Featured Articles

  1. Outlook Good For 7 Drugs Up For Q3 Review 8/15/2024

    A total of 24 drugs, devices, diagnostics, and deals are expected to progress in the third quarter of 2024, including approval applications for 17 drugs. The estimated overall likelihood of approval is 90% or higher for seven of those drugs, including revumenib for acute myelogenous leukemia and KarXT for schizophrenia.

  2. Crafting A Successful Clinical Trial Diversity Action Plan 8/15/2024

    Ensure your clinical trial meets FDA diversity requirements by clearly defining your enrollment goals and strategies in a comprehensive diversity action plan.

  3. Cell And Gene Therapy Field Quiet In Q2 8/15/2024

    While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.

  4. Deciphering The FDA's Diversity Plan Updated Guidance 7/16/2024

    Updated FDA guidance from June outlines the format and content of Diversity Action Plans, the products and studies requiring a plan, and the submission process. Learn about the changes and what to expect.

  5. The Promise And Peril Of AI In Clinical Trials 7/16/2024

    In clinical research, as with many industries, AI is met with both excitement and trepidation. The impact of AI and machine learning is starting to be felt across the pharmaceutical industry.

  6. Billion Dollar Blueprint: The Journey To Blockbuster Status 7/16/2024

    The allure of a blockbuster drug lies not only in its ability to generate billions in revenue but also in its potential to spur additional R&D investment.

  7. 10 Ways To Set Up Your Sites For Recruitment Success 7/16/2024

    Selecting the right trial sites is key to success. Choose sites with the right experience, patient population, diversity mix, and timelines. See these nine tips to boost recruitment and retention.

  8. Including Diversity At The Onset 6/13/2024

    Designing a clinical protocol that is fit for purpose can incorporate diversity into clinical trial planning early on. Explore strategies for incorporating diversity into clinical planning and study protocols.

  9. Cell And Gene Therapy Field Gains Momentum 6/13/2024

    Discover how the dynamic growth trajectory of this field underscores its potential to revolutionize medicine and deliver innovative treatments to patients worldwide.

  10. Completed Clinical Trials, Terminations Both Rose In 2023 6/13/2024

    This white paper highlights how the widespread growth in completed trials is coupled with higher success rates across multiple therapeutic areas, signaling the end of pandemic-related disruptions and infectious disease-related activity after three years of fluctuations.