Drug Development

Articles

The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.

Biosimilars Forum Launches Education Initiative

Agnes Shanley is senior editor of Pharmaceutical Technology.

For successful partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front.

Keeping It Simple: Collaborating for Success in Drug Delivery

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

The reporter bioassay, used to evaluate ADCC activity of therapeutic antibodies, complements the classical ADCC assay.

Assessing Antibody-Dependent Cell-Mediated Cytotoxicity

Hermes Pharma has commercially implemented hot-melt coating (HMC) technology at its production facility.

Hermes Pharma Adds Hot Melt Coating Capability

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

FDA Seeking Feedback on Generic Drug Recommendations

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

NICE Announces Plans to Back Remicade Biosimilars

The collaboration will focus on development of novel molecules using SMARTag technology to couple different therapeutic modalities.

Catalent Biologics and Roche Announce Research Collaboration

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

mAbs to Watch in 2016

Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development.

Phase-Appropriate Formulation and Process Design

Liquid formulations in hard-shell capsules or softgels are becoming a popular option for HPAPIs because of advantages such as improved safety and lower risk of potential exposure and product cross contamination.

Formulation and Drug Delivery