Formulation and Drug Delivery

An Orthogonal Approach to Biosimilarity

April 02, 2015

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

Welcome to the Biosimilar Era

April 02, 2015

FDA approves a biosimilar and loses a commissioner in March.

Multivariate Data Analysis Finds Use In Biopharmaceutical Process Development And Scale-Up

April 02, 2015

Multivariate data analysis (MVDA) is being used to effectively handle complex datasets generated by process analytical technology (PAT) in biopharmaceutical process development and manufacturing.

Merck Joins CAR T-cell Market with $941 Million Intrexon Alliance

March 31, 2015

Merck Serono announces that it will work with Intrexon to develop a cancer therapy using chimeric antigen receptor T-cells.

Rentschler Commissions 2000-L Single-Use Bioreactor

March 30, 2015

Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.

Industry Responds to FDA Labeling Rule

March 30, 2015

Drug makers back alternative to FDA labeling update rule.

FDA Denies Amgen's Certification Petition in Biosimilar Patent Dance

March 30, 2015

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

The White House Responds to Superbug Threats

March 27, 2015

The White House confirmed that it would release a plan to tackle the growing problem of antibiotic-resistant superbugs.

Recipharm and Adroit Science Collaborate to Expand Development Services

March 26, 2015

Adroit Science AB will support Recipharm’s pharmaceutical development with solid-state characterization services.

FDA Expands Usage of Regeneron’s Eylea

March 26, 2015

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.