相关临床试验
4
1 进行中
药物批准
158
批准总数
监管机构
1
监管机构数
成立时间
N/A
已完成
3
75.0%
尚未招募
1
25.0%
- Septerna, Inc. has appointed Rajiv Patni, M.D., as Chief Medical Officer to lead its clinical development strategy for GPCR-targeting oral medicines. - Dr. Patni brings more than 25 years of experience and has contributed to 10 regulatory agency approvals or label expansions across the United States, Europe, and additional markets. - He joins Septerna from Judo Bio, where he served as Chief Executive Officer, and previously held CMO roles at Global Blood Therapeutics, Portola Pharmaceuticals, Adamas Pharmaceuticals, and Actelion Pharmaceuticals. - CEO Jeffrey Finer, M.D., Ph.D., stated that Dr. Patni's leadership will be instrumental as the company advances its clinical programs across endocrinology, immunology, and other therapeutic areas.
- A new clinical trial in Kenya is evaluating Roche's GDC-6036, a novel drug targeting the KRAS gene, in cancer patients. - The trial aims to determine if GDC-6036 can effectively block the mutation of the KRAS gene into the KRAS G12C variant, which is implicated in various cancers. - The study emphasizes the importance of conducting clinical trials in Africa to develop therapies that are better suited to the genetic specifications of African populations. - The trial seeks to provide new treatment options for cancer patients and contribute to the advancement of precision oncology in the region.
- The International Council for Harmonisation (ICH) has released draft E6(R3) guidelines aimed at modernizing Good Clinical Practice standards, with final implementation expected in 2025. - The new guidelines introduce a risk-proportionate approach to clinical trial management, replacing rigid Quality Tolerance Limits with more flexible 'Acceptable Ranges' to enhance trial efficiency. - E6(R3) addresses the challenges of managing increasing data volumes in clinical trials, with studies now handling up to 6 million data points and multiple data sources.
