Featured Editorial

1. Video Spotlight: Where Science Meets Magic with MIT Institute Professor Robert S. Langer 10/29/2025

   Drug Discovery Online interviews MIT’s Bob Langer on biomedical innovation, personalized medicine, longevity, and entrepreneurship—highlighting his journey, lab impact, and personal discipline.

2. Developing Exosome-Based RNA Therapeutics For CNS Regeneration 10/24/2025

   Inside the effort to use exosomes as natural nanocarriers that deliver RNA therapeutics safely across the blood–brain barrier to heal damaged neural tissue.

3. CMC For Long-Acting Injectables For TB 10/3/2025

   Long-acting injectables are a potential treatment alternative for tuberculosis, but they require key development considerations from a chemistry, manufacturing, and controls perspective.

4. Drug Delivery Product Strategy: Aligning The Organization For Execution 10/1/2025

   In this article, Fran DeGrazio offers recommendations to biopharmaceutical sponsor companies about best practices for aligning strategic product initiatives with functional area execution. She outlines 5 key considerations, illustrated with the increasingly common market strategy expansion from drug product development to drug-device combination product delivery.

5. EU MDR: When Products Without An Intended Medical Purpose Meet Medicinal Substances 9/24/2025

   One major change introduced by the EU MDR compared to the former European directives is the inclusion of products without an intended medical purpose but with similar risk profiles to medical devices, such as dermal fillers.

6. The Companion Diagnostic Strategy That Combination Product Leaders Need 9/17/2025

   In the U.S., the Office of Combination Products assigns primary jurisdiction for in vitro diagnostics (CDER, CBER, or CDRH). This article shares regulatory and commercial considerations.

7. Beyond The Inhaler: Expanding COPD Care With Nebulized Combination Therapy 9/3/2025

   Seventy-five percent of COPD patients can't use inhalers properly — yet all therapies rely on handheld devices. Nebulized combinations could bridge this gap for those who need it most.

8. 7 Management Strategies For Combination Product Regulatory Success 9/2/2025

   In this article, Fran DeGrazio lays out best practices for biopharma executive leadership and non-technical managers to sustain regulatory momentum for their combination product development and commercialization. Fran points to cross-functional collaboration, quality management systems, regulatory documentation, and post-market surveillance as keys to drug delivery product success. 

9. Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation 8/21/2025

   The FDA has become more vigilant about alcohol-induced dose dumping in extended-release oral dosages. Such dumping can result in anything from reduced therapeutic effects to dangerous toxicity. Let's take a closer look.

10. Improving Drug-Device Combination Product Co-Development 8/8/2025

    Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated.