As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how single-arm trials can be regulated, used to support the new drug application for cancer drugs, and accelerate oncology drug development.
As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how single-arm trials can be regulated, used to support the new drug application for cancer drugs, and accelerate oncology drug development.
A new cancer genomic test co-developed by Illumina Inc. and Merck & Co. Inc. will soon be available globally, excluding the U.S. and Japan. The research use only Trusight Oncology 500 HRD test is designed to identify genetic mutations used in the evaluation of homologous recombination deficiency (HRD), a signal that can indicate tumor formation. The product combines HRD technology from genetic test maker Myriad Genetics Inc. and next generation sequencing (NGS) technology from Illumina.
Despite a huge amount of progress in the hot space CD47, there’s a large space beyond it to explore, according to DEM Biopharma Inc.’s CEO David Donabedian. The new company just raised $70 million to develop therapies targeting don’t eat me, hence DEM, and eat me signals on cancer cells and macrophages.
A new large-scale study has found combining artificial intelligence (AI) and radiologists to analyze breast cancer screenings can lead to better patient outcomes, when compared with unaided radiologists and the use of AI alone. The study, published in The Lancet Digital Health, evaluated the performance of an AI decision referral system developed by Vara (MX Healthcare GmbH).
A presentation at the American Society of Clinical Oncology (ASCO) 2022 annual conference demonstrated that the Dxcover Cancer Liquid Biopsy differentiated between patients with cancer and healthy controls and detected more than 90% of stage I malignancies across a broad range of cancers. Dxcover Ltd. provided more details on its new approach to the search for reliable, rapid screening for multiple malignancies at the 12th International Conference on Clinical Spectroscopy on June 21.
Ibex Medical Analytics Ltd. extended the reach of its artificial intelligence (AI) powered pathology system, adding gastric cancer to existing CE mark approvals in prostate and breast cancer.
In May, Sidekick Health AB revealed an expanded partnership with New York-based Pfizer Inc. for autoimmune-related conditions. Now, it has joined forces with Eli Lilly and Co. to help patients battling breast cancer with its gamified platform. The companies plan to introduce the integrated digital therapeutic starting in July with the roll out beginning in Germany.
Singapore’s Agency for Science, Technology and Research (A*STAR) has inked a deal with Boehringer Ingelheim GmbH to develop and commercialize targeted cancer therapies.
