Industry Insights

  1. What Does FDA's Biosimilar Workload Reveal About Emerging U.S. Market? 3/22/2016

    The FDA has faced questions and criticism over its slow progress with biosimilar-related policies. In the face of these questions, however, the FDA has not provided any estimates or figures about the size of the biosimilars review team or the team's workload. Now, a new review released by ERG breaks down the agency's workload volume and costs, giving clearer insights into how the U.S. regulatory landscape is unfolding.

  2. Supporting Compliance And Reducing Risk In Gene Therapy Logistics 2/4/2025

    Ensure the safe, compliant, and seamless delivery of gene therapies by leveraging advanced logistics solutions designed to meet stringent regulatory standards and mitigate risk at every stage.

  3. Assessing The Impact Of New Equipment On Your CDMO's GMP Operations 12/18/2018

    To a drug sponsor, a CDMO’s new equipment could mean production may be able to start sooner than expected, or it might allow them to continue working with a CDMO rather than switching to another.

  4. Araris Doubles Down With Dual-payload ADC 9/24/2024

    Antibody-drug conjugates usually deliver one payload type, which can overlook cancer’s complexity. A single ADC delivering two separate payloads could be the answer.

  5. Biopharma In China: The Emerging Global Force Of Domestic Suppliers 5/23/2022

    Though multinational corporation vendors have seen double-digit pandemic-related sales increases for bioprocessing supplies in China, the top domestic vendors have posted even higher growth rates. With domestic supplier prices significantly cheaper, quite a few Chinese biopharma companies are shifting their purchase of supplies.

  6. Targeted Protein Degraders: Transforming Oral Therapeutics 8/11/2025

    CDMOs play a critical role in TPD development by offering specialized infrastructure and analytical capabilities to support the transition from preclinical research to clinical supply and commercialization.

  7. How To Measure COVID-19's Impact On Clinical Trials In A Given Country 4/14/2020

    No one knows how the pandemic will unravel and when (if) things will go back to normal. One thing is clear: At least in the next year, research and patient recruitment strategies for current and new clinical trials will depend on the COVID-19 impact on countries and their landscapes. How can we best evaluate what that impact will be?

  8. 3 Steps To Developing Adaptability In Pharma Supply Management 1/23/2023

    Explore three practical steps pharma manufacturers can take today to start modernizing and streamlining their pharma supply management activities and to keep up with new approaches to supplier management.

  9. FDA Releases Guidance On Normal GMP Operations During COVID-19 9/18/2020

    Most FDA guidance on COVID has been associated with tools to combat the pandemic. This new guidance should be read by all drug and biologic manufacturers, whether or not they produce COVID-related products.

  10. Integrating Quality Processes And Documentation After A Merger 4/25/2024

    If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.