News

In Episode 29, John Androsavich, Benjamin Fryer and John Wilkerson go behind the top headlines from 2025.

The new GSK–Oxford BioTherapeutics partnership capitalizes on proteomics-driven oncology target discovery for advancing antibody therapeutics development.

FDA’s approval of the first Wiskott-Aldrich gene therapy signals a shift in manufacturing and regulatory standards for rare-disease CGTs.

FDA’s clearance of a chemically enhanced stem cell therapy for severe aplastic anemia drives forward cell therapy development and manufacturing innovation.

The articles in this issue capture a sector balancing innovation with practicality as it prepares for the next generation of medicines.

Priority review, RMAT, and breakthrough status were key regulatory actions intensely accelerating advanced next-gen therapy development in 2025.

Manufacturing biologics is a complex task. Mitigating risk early in the design of manufacturing facilities and the qualification of equipment minimizes future complications.

FDA’s new-indication approval for lisocabtagene maraleucel in marginal zone lymphoma boosts engineered T-cell treatment for relapsed lymphoma.

siRNA-based cell reprogramming shows potential to improve metabolic health with durable effects, signaling a notable development for future therapeutic strategies.

Engineered exosomes could reshape therapeutic development by redefining delivery, manufacturing models, and regulatory standards.

Flexible manufacturing processes and facilities support the pipeline of allogeneic cell therapies.

FDA outlines reduced primate testing for monoclonal antibodies, signaling a shift toward modern evaluation tools that may influence drug development practices.

The new collaboration will aim to streamline formulation-to-manufacturing workflows and de-risk development.

FDA’s internal findings raise new concerns over pediatric vaccine safety and signal potential regulatory shifts affecting future COVID-19 vaccine development.

How is the biopharma industry solving manufacturing and scale-up bottlenecks for cell and gene therapies? Read on to find out.

The discussion in this Drug Digest video focuses on optimizing biopharmaceutical manufacturing and supply chain efficiency through the mastering of AI capabilities, data integration, and critical validation challenges.

ADC oncology platforms, FDA CNPV rapid review, and significant investment into US biologics manufacturing capacity led this week’s news.

The transformative impact of complex biopharmaceuticals hinges on integrating advanced delivery systems, often accelerated by AI modeling, with robust manufacturing practices and regulatory alignment to ensure stability, safety, and effective patient access.

David Dodd, GeoVax Labs, opines on why vaccine platform diversity is critical in the United States.

Samsung Life Science Fund’s investment in Phrontline Biopharma highlights growing industry momentum behind dual-payload ADCs.

AstraZeneca’s $2 billion investment in its Maryland facilities will expand domestic biologics and rare disease manufacturing and strengthen US drug supply chains.

Five bio/pharma sector leaders dissect FDA’s CNPV pilot program.

Progress in vaccine development is closely tied to advancements in biopharmaceutical technologies, regulatory landscapes, and quality assurance methodologies.

News in the week shows biopharma development being redefined by programmable biology and accelerated FDA review, stressing quality compliance and market efficiency.

Regulators and manufacturers face new uncertainty as shifting CDC vaccine language raises concerns for evidence-based oversight and biopharma compliance.

Five leaders from across the bio/pharma sector explore the opportunities and challenges posed by FDA’s CNPV pilot program.

Microfluidic rapid-testing advances enhance real-time QC, strengthen compliance, and speed contamination detection across modern biomanufacturing.