The Phase 2 trial failure highlights the need for Biopharma to optimize R&D, ensure manufacturing resilience, and adapt to evolving regulations.

Dan Williams, PhD, SynaptixBio CEO, discusses how rare disease drug development leverages genetic targeting and drives innovation and investment in pharmaceutical technology and precision medicine.

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

The Hopewell, N.J., site adds scalable, end-to-end viral vector production with integrated quality systems to speed clinical and commercial gene therapy programs.

Strand advances targeted mRNA therapies, with Phase I STX-001 solid tumor data presented at the 2025 ASCO Annual Meeting.

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

The newly launched facility is located in The Woodlands, Texas, and will produce plasmid DNA as well as strengthen biopharma supply chains.

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

Surveyed by PharmTech Group, this collection of industry players offers their thoughts on HHS’ latest policy move.

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

The additional approval expands the label for Avtozma (tocilizumab-anoh) to now include the treatment of cytokine release syndrome, which aligns the therapy with all indications for which Actemra is approved in the US.

Solutions are emerging to manage advanced modalities and evolving regulatory requirements for viral clearance.

Biopharma’s future depends on seamless integration of technology, expertise, and strategy.

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.

The acquisitions include three testing laboratories that enhance Normec’s ability to serve key highly regulated sectors in the TICC industry.