The US FDA on Wednesday approved Actavis’ Viberzi to treat IBS (irritable bowel syndrome) with diarrhea in adult men and women. The treatment will be manufactured by Ohio-based CMO Patheon.
The drug was approved after its safety and effectiveness were established in two double-blind, placebo-controlled clinical trials in which 2,425 patients were randomly assigned to receive Viberzi or placebo. Results showed Viberzi was more effective in simultaneously reducing abdominal pain and improving stool consistency than placebo over 26 weeks of treatment.
Quintiles in Asia-Pac
Quintiles launched a new solution set aimed at meeting the needs of emerging companies in Asia and the Pacific.
The new services come with dedicated local project leadership based in Asia-Pac with knowledge of local markets, customs and language; tailored operational models to meet individual customer priorities; and accelerated patient recruitment through its global network of clinical trial sites – with seven of its “Prime Sites” located in Asia-Pacific.
The new solution also gives emerging companies access to Quintiles’ data-driven insights; its knowledge of local markets; its in-depth therapeutic and scientific expertise; and its global drug development platform.
LabCorp has invested in ORIG3N, and will provide storage for induced pluripotent stem cells (iPSCs) at its biorepository facilities as well as perform genetic testing on the stored cells.
LabCorp's expertise aims to help accelerate the development of ORIG3N’s LifeCapsule's specimen repository, which is utilized to generate induced pluripotent stem cells. The repository will enable access to a large, genetically diverse population of iPSCs for biotechnology and pharmaceutical companies, supporting development of treatments for a variety of diseases. The strategic partnership between ORIG3N and LabCorp will increase the utility of LifeCapsule and establish a well characterized library of specimens.
CRO BioClinica has partnered with Kinapse to accelerate Risk-Based Monitoring (RBM) on global trials using its Compass Intelligent Monitoring solution. Kinapse offers strategy and operations consultancy and capability-building programs, including RBM, to life science companies, and works to ease the change management process as organizations transition to RBM.