• Janssen Therapeutics, of Titusville, N.J., a unit of Johnson & Johnson, said the FDA approved Intelence (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI), for use in combination with other antiretroviral (ARV) medications in HIV-1 treatment-experienced pediatric patients, ages 6 to younger than 18, who are experiencing virologic failure with HIV-1 strains resistant to NNRTIs and other ARVs. Read More
• Galectin Therapeutics Inc., of Newton, Mass., said the overallotment from its underwritten public offering was exercised in full, resulting in the purchase of an additional 173,916 units at $9 each and generating about $12 million from the offering. Read More
• Morphotek Inc., of Exton, Pa., completed enrollment in a Phase III trial (FAR-131) of farletuzumab for ovarian cancer. The randomized, double-blind trial will compare farletuzumab at two doses in combination with second-line standard of care against standard of care and placebo with a primary endpoint of progression-free survival. Read More
• iBio Inc., of Newark, Del., reported data from preclinical vaccine applications of its lichenase fusion-protein technology suggesting that lichenase-fused antigens prolonged vaccine effectiveness and lowered the required antigen dose in tests conducted with antigens from anthrax, plague and malaria. Read More
MAP Pharmaceuticals Inc. confirmed late Monday what the rumor mills had already deduced: The company received a complete response letter from the FDA for Levadex, its orally inhaled formulation of intravenous migraine drug dihydroergotamine (DHE). Read More
As far as bacteria go, tales of the heroic struggle between man and microbe – complete with warnings of coming plagues – may make for the most riveting stories. Read More
The FDA approved Affymax Inc.'s anemia drug Omontys (peginesatide) for adult dialysis patients with chronic kidney disease. It is the first new erythropoiesis-stimulating agent (ESA) approved since 2001. Read More
