Formulation and Drug Delivery

Pfenex Announces Partnership with Hospira to Develop Lucentis Biosimilar

February 11, 2015

Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.

Amgen Announces Humira Biosimilar Clinical Studies Success

February 06, 2015

Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.

First Inhalable Insulin Comes to the US

February 04, 2015

Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.

Mylan Partners with Theravance to Develop an Investigational Treatment for COPD

February 03, 2015

Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.

Obama Seeks Drug Pricing Authority, Shortened Data Exclusivity Period for Biologics

February 02, 2015

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

Ligand-Binding Assays and the Determination of Biosimilarity

February 02, 2015

Ligand-binding assays are fundamental to characterizing biosimilars.

Labeling of Biosimilars

February 02, 2015

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Gauging the CMO Biosimilar Opportunity

February 02, 2015

Market forces may limit the success of CMOs.

Particle Engineering for Bioavailability Enhancement

February 02, 2015

Enhancing Dissolution of Poorly Soluble Drugs through Jet-Milling

February 02, 2015

The authors discuss a novel particle engineering technology based on mechano-chemical activation.