Florida’s emergency rule will classify certain concentration forms of 7-hydroxymitragynine opioid products as Schedule 1 controlled substances in Florida, a step FDA recommended for 7-OH opioids in July 2025.

Dave Miller, PhD, explains how a development-first approach, scientific depth, and regulatory trust build lasting partnerships in the CDMO space.

The company’s commitment to its North Chicago, Ill. plant is part of a previously announced $10 billion capital investment earmarked for the expansion of US innovation and manufacturing capacity.

The company is not developing an mRNA vaccine, but had been using one as the control in a 10,000-subject Phase IIb trial.

Dave Miller, PhD, discusses how tailored solutions, trust, and lifecycle planning are redefining partnerships in bio/pharmaceutical development.

The new targeted pipeline will advance Nxera’s oral GLP-1 agonists, novel GPCR targets, and structure-based drug design to address obesity and related health conditions.

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.

FDA reinstates Vinay Prasad to lead CBER as gene therapy safety concerns spotlight regulatory challenges in biotech manufacturing.

New manufacturing methods are being explored, but challenges are still present in personalized medicine development.

Thermoplastic elastomers (TPE) offer a PFAS-free solution for stoppers in parenteral packaging, ensuring a safer and more sustainable product.

For the first target addressed in the partnership, the two companies reported the successful delivery of AI-designed, functional antibody leads.

The company’s expanded label for Avtozma (tocilizumab-anoh) now includes the treatment of cytokine release syndrome, aligning the therapy with all indications for which Actemra is approved in the US.

The agency’s new program is designed to increase regulatory predictability and streamline review of domestic manufacturing facilities.

Experts from LGM Pharma and Rockwell Automation share their thoughts on what makes tech transfer effective, where processes could be improved, and why certain development and manufacturing decisions are so crucially important.

Jonathan D. Grinstein, PhD, Manfred Scholz, PhD, and Erik Wiklund, PhD, go behind the headlines to address a shifting policy landscape and what it means for the future of chronic disease, diagnostics, and next-generation cell and gene therapies.