Drug Development

Beata Vladovicova, PhD, is R&D manager at Saneca Pharma, www.saneca.com.

Articles

More agile techniques are improving the development of multiparticulate drug-delivery systems.

Advancements in Extrusion-Spheronization

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

Alexandre Juillerat, PhD, innovation senior scientist at Cellectis, discusses novel construct UCART123, an investigational agent that is on deck to be the first gene-edited T-cell product in the United States.

Honing in on the Tumor Microenvironment

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

EMA Recommends Approval of Two Biosimilars

ADMA will acquire BPC’s plasma-based fractionation and purification plant in Boca Raton, FL and plans to resolve issues at the facility noted in an FDA warning letter.

ADMA Biologics to Acquire Plasma-Based Biologics Facility from Biotest

Researchers from Cellectis investigate how external signals in the tumor microenvironment could control the cell-surface expression and specificity of engineered CARs.

Cellectis Describes Novel CAR-T Design in New Paper

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

Merck Settles Litigation with Bristol-Myers Squibb on Use of Antibody Targeting PD-1

Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.

Reproducibility Project only Partially Able to Validate Findings of Prominent Cancer Studies

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

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.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

Formulation and Drug Delivery