Drug Development

Articles

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).

Amgen, Allergan Score Positive EMA Opinion on Biosimilar to Roche’s Herceptin

Major countries will be ranked based on the potential for biopharma market growth, innovation, and competitiveness. 

bioLIVE to Launch Global Biopharma Country Ranking

Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.

Hitachi to Manufacture Regenerative Medicines

The agreement gives IncoCell Tianjin, a wholly-owned subsidiary of China-based Boyalife Group, access to Cesca’s celluar processing contract development and manufacturing services.

Cesca Licenses CAR-T Cellular Processing Services to China’s Boyalife Group

The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.

Helix BioPharma Partners with ProMab on CAR-T Therapies

The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.

Wuxi Biologics to Install Large-Scale Single-Use Bioreactor

Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for
perfusion culture. 

Ambr 250 High Throughput Bioreactor System Speeds Up Intensified Cell Culture Process Development

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

APIs and Excipients