Archive for October, 2009

Arzerra receives FDA approval

genmab_logoThe FDA has approved Arzerra for the treatment of patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab. Arzerra is a monoclonal antibody that causes the body’s immune response to fight against normal and cancerous B-cells. Arzerra attaches to the small and large loop epitopes on a molecule called CD20, which is found on the surface of B-cells, the type of cell which becomes cancerous in CLL.

FDA approves Talecris Biotherapeutics PROLASTIN-C

TalecrisTalecris Biotherapeutics has received approval from the Food and Drug Administration (FDA) for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of PROLASTIN® produced using advances in manufacturing technology. PROLASTIN-C is indicated for the treatment of alpha1-antitrypsin (AAT) deficiency, a genetic condition in which low levels of this essential protein can result in emphysema. The active protein in PROLASTIN-C increases or “augments” protein levels in AAT-deficient patients at risk for developing emphysema.

Report says greens can also pose health risk

CenterforScienceLeafy greens, tomatoes, even sprouts are among the ten foods that pose the biggest risks of food poisoning, according to a new report from the nonprofit Center for Science in the Public Interest. These 10 foods account for roughly 40% of all food borne outbreaks linked to FDA-regulated food, the report found. Leafy greens top the list, followed by eggs and tuna. While cheese came in at the sixth position, berries, which are loaded with antioxidants, were tenth on the list.

Dyadic International receives FDA approval for cellulase enzyme

DyadicDyadic International Inc has received approval from the FDA for the use of its C1-derived cellulase enzyme. The enzyme is derived from a genetically modified strain of its patented C1 organism and is used in the fermentation of wine, beer and fruit juices. The approval is known as a “GRAS,” which acknowledges that the product is safe to use in its intended conditions of use.