Formulation and Drug Delivery

FDA Issues CRLs to Celltrion for Two Biosimilars

April 09, 2018

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

Boehringer Ingelheim and OSE in Immuno-Oncology Deal Worth $1.7 Billion

April 06, 2018

Boehringer Ingelheim and OSE Immunotherapeutics have entered a global immuno-oncology partnership to develop a checkpoint inhibitor for treating advanced solid tumors.

Reig Jofre and Leanbio Form Joint Venture to Develop Biosimilars

April 05, 2018

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

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

April 05, 2018

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

Fujifilm Expands Bioprocessing Scope

April 05, 2018

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

FDA Grants Priority Review to AstraZeneca’s Leukemia Biologic

April 03, 2018

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

Pfizer Transfers CAR-T Assets to Allogene

April 03, 2018

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

Optimizing Particle Engineering Methods for Inhalation Drug Products

April 02, 2018

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

Multiple Views Deliver Complete Characterization of Protein Particles

April 02, 2018

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

Unlocking the Best Solution for API Sourcing

April 02, 2018

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