
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.
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.
Dealmaking
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.
The collaboration will leverage Bend’s expertise in controlled release formulation, manufacturing process, and analytical method development, and Starton’s deep understanding of continuous delivery of lenalidomide.
The companies will combine a drug discovery platform and a novel framework to reduce the cost and time it takes to develop complex therapies.
The proposed acquisition will expand Sanofi’s immunological portfolio with a precision medicine already approved for the treatment of ASM and ISM, a next-gen highly selective kinase inhibitor, and an investigational oral drug.
Future Biopharma
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.
The biologics sector is rapidly evolving thanks to scientific innovation and investment. In this article, insights and perspectives from a selection of senior leaders shaping the future of biologics are reviewed.
R&D
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.
The Michael J. Fox Foundation for Parkinson’s Research and the Luxembourg National Research Fund have provided funding for two separate projects assessing Accure Therapeutics’ ACT-02 for the treatment of Parkinson’s disease.
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 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.
Despite current hurdles facing biopharma and biotech companies, the recent BIO International Convention event saw innovation take center stage and provided a sentiment of optimism for the future, so long as industry does not rest on its laurels.
Drug development companies are struggling to gain financial support because management capabilities are lacking. In this BIO 2025 interview, Ali Pashazadeh from Treehill Partners discusses the investment landscape in more detail.
Regulatory
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.
This regulatory decision, which has been accepted under an accelerated basis, makes sunvozertinib the only approved targeted oral treatment for NSCLC with EGFR exon20ins.
The once-monthly injection, which is the first FDA-approved HAE treatment, was proven to significantly reduce HAE attacks in a Phase III trial and strengthens CSL’s presence in the competitive rare disease market.
Upcoming Events
The CRS 2025 Annual Meeting & Exposition will take place in the vibrant city of Philadelphia, PA, USA, from July 14-18, 2025. This year, under the exciting theme "Next-Generation Delivery Innovations," they will explore groundbreaking advancements and transformative ideas in controlled release science and technology.
AAPS brings scientists working in pharmaceutical analysis and bioanalysis together in the Summer Scientific Forum. Dive deep into the latest research in these areas, then cross-connect with other scientists in shared high-level sessions focused on regulatory issues that impact both disciplines.
Join the 4th Process Development for Cell Therapies Summit to hear from 24+ industry leaders from biopharma and service providers as they share best practices for driving process robustness, scalability, speed, and affordability. Gain insights into how to develop consistent, scalable, and cost-effective solutions for both autologous and allogeneic cell therapies.