23:23 , Jan 11, 2019 |  BioCentury  |  Politics, Policy & Law

Supreme Court may reset FDA-State power balance

Following oral arguments in Merck v. Albrecht on Jan. 7, the Supreme Court is pondering a decision that could reset the balance of power over drug label warnings between FDA and state courts. The outcome...
22:04 , Jan 8, 2019 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Lung cancer Mouse studies suggest inhibiting tumor-associated macrophages (TAMs) with liposomal clodronate could help treat lung cancer. In a mouse model of Lewis lung carcinoma, a liposomal preparation of the bisphosphonate clodronate, which induces...
18:52 , May 30, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Breast cancer Cell culture and mouse studies suggest inhibiting UGT8 could help treat basal-like breast cancer. In four human basal-like breast cancer cell lines, shRNA targeting UGT8 decreased cancer cell colony formation compared with...
22:41 , Apr 24, 2018 |  BC Innovations  |  Distillery Techniques

Disease models

TECHNOLOGY: Animal models Mice with bone-specific overexpression of VEGF-C could be used to screen therapies to treat Gorham-Stout disease. Generation of the model involves crossing a mouse line, in which expression of a tetracycline transactivator...
19:38 , Mar 10, 2017 |  BC Week In Review  |  Clinical News

Xgeva: Additional Ph III 20090482 data

Additional data from the double-blind, international Phase III 20090482 trial in 1,718 patients with newly diagnosed MM showed that 120 mg subcutaneous Xgeva every 4 weeks led to a median time to first on-study SRE,...
21:43 , Feb 1, 2017 |  BC Week In Review  |  Clinical News

Xgeva regulatory update

Amgen withdrew an MAA from EMA for Xgeva denosumab seeking to expand the label to include treatment of hypercalcemia of malignancy refractory to IV bisphosphonate therapy. The company said it withdrew the MAA because EMA’s...
07:00 , May 2, 2016 |  BC Week In Review  |  Company News

Chugai, Taisho Pharmaceutical Holdings, Roche sales and marketing update

Chugai and Taisho launched a monthly oral formulation of Boniva ibandronate in Japan to treat osteoporosis. The National Health Insurance (NHI) price of a 100 mg tablet, the recommended monthly dose, is Y2,790 ($25.11). Chugai...
07:00 , Apr 18, 2016 |  BC Week In Review  |  Clinical News

Romosozumab: Additional Phase III data

Additional data from the open-label, international Phase III STRUCTURE trial in 436 postmenopausal women with osteoporosis at high risk for fracture who were previously treated with bisphosphonate therapy showed that once-monthly 210 mg subcutaneous romosozumab...
08:00 , Mar 7, 2016 |  BioCentury  |  Product Development

Getting hip in osteoporosis

Investors were quick to conclude that Amgen Inc. and UCB Group's romosozumab may be at a disadvantage in the osteoporosis market after the partners reported a miss on non-vertebral fracture rates, and an apparently lower...
08:00 , Feb 1, 2016 |  BC Week In Review  |  Clinical News

Boniva ibandronate regulatory update

Chugai and Taisho said Japan approved a monthly oral formulation of Boniva ibandronate to treat osteoporosis. Japan approved a monthly IV formulation of Boniva in 2013. Chugai partnered with Taisho in 2006 to co-develop and...