
Navigating key news stories in pharma
Featured Stories
The complexities of next-generation therapies are pushing the boundaries of development and manufacture, leading to an increased need for advanced technologies and novel approaches to processes.
In this interview, Sarah Griffin from Informa Markets provides a review of CPHI Americas 2025 and teases some potential exciting innovations being planned for the 2026 edition of the conference.
Epigenetic modulation has been important in the development of oncology therapies, but its use in cardiovascular diseases is just beginning. In this pre-BIO interview, Sten Sörensen from Cereno Scientific provides some insights into developments in this field.
Prior to BIO 2025, Russell Miller from Enzene Biosciences highlights how a fully connected continuous manufacturing platform is enhancing biologics production and, hence, improving patient access.
Dealmaking
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.
Porton Advanced has announced separate partnerships with TongEYE and Hualong Biological, as it moves into regenerative therapies for vision loss and innovative immunotherapies for solid tumors.
The court supervised purchase, which is still subject to relevant conditions, will see Regeneron acquire the assets of 23andMe, except for its Lemonaid Health business.
The acquisition of efimosfermin alfa, a Phase III-ready FGF21 analog targeting steatotic liver diseases, will expand GSK’s hepatology pipeline and establish a best-in-class therapy for MASH and ALD.
Future Biopharma
Epigenetic modulation has been important in the development of oncology therapies, but its use in cardiovascular diseases is just beginning. In this pre-BIO interview, Sten Sörensen from Cereno Scientific provides some insights into developments in this field.
Prior to BIO 2025, Russell Miller from Enzene Biosciences highlights how a fully connected continuous manufacturing platform is enhancing biologics production and, hence, improving patient access.
Solid tumors are difficult to treat as a result of numerous factors, in this interview, Oury Chetboun from Seekyo Therapeutics, details how targeting functional proteins in the tumor microenvironment can help.
Treating metastases with an external laser beam can prove challenging; however, radiotherapeutics are providing more targeted treatment options, radiating the tumor cells from within, specifies David Bejker from Affibody.
R&D
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.
Through analysis of historical vaccination program data, researchers have demonstrated a persistent link between the live-attenuated zoster vaccination and a lower incidence of dementia.
Expansion
The company has added the further sterile fill/finish capacity to the site in response to continued growth in demand for its drug product services.
The new facility adds to the company’s existing infrastructure and is set to provide comprehensive technical support for bioprocessing to biopharmaceutical companies and contract manufacturers.
This latest investment into expanding its manufacturing capabilities reinforces the company’s commitment to the U.S. and enhances its global biomanufacturing network.
The acquisition will provide PCI with a large-scale manufacturing hub on the West Coast of the U.S., complementing its existing global facilities.
Strategy
In this interview, Sarah Griffin from Informa Markets provides a review of CPHI Americas 2025 and teases some potential exciting innovations being planned for the 2026 edition of the conference.
While the spread of misinformation about vaccines is contributing to greater vaccine hesitancy, global rates of measles outbreaks are rising at alarming rates, leading to warnings being issued to international travelers.
As CPHI Americas wraps up for another year, we look back at some of the highlights from the conference and exhibition hall, and provide a sneak peek of a great opportunity at CPHI Frankfurt.
The change to the company’s leadership has been expedited as a result of the difficult market conditions and drop in share price that the company has experienced since mid-2024.
Regulatory
As a result of the capability to be used across multiple therapeutic programs, the U.S. regulatory body has granted Sarepta’s AAVrh74 platform with platform technology designation.
This approval, which was based on the results of a Phase III trial demonstrating a higher relative efficiency of the new vaccine compared with the old version, marks the third for the company from the FDA.
The recombinant protein-based, non mRNA vaccine has been granted full marketing approval to prevent COVID-19 in adults aged 65 years and older and patients aged 12–64 years who are at risk of severe infection due to underlying conditions.
The oral combination therapy has been shown to provide a significant overall response rate in LGSOC patients with disease progression despite prior systemic treatment.
Upcoming Events
The 54th International Symposium on High Performance Liquid Phase Separations and Related Techniques (HPLC 2025) will be held from Sunday through Thursday, June 15-19, 2025, in Bruges, Belgium.
The BIO International Convention is the largest and most comprehensive event for biotechnology, representing the full ecosystem of biotech with 20,000 industry leaders from across the globe.
Returning for its 10th anniversary, the Microbiome Movement Summit remains the premier global gathering for microbiome drug developers, uniting experts across discovery, preclinical, translational, regulatory, and commercial sectors to drive innovation in the microbiome space.
The MedTech landscape is evolving rapidly, with FDA’s shifting expectations, AI-driven regulations, and global compliance challenges putting pressure on companies to innovate while maintaining security and compliance.