Despite a few FDA qualms, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) embraced a fixed combination diabetes drug that couples a titratable basal insulin product with a glucagon-like peptide-1 (GLP-1) receptor agonist that has only a few recommended effective doses. Read More
With a pivotal phase II/III trial to start "in the next several weeks," Oxigene Inc. CEO William Schwieterman told BioWorld Today that the just-published results on CA4P (fosbretabulin) paired with approved cancer therapy Avastin (bevacizumab, Roche AG) in recurrent ovarian cancer "are potentially huge for the field" of vascular-targeted therapy in solid tumors. "While [CA4P] is old, we have a new plan and a new story," he said. Read More
Preliminary data from a pivotal phase III test of experimental HIV drug ibalizumab, developed by Taimed Biologics Inc. and slated for marketing by Theratechnologies Inc., helped 82.5 percent of patients receiving it meet the study's primary endpoint of a decrease of ≥ 0.5 log10 in viral load following a seven-day treatment period. Theratechnologies shares (TSX:TH) climbed 8.5 percent to close at C$2.55 (US$1.94) on Tuesday. Read More
LONDON – There are two repurposings for the price of one in the launch today of Iceni Pharmaceuticals Ltd., with the former DNA vaccines company transmuting into a cancer specialist and bringing cilengitide, an integrin inhibitor that previously failed in a phase III trial in glioma, back into the clinic as a treatment for multiple myeloma. Read More
SHANGHAI – Dozens of Chinese biopharmas have entered the CAR T race, but Shanghai-based Innovative Cellular Therapeutics Co. Ltd., (ICT), also known as Sidansai in Chinese, is angling to be the front-runner. Read More
TOKYO – Fintech Global Capital LLC (FGC), a Japanese venture fund, is looking to raise about $50 million this year, mainly from institutional investors, to be spent on biotech companies in 2017. Read More
Relief Therapeutics SA, of Geneva, received an initial tranche of funding from Global Emerging Markets as part of a planned €2.5 million (US$2.8 million) series A round to support planning for clinical development activities for lead drug atexakin alfa. Read More
Alimera Sciences Ltd., of Atlanta, said real-world data show that the majority of diabetic macular edema patients who received Iluvien (fluocinolone acetonide 190 mcg intravitreal implant in applicator) in routine clinical practice gained or maintained vision at 12 months. Read More
Boehringer Ingelheim GmbH, of Ingelheim, Germany, presented results from a phase II study in Crohn's disease at Digestive Disease Week in San Diego, showing that risankizumab (formerly BI 655066), a compound recently licensed by Abbvie Inc., of North Chicago, was found to be more effective than placebo in patients with moderately to severely active Crohn's. Read More