Industry News

- Read more about Zymeworks and Daiichi Sankyo Announce Immuno-Oncology Cross-Licensing Agreement and Bi-Specific Antibody Collaboration
Zymeworks Inc., and Daiichi Sankyo Company, Limited announced that they have entered into a cross-licensing and collaboration agreement to develop proprietary cancer immuno-oncology products
- Read more about Aegerion Pharma get Japanese approval for Juxtapid
Aegerion Pharmaceuticals, Inc. announced that Japan's Ministry of Health, Labor & Welfare (MHLW) has approved Juxtapid for patients with homozygous familial hypercholesterolemia (HoFH).

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- Read more about Daiichi Sankyo Initiates Phase 3 study of CS-3150 for Treatment of Essential Hypertension
Daiichi Sankyo Company, Limited announced that it has initiated a Phase 3 pivotal study of CS-3150 (esaxerenone (r-INN)), its non-steroidal, selective novel mineralocorticoid receptor (MR) antagonist, for patients in Japan with essential hypertension.
- Read more about Daiichi Sankyo to present phase 1 data evaluating DS-8201a at ESMO 2016 congress
Daiichi Sankyo Company, Limited announced that safety and preliminary efficacy phase 1 data evaluating DS-8201a, a novel HER2-targeting antibody drug conjugate, will be presented during a late-breaking poster discussion session during the European Society for Medical Oncology (ESMO) 2016 Congress from October 7 -11 in Copenhagen, Denmark.
- Read more about Medtronic Receives FDA Approval for World's First Hybrid Closed Loop System
Medtronic plc announced it has received U.S. Food and Drug Administration (FDA) approval of its MiniMed® 670G system - the first Hybrid Closed Loop insulin delivery system approved anywhere in the world. Featuring the company's most advanced algorithm - SmartGuard(TM) HCL - the system is the latest innovation in Medtronic's phased approach toward developing a fully automated, closed loop system.
- Read more about Medtronic's StealthStation® Cranial Software Receives FDA Clearance
Medtronic plc announced U.S. Food and Drug Administration (FDA) clearance of StealthStation® Cranial Software as an aid for deep brain stimulation (DBS) lead placement. The software is fully integrated with Medtronic's latest O-arm® Imaging System, providing clinicians with a complete procedural solution for the planning and placement of DBS leads. The announcement was made at the Congress of Neurological Surgeons (CNS) in San Diego.
- Read more about U.S. FDA grant Orphan Drug Designation to Soricimed’s SOR-C13
Soricimed Biopharma Inc. announce that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to peptide SOR-C13 for the treatment of pancreatic cancer. This follows the same designation for ovarian cancer.

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- Read more about Amgen present Top-Line Results From Phase 3 KYPROLIS® CLARION Study
Amgen announced top-line results of the Phase 3 CLARION trial, which evaluated an investigational regimen of KYPROLIS® (carfilzomib), melphalan and prednisone (KMP) versus Velcade® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 percent CI, 0.75 - 1.10). While the data for overall survival, a secondary endpoint, are not yet mature, the observed hazard ratio (KMP versus VMP) was 1.21 (95 percent CI, 0.90 - 1.64). Neither result was statistically significant.
- Read more about Amgen And UCB declare U.S. FDA Accept BLA Application For Romosozumab
Amgen and UCB announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
- Read more about U.S. FDA give clearance to BrainScope’s advanced medical device for assessing TBI
BrainScope Company, Inc. announced that the United States Food and Drug Administration (FDA) has cleared the company to market the Ahead 300, its most advanced medical device for use in assessing traumatic brain injury (TBI). Developed in partnership with the U.S. Department of Defense, the Ahead 300 provides a multi-modal device of clinically relevant measures, offering clinicians a comprehensive panel of data to assist in their diagnosis of the full spectrum of TBI, including concussion. The Ahead 300 represents an evolution from the three BrainScope products that have previously received FDA clearance, and with its substantial additional capabilities, will be the first product the company will sell commercially.