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The company will be adding a 160,000-square-foot dedicated manufacturing facility at the FUJIFILM site in Holly Springs, NC.

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

Survey responses indicate that bio/pharma faces tariff-driven rising costs and supply strain, with firms aiming to boost compliance and diversification and seeking stable trade and R&D support.

Pharmaceutical Technology® spoke with C. Michael White, distinguished professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and chair of the Kratom Consumer Advisory Council, about recent government actions regarding kratom and concentrated 7-hydroxymitragynine (7-OH) products.

FDA’s recommendation to control 7-OH products under the Controlled Substances Act should help prevent competition between legitimate pharmaceutical medicines and those companies looking to circumvent FDA regulations, says Michael White, Distinguished Professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and Chair of the Kratom Consumer Advisory Council.

The guidance document provides recommendations for identifying an optimized dosage for radiopharmaceutical therapies for cancer treatment during clinical development.

The company will highlight how its GMP services combine engineering, consulting, equipment qualification, and facility validation to better integrate its services during Farmaforum, which is being held in Madrid from Sept. 17–18, 2025.

Dave Miller, PhD, explains how early formulation planning, novel platforms, and tailored approaches secure long-term protection against generics.

Based on an analysis done by the European Medicines Agency on the feasibility of alternatives, the European Commission maintains use of titanium dioxide in drug products.

Dave Miller, PhD, explains how environmental audits, waste reduction, and supply chain security are reshaping priorities in pharmaceutical manufacturing.

Orphan status was granted based on Phase II data showing that treatment with rilzabrutinib reduced flares and improved markers while demonstrating consistent safety.

Drug development for rare diseases leverages genetic targeting and drives innovation and investment in pharmaceutical technology as well as precision medicine, according to Dan Williams, PhD, CEO, SynaptixBio.

Dave Miller, PhD, discusses how shifting drug manufacturing to domestic CDMOs can improve quality, reduce rework, and enhance long-term efficiency.

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.

Orforglipron showed clinically meaningful results at 72 weeks, after three doses, in a pool of more than 3000 adults.

The investment will expand the company’s manufacturing and packaging capabilities at its Maple Grove, Minn. site, which Bora acquired in 2024 with its acquisition of Upsher-Smith Laboratories.