Oral Drug Delivery Articles
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M&A In GLP-1 Technology: Practical Recommendations And Best Practices
11/4/2025
With explosive demand, expanding indications, and rapid innovation, the GLP-1 revolution is reshaping dealmaking. Here's a practical guide for companies negotiating M&A in this arena.
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Drug Delivery Innovation: Getting Advanced Therapies To Patients
11/3/2025
In this article, Fran DeGrazio recounts the evolution of drug delivery technologies as she underscores the need to innovate in the delivery of advanced therapies. Considering chronic diseases, rare diseases, and difficult-to-reach therapeutic targets, Fran offers suggestions for organizing and readying for the development and delivery of platforms, systems, and devices for next generation treatments, including personalized, precision medicines.
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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.
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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.
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Understanding Annex 1 For Sterile Medicinal Products
8/4/2025
In this article, Fran DeGrazio outlines concepts from the EU Annex 1 guidance for sterile medicinal products. She highlights key considerations for the manufacturing of sterile products and offers recommendations for contamination control, facilities upgrades, quality risk management, testing, inspections, and personnel training.
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New Regulatory Considerations For Animal Testing And The Consequences For Drug Product Formulation Development
7/3/2025
The U.S. is experiencing a shift in the regulatory environment for animal testing, driven by the evolving use of AI. This impacts the formulation development approach for new drugs in the non-clinical phase.
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Drug Delivery Innovation: If You Build It, Will Anyone Care?
7/1/2025
In this article, Fran DeGrazio explains why innovation in drug delivery technologies may not need to be revolutionary, but will no doubt need patient adoption, payor support, and regulatory follow-on to become sticky in the marketplace.
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Sorriso's Path To Oral Biologics Dosing Is Through The Gut
6/30/2025
Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.
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From Matrix To Medicine: New Frontiers In Treating Pulmonary Fibrosis And PH
6/25/2025
Halo Biosciences is building a pipeline based on novel insights into how extracellular matrix dysregulation drives disease. We caught up with its leaders to discuss their approach to drug targeting and early development.
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Formulation Development Of A JAK1 Inhibitor Extended-Release Tablet
6/19/2025
This scientific article presents a summary of the formulation development strategy of a JAK1 inhibitor extended-release tablet, with a focus on experimental design, data interpretation, and formulation decision-making.