Formulation and Drug Delivery

EMA Revises Guideline on Clinical Development Requirements for Fixed Combination Products

May 20, 2015

The new guideline replaces the previous version-CHMP/EWP/240/95 Revision 1.

Alexion to Build Biologics Facility in Ireland

May 19, 2015

Alexion will construct a biologics facility in Ireland that is its first outside the US.

Controlled Nucleation for a Monoclonal Antibody Formulation—A Case Study

May 15, 2015

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

Pall to be Acquired by Danaher

May 13, 2015

Pall has agreed to be acquired by Danaher for $127.20 per share.

Baxter BioScience Expands Oncology Business

May 13, 2015

With acquisition of Oncaspar portfolio for leukemia from Sigma-Tau Finanziaria, Baxter BioScience adds an oncology infrastructure and biologic.

FDA Releases Q&A on Biosimilars

May 12, 2015

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

Vaccine Patch Could Eliminate Traditional Protocol for Vaccine Delivery

May 11, 2015

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

Court Blocks First FDA-Approved Biosimilar, for the Time Being

May 07, 2015

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

Biosimilar Giants Launch Biosimilars Forum

May 06, 2015

Eleven of the leading US biosimilar developers have collaborated to form the Biosimilars Forum, a nonprofit organization formed to expand patient access to biosimilars.

Transdermal Drug Delivery Gains Traction

May 04, 2015

Advances in transdermal drug delivery, particularly with microneedles, are enabling a wider range of drugs to be delivered through the skin.