Drug Development

Articles

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.

FDA Describes Its Approach to Genome-Edited Products

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

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.

Switching Studies Crucial to Demonstrate Biosimilar Interchangeability

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.

FDA Guidance on Biosimilar Naming Receives Mixed Response from Industry

A capsule technology for enteric protection and delayed release without a functional coating

The membrane-based Protein A purification tool was unveiled at the 2017 PepTalk Conference in San Diego, California.

Gore Releases New Fluoropolymer-Based mAb Purification Technology

Language surrounding regenerative medicine and the REGROW Act appeared back into the 21st Century Cures Act right before it passed. What will this mean for the controversial testing and marketing of stem-cell therapies?

How Tightly Should Stem-Cell Therapies Be Regulated by FDA?

The companies will combine expertise on T-cell therapies with two or more binding domains to create novel oncology medications.

Amgen Links with Immatics to Continue Work on Bispecific T-Cell Therapies

The partnership will focus on providing practical information to clients on the development of biologics and vaccines.

CSSi LifeSciences and BioMARC Partner to Accelerate Biologics Manufacture

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.

Drug Quality Key to Innovation and Access

Ashleigh Wake is director of Biological Services, Intertek.

Analytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.

Formulation and Drug Delivery