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

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.

The new system has been designed to deliver vaccines and other drug products intradermally, which offers advantages over other forms of injectable administration.

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.

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.