The company’s pharmaceutical educational initiative will now include an extensive collection of assets as well as an extensive library of research, industry insights, and case studies for packaging professionals.

The site in Ridgefield, N.J., will provide Thermo with additional U.S. drug product manufacturing capacity and will allow the company to meet the growing demand from pharma and biotech customers for U.S. drug product manufacturing.

Contrasting outcomes for Roche’s investigational anti-ST2 monoclonal antibody treatment for COPD, mean the company needs to discuss the outcomes with regulatory authorities and evaluate next steps.

The CDMO model is evolving to incorporate more innovative approaches and specialist capacity as a result of the increasingly complex development pipeline. In this article, The Pharma Navigator editors provide a snapshot of some of the news from CDMOs helping innovators with their formulation requirements.

While the final regulatory decision is expected in the first half of 2026, the expanded use of Arexvy, to include younger at-risk adults, could help protect more than 21 million Americans vulnerable to RSV.

Increasingly complex and diverse molecules in the development pipeline and greater demand for patient-centricity are leading to a need for developers to employ advanced formulation approaches and strategies.

The company’s research in a well-established rodent model has shown that EB-003 has potential as an effective treatment for post-traumatic stress disorder, representing an opportunity in an underserved market.

Customers in Germany, France, Benelux, Poland, and the Nordics will be able to purchase the higher bulk density excipients, which are useful for those seeking to reduce tablet size, from Brenntag.

With this latest private transaction, Bain Capital, a private investment firm, joins PCI’s investor base of Kohlberg, Mubadala, and Partners Group, which are focused on supporting the company in its growth plans.

As the complexity of drug molecules evolve and patient expectations grow, industry leaders reveal why the next generation of drug delivery must balance cutting-edge science, flexible manufacturing, and patient-centric design.

With a grant of £1 million from Innovate UK, Cellular Origins, the CGT Catapult, and Resolution Therapeutics will work together to create a fully automated, scalable cell therapy manufacturing platform.

The partnership will see the integration of a real time glucose monitoring platform into a bioreactor range, eliminating the need for manual testing of nutrients and improving data resolution.

The oral dosage market is being shaped by a variety of innovations aimed at improving bioavailability, enhancing patient-centricity, and supporting complex molecules with sophisticated formulation solutions.

A new priority review program, unveiled by the FDA with the potential to dramatically reduce the regulatory review process for drug applications, will require increased agility, responsiveness, and readiness from CDMOs with less room for error.

Cell therapies are distinct from other therapies, meaning that CDMOs shouldn’t take a cookie-cutter approach to these unique projects, notes Nirupama Pike from Catalent in this post-BIO 2025 interview.

Marking a strategic move for the company, the expansion will enable acceleration of pre-clinical development of the circVec circular RNA expression data platform.

Oral solid dosage formulation strategies are being reshaped to align with the evolving regulatory landscape and to enhance patient safety by mitigating potential contamination risks.

With the durvalumab-based perioperative regimen, MIBC patients have a new treatment option that has been proven to provide statistically significant and clinically meaningful improvement in survival rates.

BioVersys and Shionogi are joining forces to progress the development of non-tuberculous mycobacteria clinical candidates with the potential for a selected number of molecules to be licensed for global commercialization.

This regulatory decision, which has been accepted under an accelerated basis, makes sunvozertinib the only approved targeted oral treatment for NSCLC with EGFR exon20ins.