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.

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.

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.

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.

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.

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.

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.

The companies will combine a drug discovery platform and a novel framework to reduce the cost and time it takes to develop complex therapies.

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.

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.

Elin Trampe from Dicot Pharma emphasizes the need for innovation in the field of potency drugs, which has been dominated by PDE5 inhibitors, and provides details of an approach that is offering new potential.

The development and manufacture of personalized therapies are challenging for a variety of reasons; however, novel tools that are fit-for-purpose are becoming available, notes Luc Henry from Limula.

For David Westberg from Nanexa, long-acting injectables will continue to see growth in the field of mental health conditions and will also experience dramatic growth in other indication areas, such as Type 2 diabetes and obesity.

Multi-omics is allowing oversight into the relationships between the different layers of cells, allowing for the creation of new types of drugs and treatment strategies, explains Juozas Gordevičius from VUGENE.

Ahead of BIO 2025, Monika Paulė from Caszyme reveals details about a new CRISPR family, Cas12l, which is smaller than Cas9, meaning it could be a good alternative option for companies with certain limitations.

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.