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Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.

Nicholas Giovannone of Regeneron explained the strategies behind overcoming re-administration challenges in a recap of his presentation at ASGCT 2025.

BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, enters late-stage trials for lung and breast cancer with joint development by BioNTech and BMS.

Science is propelling advances and operational shifts in the bio/pharmaceutical industry.

In this recap of a poster presentation, Austin Daniels of Yokogawa Fluid Imaging Technologies explains how flow imaging microscopy can detect the amount and types of both subvisible and visible particles in samples not often detected by traditional methods.

Jerry Chapman of Redica Systems spoke with BioPharm International® about how artificial intelligence can assist in analyzing a clinical site to determine risk factors and spotlight potential future risks.

In discussions at INTERPHEX 2025, company representatives seized upon several common themes, most notably safety, sustainability, and the increasing utility of automation.

Biocon Biologics’ Yesintek demonstrated comparable safety and efficacy to the originator project, according to clinical data from a trial program.

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Funding will support the company’s efforts to refine its proprietary glycan-engineering platform, expand its scientific and operational team, and advance preclinical studies of its engineered biologics.

BioPharm International® spoke with Oury Chetboun, CEO of Seekyo Therapeutics, to get his perspective on what impact new modalities and technology innovations are having on biopharmaceutical development.

Sanofi is acquiring Vigil Neuroscience, a biotech firm focused on novel neurodegenerative disease therapies, to boost its early-stage neurology pipeline.

The company’s presence at ASGCT included not only a booth on the show floor, but also one oral and nine poster presentations.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit.

Mirai Bio and Thermo Fisher partner to integrate AI-driven design with CGMP manufacturing, aiming to streamline development of genetic medicines.

A letter of intent has been signed by the two companies for supply of artificial platelet raw material.

A late-breaking poster presented at ASGCT 2025 described the enhanced central nervous system transduction and safety of the vector.

A pediatric patient with a rare genetic disorder safely received a personalized CRISPR therapy, marking the first known case of a personalized CRISPR-based medicine administered to a single patient.

Tevard's tRNA therapy appears to restore full-length dystrophin and motor function in a Duchenne muscular dystrophy model, showing promise for nonsense mutation treatments.

The poster presentations contain data highlighting the company’s role to date in developing non-replicating HSV-1 technology for use in neurology.

The company’s technology was used to create CAR-T cells that demonstrated the expression of complex CARs in a single DNA donor.

According to the White House, the order builds on actions taken in the president’s first term to reduce price disparities domestically.

The proposed $700 million, 700,000-square-foot space will support the companies’ future joint portfolio of next-generation obesity medicines.

BioPharm International® spoke with Ryan Larson, PhD, SVP, Head of Research at Umoja BioPharma about how emerging modalities in cancer treatments, including cell therapies, are evolving.

The company has had abstracts accepted for three oral presentations and five posters.

While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as transactional relationships, but true partners with a common goal of getting drugs to patients faster.

Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

As more originator biologics lose patent exclusivity in the next decade, a healthy biosimilars pipeline is necessary but requires market support.

Although automation is increasingly adopted in biomanufacturing, challenges remain in implementing it at the cell harvesting step.