Featured Pharma Online Editorial

  1. Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture 9/13/2023

    Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern. 

  2. An Overview Of The 9 FDA Special Designations For Pipeline Drugs 9/8/2023

    The FDA employs special designations to streamline and incentivize the advancement of drugs addressing medical gaps. Some designations can accelerate FDA timelines for NDAs and BLAs, others may abbreviate the duration of clinical trials. What scenarios or drugs/therapies are best suited for each?

  3. Respiratory Viral Infections: The Next Frontier For Antiviral Drug Development 8/29/2023

    There is still no approved antiviral therapy for adults with RSV infections. As drug developers, we need to prioritize developing new antiviral therapies for immunocompromised patients.

  4. Navigating The Murky Waters Of Patent Claims Involving AI After Amgen v. Sanofi 8/24/2023

    In May 2023, the Supreme Court issued a ruling on the Section 112 enablement requirement for patents in Amgen v. Sanofi. What does this mean for patent claims involving artificial intelligence (AI) going forward? These Haynes Boone attorneys explain.

  5. Are KRAS Inhibitors Poised To Cure Cancer? 8/21/2023

    The KRAS gene, a crucial component of cell signaling pathways involved in cell growth and division, is frequently mutated in various cancers. By targeting the gene, KRAS inhibitors aim to block the aberrant signaling that promotes cancer cell proliferation. Amgen's sotorasib became the first approved KRAS inhibitor, opening up an exciting field.

  6. The ADC Market To Triple By 2030, Driven By Big Pharma Developments 8/8/2023

    After two decades of trial and error in antibody–drug conjugates (ADC) development, the field is poised to deliver a plethora of targeted drugs to treat a wide range of tumor types. Let's take a look at new market research and some notable recent developments in the space.

  7. 4 Tips To Leverage Your Ingredient Supplier For Faster Formulation 8/3/2023

    Speed to formulation plays a critical role in recouping the investment for a new drug. Many ingredient suppliers have an experienced analytical group and material scientist group, and drug developers should reach out and leverage that expertise with these four strategies.

  8. 5 Promising Applications Of RNA Therapeutics 7/28/2023

    Ribonucleic acid (RNA), once considered a mere messenger molecule, has now emerged as a versatile tool in the development of novel therapies. In this article, we will delve into the world of RNA therapeutics, exploring their potential and five applications that could impact the future of medicine.

  9. Targeting RNA With Small Molecules 7/25/2023

    Beyond mRNA's dogmatic role as the intermediate in gene expression, non-coding RNA play essential roles in transcription regulation, maturation, and translation. This article explores the potential of RNA as a clinically validated avenue for drug development, methods for design and discovery, and implications for the future of medicine.

  10. Preparing A Framework For Artificial Intelligence And Machine Learning Validation: A 3-Step Approach 7/20/2023

    Experts say it would be foolish to ignore the impending AI/ML revolution. There's official guidance out there now on how to prepare, but waiting for a full framework from regulators would be a mistake. This article lays out some strategies for building a foundation to implement AI/ML into your processes.