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Continued process verification ensures pharmaceutical manufacturing stays in control through data analysis, trend detection, and lifecycle monitoring.

SynaptixBio CEO Dan Williams notes how rare-disease drug development is advancing on the back of FDA incentives, priority review vouchers, and a growing recognition of unmet needs.

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

Benjamin McLeod and Sebastian Lykke Skafte Andersen go behind the headlines to examine the motivations behind recent M&A activity, tariff responses, and more.

In partnership with AstraZeneca, the company previously announced approval by FDA in January 2025 for the same indications.

The agreement expands researcher access to backbone modifications that boost stability and delivery of RNA therapeutics across diverse applications.

Using solid- or liquid-phase peptide synthesis or hybrid approaches, Snapdragon can now support peptide projects from development to GMP manufacturing.

VeonGen provided the first update to its lead investigational gene therapy since announcing a company rebrand in June 2025.

Orlynvah is the first new, branded product for the treatment of uncomplicated UTIs to be introduced in the US in more than 25 years.

The agency has completed both pre-license and bioresearch monitoring inspections with no observations, and no safety-related concerns have been raised to date.

Ifinatamab deruxtecan shows promising trial results targeting B7-H3 in small cell lung cancer, offering a potential new option after chemotherapy failure.

Bristol Myers Squibb and SystImmune’s iza-bren shows promising efficacy and safety in EGFR-mutant NSCLC after TKI and chemotherapy, backed by data from global and China-based trials.

The company was one of 17 to receive letters from the White House on July 31 detailing the steps each company must take to bring prescription drug prices down for Americans.

There are no approved therapies for RRP that completely eliminate the need for repeated surgical procedures.

Third-party ICMC certification verifies multi-modality manufacturing readiness, meeting US and EU standards for advanced genetic therapies.

Type 1 diabetes is a lifelong condition that currently affects approximately 400,000 people in the UK.

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.

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.

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

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.