Chitra Sethi

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).

How did biopharmaceutical professionals fare during a year of hiring freezes, high anxiety, and increased workload? Our survey finds out.

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

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 cut jobs.

Shire has gained European approval for its gaucher disease treatment

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

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.

Genzyme has signed a new supply agreement with Hospira Inc

Celgene to Acquire Abraxis

Vetter held a groundbreaking ceremony for its new facility in Ravensburg.

G. Steven Burrill released his 24th annual report on the state of the biotech industry at the BIO International Convention held in Chicago this month. Biotech 2010 -Life Sciences: Adapting for Success provides insight into biotech' s changing environment and how the industry will need to adapt to it.

The biopharmaceutical company Genzyme Corporation (Cambridge, MA), is expected to be fined $175 million by the US FDA as part of the agency?s enforcement action to ensure that products manufactured at Genzyme?s Allston, MA, plant are made in compliance with GMP regulations.

The biopharmaceutical company Genzyme Corporation (Cambridge, MA), which suffered from a series of manufacturing problems including viral contamination at its Allston Landing plant in June 2009, has announced that it will phase out its fill-finish operations from the plant gradually.

A critical GMP requirement for drug manufacturers is to validate analytical test methods to ensure that they are suitable for their intended uses. There are published guidelines available that the industry can follow for validation but there are none for qualification, which is a key step in the validation process.

AstraZeneca will cut 500 research and development positions at its US headquarters in Fairfax, DE.

German pharmaceutical and chemicals company Merck KGaA will buy US biotech equipment-maker Millipore for $7.2 billion.

Eli Lilly & Company received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMP) in the manufacture of active pharmaceutical ingredients (APIs) at its facility in Carolina, Puerto Rico.

Merck & Co. (Whitehouse Station, NJ) has announced restructuring plans that include reducing its companywide workforce by 15% by the end of 2012.

Novavax will discontinue negotiations for the previously announced collaboration with Madrid-based ROVI Pharmaceuticals.

Watson Pharmaceuticals has acquired Eden Biodesign for $15 million.

London-based pharmaceutical company AstraZeneca plans to slash 8,000 jobs, or 12% of its work force, by 2014 to cut costs.

The results of BioPharm International's fourth annual salary survey, conducted in the fall of 2009, shows that women lag behind their male counterparts.

Genzyme (Cambridge, MA) will outsource fill-and-finish operations for its drugs Cerezyme, Fabrazyme, Myozyme, and Thyrogen to Illinois-based Hospira, Inc.

The year 2009 was marked by recession, industry megamergers, and venture-capital scarcity. How did biopharmaceutical professionals fare?

Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group, is voluntarily recalling about 800,000 doses of H1N1 (swine) flu vaccine meant for children between the ages of 6 months and 35 months because quality assurance tests indicate the vaccine doses lost some potency.

The US Food and Drug Administration has approved Agriflu, a new seasonal flu vaccine manufactured by Novartis Vaccines and Diagnostics (Siena, Italy), for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

The Swiss pharmaceutical company Novartis has opened a new vaccine manufacturing facility in Holly Springs, NC.

In an attempt to save around $60 million annually, the Danish biopharmaceutical company Genmab is planning to sell its manufacturing facility located in Brooklyn Park, MN, and reduce headcount by approximately 300 positions.

In a ribbon-cutting ceremony held on October 30, 2009, Sartorius (Goettingen, Germany) inaugurated its new plant at the Sartorius Group's location in Bangalore, India.