Already trailing approvals of obesity drugs Belviq (lorcaserin) and Qsymia (phentermine/topiramate) by two years, Orexigen Therapeutics Inc.'s Contrave (naltrexone/bupropion) is facing another delay at the hands of the FDA, which pushed back the PDUFA date by three months to Sept. 11. Read More
In two separate studies, researchers have identified new links between immunity and metabolism, showing that exercise activates immune cells that can turn energy-storing white fat into one type of energy-burning brown fat. Read More
Ruiyi Inc. and the Ihuman Institute forged a research collaboration allowing the upstart educational institution, housed at China's Shanghaitech University, to apply the company's intermembranous conformation antigen presenting system, or iCAPS, technology for the creation of monoclonal antibodies (MAb) that specifically bind to G protein-coupled receptors (GPCR). Read More
The specter of more drugs that cost upward of $84,000 hovered over a House subcommittee hearing Wednesday on whether current incentives are adequate to spur development of therapies for unmet medical needs such as Alzheimer's disease. Read More
SHANGHAI – While Wuxi Apptec may be best known for its biologic manufacturing capabilities, it could be overlooked that the firm has ratcheted up its capabilities in clinical drug development as well. Read More
Alzprotect, of Lille, France, said it completed a €2 million (US$2.7 million) series A financing round and has been matched by an additional €1 million support from Bpifrance in the form of subsidies and refundable advance payments. Read More
Foamix Inc., of Rehovot, Israel, said it established a U.S. subsidiary, Foamix Pharmaceuticals Inc., located in Bridgewater, N.J., to conduct clinical development operations, including planned trials of minocycline foam, that can be used for the treatment of acne, skin infections and rosacea, and to manage regulatory affairs and to build commercial infrastructure. Read More
Celator Pharmaceuticals Inc., of Ewing, N.J., said the independent data and safety monitoring board (DSMB) for their phase III study of CPX-351 (cytarabine:daunorubicin) liposome injection vs. the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy in older patients with high-risk (secondary) acute myeloid leukemia (AML) has completed a planned safety review and recommended that the study should continue without any modifications. Read More
Abbvie Inc., of North Chicago, disclosed results from its multi-country ALIGN study showing that, across six chronic immune-mediated inflammatory diseases, treatment compliance generally was higher among patients on TNF inhibitors compared to those treated with conventional therapy. Read More
Eli Lilly and Co., of Indianapolis, said the phase III REACH trial of Cyramza (ramucirumab) in patients with hepatocellular carcinoma did not meet its primary endpoint; overall survival favored the drug arm but was not statistically significant. Read More
