Chitra Sethi

Chitra Sethi, Managing Editor, BioPharm International


Spectrum Pharmaceuticals to Develop Biosimilar Rituximab

California-based biopharmceutical company Spectrum Pharmaceuticals will develop a biosimilar version of Swiss pharmaceutical giant Roche Holding AG's monoclonal antibody drug rituximab. Spectrum aims to achieve this through a partnership with Viropro Inc (Irvine, CA).

ATMI Acquires Artelis to Expand Portfolio of Single-Use Technology Products

ATMI, Inc. has acquired the Belgian biotechnology firm Artelis SA, which offers technologies for cell culture research and manufacturing scale-up.

Gilead Sciences Receives FDA Warning Letter

On September 21, 2010, Gilead Sciences (San Dimas, CA) received a warning letter from the US Food and Drug Administration, citing violations of current good manufacturing practices (cGMP) for its manufacturing and quality processes related to the production of antifungal agent AmBisome at its California facility.

Genzyme and Sanofi Slash Workforces

Genzyme and Sanofi cut jobs.

Shire Gains European Approval for its Gaucher Disease Treatment

Shire has gained European approval for its gaucher disease treatment

EMA and FDA Seek Applicants for Joint GMP Inspections

EMa and FDA are seeking potential candidate companies for a joint GMP inspection pilot program.

ATMI Expands Bloomington, Minnesota Manufacturing Facility

ATMI Inc. has established a North American hub for the production, marketing, and development of its single-use technologies for biopharmaceutical and other life sciences applications by expanding its Bloomington, MN manufacturing facility.

Hospira to Handle Fill-Finish Operations for Genzyme's Multiple Drugs

Genzyme has signed a new supply agreement with Hospira Inc