The new operations provide Kendle’ customers (mainly global biopharmaceutical players) access to additional patient populations while strengthening the company’s position as a global clinical development partner. Candace Kendle,
Rigel Pharmaceuticals has announced that its oral Syk inhibitor, R788, is being evaluated in a Phase 2 clinical trial funded, designed and implemented by the National Cancer Institute
The study, which is intended to be used to support a regulatory filing in the US, includes more than 900 patients aged 51 to 80 with a medical
Among other things, the complete response letter includes certain assigned works for the company. FDA has said that the company need to conduct an additional clinical efficacy trial
A registered IRB can extend its federalwide assurance to a trial site, but the assurance doesn’t prove compliance, OHRP director Jerry Menikoff said. OHRP provides leadership in the
These results were obtained from subset analysis of the Phase 3 evaluation of Natalizumab as Continuous Therapy (ENACT-2) and efficacy of Natalizumab in Crohn’s Disease Response and Remission
BSI-201 is a novel investigational agent that acts by inhibiting PARP1, an enzyme that repairs DNA damage. In this study, 116 women with metastatic TNBC, defined by tumors
Interim results from the ongoing Phase II dose-escalation study were presented at the 2009 Annual Meeting of American Society of Clinical Oncology. Cynthia Sullivan, President and CEO, said:
The North America-based, randomized, multi-center, double-blind, placebo-controlled, dose-range-finding, parallel group phase II(b) study was designed to assess the safety, efficacy, and dose response of linaclotide in patients with
The study conducted on 515 patients showed a significant increase in progression-free survival at three years for patients treated with the gemcitabine chemoradiation combination versus those treated only
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