Drug Development

Articles

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

Mylan and Biocon Get Approvals for Biosimilar Insulin Glargine in Europe and Australia

Fujifilm acquires cell culture media companies Irvine Scientific Sales Company and IS Japan.

Fujifilm Expands Bioprocessing Scope

The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.

FDA Grants Priority Review to AstraZeneca’s Leukemia Biologic

Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics. 

Pfizer Transfers CAR-T Assets to Allogene

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Particle engineering using jet milling or spray drying can be used to obtain appropriate particle characteristics for inhalation drug products.

Optimizing Particle Engineering Methods for Inhalation Drug Products

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

Multiple Views Deliver Complete Characterization of Protein Particles

CMOs/CDMOs that are easy to work with, have demonstrated performance track records, and plan for the future are preferred.

Unlocking the Best Solution for API Sourcing

The companies will co-develop and co-promote a CAR T cell therapy in the United States.

Celgene, bluebird bio Partner on CAR-T Therapy

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

Novartis Gets Positive EMA Opinion on Biosimilar to J&J’s Remicade

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

APIs and Excipients