The European Medicines Agency's Committee for Medicinal Products for Human use issued opinions for eight drugs of interest to the biopharma sector, including thumbs up for multiple sclerosis (MS) drugs from Biogen Idec Inc. and Genzyme Corp. Read More
Although Cerulean Pharma Inc.'s farthest-along trial with nanoparticle-based, camptothecin-loaded CRLX101 missed its endpoint in a Phase IIb trial against advanced non-small-cell lung cancer (NSCLC), a handful of other studies are ongoing and all have "a very strong biological rationale underpinning" them, said Oliver Fetzer, president and CEO of the Cambridge, Mass.-based firm. Read More
Autoimmune disease, Richard Siegel of the National Institute of Arthritis and Musculoskeletal and Skin Diseases told his audience at a recent talk at the National Institutes of Health, is "one of the final frontiers in medicine." Read More
With additional data in the offing for its Leber's Hereditary Optic Neuropathy (LHON) drug Raxone (idebenone), Santhera Pharmaceuticals AG has withdrawn its marketing authorization application (MAA) from the European Medicines Agency's (EMA) re-examination process and will instead submit a new file with an expanded patient database. Read More
• VG Life Sciences Inc., of San Marino, Calif., said it signed a two-year commitment to provide funding toward the operational needs of the firm from current investor MedBridge LLC. Read More
• pSivida Corp., of Watertown, Mass., said licensee Alimera Sciences Inc., of Atlanta, disclosed plans to resubmit a new drug application for Iluvien (fluocinolone acetonide intravitreal implant) in diabetic macular edema (DME) by the end of March. Read More
• Benitec Biopharma Ltd., of Sydney, Australia, selected the Duke Clinical Research Unit in Durham, N.C., as a site for its upcoming Phase I/II first-in-human trial of TT-034 in hepatitis C virus (HCV). Read More
• Simcere Pharmaceutical Group, of Nanjing, China, said the Chinese State Food and Drug Administration issued its approval for GMP certification of the influenza vaccine production facility at subsidiary Jiangsu Simcere Vaxtec Bio-Pharmaceutical Co. Ltd. Read More
• Oculus Innovative Sciences Inc., of Petaluma, Calif., was issued a U.S. patent for its Microcyn Technology to treat skin ulcers in these methods: washing, irrigation, soaking or with a wound dressing that is saturated in the Microcyn Technology. Read More
Scientists at Duke University and Johns Hopkins University have reported new insights into the relationship between telomeres and tumor cells. Read More
