
Navigating key news stories in pharma
Featured Stories
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.
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.
Dealmaking
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.
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.
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.
Future Biopharma
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.
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.
The new system has been designed to deliver vaccines and other drug products intradermally, which offers advantages over other forms of injectable administration.
R&D
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.
Business Finland is providing Nanoform with a EUR 5 million R&D loan to be used to accelerate the clinical development of the nanoformulated version of apalutamide through to the pivotal bioequivalence study.
The latest studies on the mechanism of action for LIB-01 have demonstrated that the drug targets the underlying nerves and vascular structures that are involved in penile erections.
Circio presented the enhanced in vivo data for its circVec platform in viral and non-viral vectors at ASGCT 2025.
Expansion
Marking a strategic move for the company, the expansion will enable acceleration of pre-clinical development of the circVec circular RNA expression data platform.
An official groundbreaking ceremony marked the start of construction on the service provider’s new site in Des Plaines, Ill., which will house a clinical production facility for aseptic manufacturing, new process areas for material preparation and compounding, in addition to other buildings.
To meet growing demand for advanced, domestic biomanufacturing capabilities, Enzene Biosciences is scaling up its soon-to-launch New Jersey facility to 80,000 square feet and integrating its proprietary continuous manufacturing platform.
Located within Bend’s Oregon facility, the four new process development and manufacturing suites will support spray drying and unit operations, helping the company to meet the growing needs of clients in these areas.
Strategy
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.
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 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.
Regulatory
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.
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.
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.
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