The U.S. Food and Drug Administration (FDA) has approved FoundationOne Liquid CDx to be used as a companion diagnostic test to identify men with metastatic castration-resistant prostate cancer (mCRPC) who are likely to benefit from treatment with Lynparza (olaparib). Developed by Foundation Medicine, the test is a blood-based biopsy assessment approved by the FDA to…
The European Commission has approved Opdivo (nivolumab) as a second-line treatment for adults with advanced inoperable, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), who previously were treated with fluoropyrimidine and platinum chemotherapy agents. This decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency. With…
The U.S. Food and Drug Administration (FDA) has designated 4D Path’s software a breakthrough device as a possible way to achieve a faster and more accurate breast cancer diagnosis based on tissue taken in a breast biopsy or resection. Named 4D Q-plasia OncoReader Breast, the software is intended to aid doctors in evaluating biopsies and resections (tumors that are surgically…
A Phase 1 trial is enrolling patients with mild to severe dementia from Alzheimer’s disease to test IGC-AD1, an investigational cannabis-based treatment being developed India Globalization Capital (IGC) Pharma, a subsidiary of IGC, according to a recent press release. In the placebo-controlled study, 12 participants will receive the medication over three 14-day periods, with the…
Xgeva (denosumab) has been approved by the China National Medical Products Administration (NMPA) to prevent bone problems — such as fractures, spinal cord compressions, and the need for radiation or surgery — in people with multiple myeloma and in those with bone metastases from solid tumors. Xgeva was previously approved in China to treat adults, and adolescents…
Merck has decided to suspend its Phase 3 trial that was assessing a combination of Yervoy (ipilimumab) and Keytruda (pembrolizumab) as a first-line therapy for patients with advanced non-small cell lung cancer (NSCLC), the company announced in a press release. The decision to halt the study was based on recommendations from an independent data monitoring committee,…
AlzeCure Pharma is preparing to launch a Phase 1 clinical trial in Sweden to evaluate the tolerability and safety of ACD856, one of its therapy candidates for Alzheimer’s disease, the company announced. The trial follows the release of the first positive clinical results, in which ACD856 showed a good pharmacokinetic profile (how the body affects…
The Prostate Cancer Foundation (PCF) has committed $5 million to support the launch of two new Centers of Excellence that will provide precision medicine treatments to veterans with prostate cancer. The centers are being launched in collaboration with the Veterans Administration Boston Healthcare System, the Dana-Farber Cancer Institute, the VA Portland Health Care System, and…
The combination of Keytruda (pembrolizumab) and ALKS 4230 was able to halt disease progression and reduce tumor size in a small group of heavily pre-treated patients with advanced ovarian cancer, according to data from an ongoing Phase 1/2 trial. Findings from the trial, called ARTISTRY-1 (NCT02799095), also showed the combination therapy had a manageable safety…
A new $100-million program aims to improve the diversity of participants in U.S. clinical trials with the ultimate goal of achieving better health outcomes and parity in care for underserved patient populations. The initiative seeks to extend the reach of clinical studies to underserved populations in the nation’s urban and rural communities, and promote treatment development…
