Featured Pharma Online Editorial

  1. FDA Finalizes Guidance On Nonclinical Evaluation Of Pharmaceutical Immunotoxicity 7/18/2023

    The FDA has now finalized a guidance document on the immunotoxic potential of pharmaceuticals. The FDA builds on current ICH guidance and proposes a two-stage approach. Central to the guidance is using a risk framework.

  2. Using AI In Drug Discovery Isn't The Golden Solution You Think It Is — Yet. 7/17/2023

    Before we realize the true potential of advanced artificial intelligence (AI) and machine learning (ML) technologies to treat disease, we need to start by developing technologies that can generate the massive amounts of reliable, high-quality biological data that make up the fundamentals of any AI/ML approach.

  3. How Is The Future Of Nuclear Medicine Evolving? 7/13/2023

    Nuclear medicine, with its fusion of medical imaging and therapeutic techniques, is reshaping the way diseases are diagnosed, treated, and managed. Let’s look at key market drivers, market restraints, and emerging trends and technologies.

  4. Protein Degraders: Progress, Limitations, & Future Directions 7/12/2023

    There is great excitement surrounding the development of small molecules that trigger the degradation of proteins. This article will highlight proteolysis targeting chimeras (PROTACs), their current limitations, and the emerging strategies to address those limitations, resulting in a bright future for targeted protein degradation.

  5. Patenting Functionally Claimed Biological Compounds After Amgen V. Sanofi 7/10/2023

    Snell & Wilmer attorneys discuss the recent SCOTUS decision to uphold the Federal Circuit's holding that Amgen’s patent claims for functionally claimed antibodies were invalid for failing to meet the enablement requirement. The attorneys share what this means for the industry going forward.

  6. Targeting SORT1 To Drive Peptide–Drug Conjugates In Oncology 7/3/2023

    Peptide-drug conjugates — therapies that generally employ a cleavable or non-cleavable linker to attach a receptor-targeting peptide to a drug payload — have emerged as a potentially viable modality for targeted cancer treatment. How do they work? And how is the glycoprotein SORT1 one of the most promising targets?

  7. The Digital Future Of CMC Regulatory Affairs 6/23/2023

    This article discusses recent initiatives from the FDA, such as KASA, PQ/CMC, and the ICH SPQS. Let's look at how they could be the early birds of the paradigm shift from electronic CTDs to digital CTDs. The article also addresses what steps the industry should be taking in parallel with the authorities in preparation for this (very near) digital future.

  8. Lost CMC Data In An ALCOA+ World 6/19/2023

    As technologies advance, the drug/therapy products we make are becoming more complex, and so are their data fingerprints. This article takes a hard look at the way we currently capture and manage chemistry, manufacturing, and controls (CMC) development and manufacturing operations data, and sheds light on how the document-centric mindset of ALCOA+ is not suitable to support the transition to digital CMC and FAIR data management.

  9. The Growing Use Of Antibody Library Technologies In Drug Discovery 6/14/2023

    Antibody library technologies enable the screening and identification of antibodies with desired properties (such as high affinity and specificity) for a wide range of targets, including proteins, peptides, small molecules, and even complex cellular structures. Here are the key emerging trends.

  10. FDA Seeks Input On AI Adoption In Drug Development And Manufacture 6/13/2023

    The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.