News|Videos|November 5, 2025

Top 10 Questions from CPHI Frankfurt: Building Pharma Resilience a Common Theme

Digital transformation, data integrity protocols, and regionalized supply chains are crucial strategies for optimizing drug development and manufacturing efficiency, as revealed in our exclusive interviews.

A pharmaceutical industry in flux was the picture in focus at CPHI Frankfurt 2025, with industry leaders navigating the rapid acceleration of artificial intelligence (AI) integration, profound shifts in global supply chain management, and the imperative for sustained innovation in both formulation and manufacturing processes.

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Shift to In Vivo CAR T Will Reshape Facility Design, Says Arcadis’ Emily Heffernan

Emily Heffernan of Arcadis explains how facility scale, equipment, containment, and quality testing differ across ex vivo cell therapy, viral vector, and mRNA-LNP manufacturing.

October 15th, 2026

Rare Pediatric PRVs: Manufacturing Strategies for Expedited Approval, Part 1

Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.

October 13th, 2026

FDA’s ARC Program Highlights Opportunities and Limits of Bayesian Methods in Rare Disease Trials

Dr. Paz Vellanki discusses Bayesian methods, challenges in developing rare disease endpoints, and why sponsors should engage FDA early in clinical development.

October 9th, 2026

How Surrogate Endpoints Are Shortening Multiple Myeloma Drug Timelines

Bristol Myers Squibb's Nathan Pennell explains how the MRD endpoint supports accelerated approval in multiple myeloma without changing how clinicians monitor patients.

October 16th, 2026

BioPharm Brief: Gene Therapy Progress, FDA Approval, and $103M Funding

Opus Genetics reports sustained vision gains with gene therapy, the FDA approves Roche’s Enspryng for at-home treatment of thyroid eye disease, and Estuary Biotherapeutics launches with $103 million to develop gene therapies for polycystic kidney disease.

Two researchers in lab coats, safety glasses, and blue gloves review data on a computer monitor in a laboratory, with racks of sample tubes and a microscope on the bench and a third researcher working in the background. | Image Credit: © DC Studio - stock.adobe.com

October 16th, 2026

FAQ: When Big Pharma Drops a Drug Candidate, Who Picks It Up?

When large pharmaceutical companies deprioritize drug candidates, smaller developers may license or acquire them, but due diligence, deal structure, and trial planning determine whether a program can move forward.

Close-up of a person’s eye with a hazel-green iris during an eye examination, with a beam of orange light falling across the eyelid and a white instrument forehead rest visible at the top of the frame. | Image Credit: © bradleyblackburn - stock.adobe.com

October 16th, 2026

Opus Genetics’ OPGx-LCA5 Gene Therapy Shows Sustained Vision Gains Ahead of Phase 3

Interim phase 1/2 data presented at Retina in Rio 2026 showed sustained visual improvements with Opus Genetics’ AAV8 gene therapy OPGx-LCA5 and improved retinal sensitivity with OPGx-BEST1 in inherited retinal diseases.

Close-up photograph of a wide-open human eye with a blue-gray iris flecked with gold, a dark pupil, and visible upper and lower eyelashes. | Image Credit: © bradleyblackburn - stock.adobe.com

October 16th, 2026

FDA Approves Roche’s Enspryng as First At-Home Subcutaneous Treatment for Thyroid Eye Disease

The FDA approved Roche's satralizumab (Enspryng), an IL-6 receptor-targeting monoclonal antibody, for adults with thyroid eye disease based on the Phase 3 SatraGO-1 and SatraGO-2 trials, giving patients the first at-home subcutaneous treatment option.