also strengthens the U.S. reserve of critical medicines.

  7. AbbVie Enters Psychedelic Market With Bretisilocin Acquisition 8/28/2025

    Bretisilocin is a next-generation psychedelic compound (5-HT2A receptor agonist and 5-HT releaser) designed to exert a shorter duration of psychoactive experience, while retaining an extended therapeutic benefit

  8. J&J Commits $2 Billion To N.C. Manufacturing Facility 8/21/2025

    J&J’s latest announcement follows its commitment in March to invest $55 billion to support U.S. manufacturing, R&D, and technology over the next four years.

  9. Reimagining Psychedelics: Mental Wellness Without the Roadblocks 8/19/2025

    The rising incidence of mental health disorders brought the mental health benefits of psychedelics back into the spotlight, and we are currently at a watershed moment.

  10. FDA Launches PreCheck Program 8/12/2025

    The program introduces a two-phase approach to enable new U.S. drug manufacturing facilities: The Facility Readiness Phase and the Application Submission Phase.