Chitra Sethi

SAFC Pharma has announced the completion of an addition to its Carlsbad, CA, facility, which specializes in the process development and manufacturing of viral vaccines and viral therapeutics.

Colorado-based InVitria, a division of the biopharmaceutical company Ventria Bioscience, has launched an animal-free recombinant transferrin for use in mammalian cell culture.

Protalix BioTherapeutics, Inc. (Carmiel, Israel) gained orphan drug status from the US FDA for prGCD, a development drug for Gaucher?s disease, on September 9. The orphan drug designation for prGCD was granted by the FDA?s Office of Orphan Products Development and comes less than a month after the drug received fast-track designation from the FDA.

Shire plc (Cambridge, MA) has completed its submission of a new drug application (NDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the US Food and Drug Administration.

Pharmaceutical giant Pfizer, Inc., (New York, NY) has opened a new 64,600-square-foot biotech plant in Strangnas, Sweden.

London-based GlaxoSmithKline?s Hiberix, a haemophilus influenzae Type b (Hib) vaccine, was approved by the US Food and Drug Administration.

The House Energy and Commerce Committee approved a legislative amendment that would give 12-years data exclusivity to innovator biologics. The amendment was introduced by Reps. Anna Eshoo (D-CA) and Jay Inslee (D-DC).

French drug manufacturer Sanofi Aventis will purchase the Indian vaccine company Shantha Biotechnics for $784 million.

In an effort to boost its biologics pipeline, Bristol-Myers Squibb (BMS, New York, NY) will acquire Medarex (Princeton, NJ) for approximately $2.4 billion.

The Senate?s Health, Education, Labor, and Pensions Committee yesterday passed The Affordable Health Choices Act, the committee?s healthcare reform legislation that gives 12 years of data exclusivity to innovator biologics. The committee had adopted the 12-year data protection amendment to the healthcare legislation on Monday.