23:51 , Aug 8, 2018 |  BC Innovations  |  Distillery Therapeutics

Cardiovascular

INDICATION: Myocardial infarction (MI) Cell culture and mouse studies suggest Tregs or factors secreted by Tregs could help treat MI. In primary rat cardiomyocytes, supernatant derived from the media of primary rat Treg cultures increased...
23:56 , Jul 26, 2018 |  BC Extra  |  Company News

Reese succeeding Harper as Amgen EVP of R&D

Amgen Inc. (NASDAQ:AMGN) said EVP of R&D Sean Harper will retire and be succeeded by SVP of Translational Sciences and Oncology David Reese. The company also reported 2Q18 earnings on Thursday after market hours that...
21:30 , Jul 24, 2018 |  BC Innovations  |  Translation in Brief

Interaction analysis

In a collaboration with Merck & Co. Inc. (NYSE:MRK) and SomaLogic Inc., University of Cambridge researchers have identified associations and causal relationships between thousands of genetic variants, plasma proteins and disease states, which could reveal...
20:50 , Apr 6, 2018 |  BC Week In Review  |  Clinical News

EC approves Xgeva for MM patients

Amgen Inc. (NASDAQ:AMGN) said the European Commission approved a label expansion for Xgeva denosumab to include the prevention of skeletal-related events in patients with multiple myeloma (MM). FDA approved Xgeva in the same indication in...
13:08 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

Amgen's denosumab misses in Phase III as adjuvant treatment for breast cancer

Amgen Inc. (NASDAQ:AMGN) and partner Daiichi Sankyo Co. Ltd. (Tokyo:4568) reported top-line data from the Phase III D-CARE trial in 4,509 breast cancer patients showing that subcutaneous denosumab (Prolia, Pralia, Ranmark, Xgeva, AMG 162) as...
16:21 , Jan 12, 2018 |  BC Week In Review  |  Clinical News

FDA approves sBLA for Amgen's Xgeva for MM patients

Amgen Inc. (NASDAQ:AMGN) said FDA approved an sBLA for Xgeva denosumab (Prolia, Pralia, Ranmark, AMG 162) to prevent skeletal-related events in adults with multiple myeloma (MM) ahead of its Feb. 3 PDUFA date. Amgen already...
12:26 , Jun 22, 2017 |  BC Week In Review  |  Clinical News

FDA accepts sBLA for Amgen's Xgeva to prevent fractures in MM patients

Amgen Inc. (NASDAQ:AMGN) said FDA accepted an sBLA for Xgeva denosumab (Prolia, Pralia, Ranmark, AMG 162) to include prevention of fractures and other skeletal-related events (SREs) in patients with bone metastases from multiple myeloma (MM)....
19:48 , Mar 10, 2017 |  BC Extra  |  Company News

FDA extends review of Radius' osteoporosis candidate

Radius Health Inc. (NASDAQ:RDUS) slipped $2.26 to $40.85 on Friday after it said FDA delayed by three months the PDUFA date for abaloparatide-SC (BA058-SC), which it is reviewing to treat postmenopausal osteoporosis. The new PDUFA...
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...