Devyser’s hereditary breast and ovarian cancer (HBOC) test has received a CE mark from the European Commission and is now approved as a diagnostic test for both cancers in Europe. The CE mark is a certification for products sold in the European Economic Area to indicate the product has met all legal standards, and has been evaluated to meet…
ProFound AI Risk, a diagnostic tool that estimates the risk of breast cancer over a two-year period following a mammogram, has received a CE mark from the European Commission. The CE mark is a certification for products sold in the European Economic Area to indicate the product has met all legal standards, and has been evaluated to…
Immunomedics has announced that its Phase 3 ASCENT trial of Trodelvy (sacituzumab govitecan) met its main goal of demonstrating that the medication is superior to standard chemotherapy at delaying disease progression and prolonging the survival of people with metastatic triple-negative breast cancer (mTNBC). The biopharmaceutical company had closed ASCENT (NCT02574455) early, in April, due to…
A diet high in total fiber appears to lower the risk of breast cancer for both pre- and postmenopausal women, researchers who pooled data from 20 observational studies reported. This association was found valid for different sources of fiber — foods like cereals, fruits, vegetables, and legumes that make up total fiber. But links between diet and…
Testing of a second and higher dose of ACI-35.030, a potential Alzheimer’s vaccine, is now beginning in a Phase 1b/2a clinical trial, AC Immune announced. Positive interim safety, tolerability, and specificity results from an initial dosing group of patients allowed the trial to advance to its medium dosing regimen, the company reported in a press release. ACI-35.030, being developed…
Vaccines against the flu and pneumonia are associated with a lower risk of developing Alzheimer’s disease, while infections are generally linked to increased mortality among people with dementia, according to three research studies presented at this year’s Alzheimer’s Association International Conference, which is being held virtually this week. “With the COVID-19 pandemic, vaccines are at…
The U.S. Food and Drug Administration (FDA) has accepted a request by Acadia Pharmaceuticals‘ that Nuplazid (pimavanserin) be approved for a new indication: the treatment of delusions and hallucinations associated with dementia-related psychosis. The company’s supplemental new drug application, which was submitted in June, was granted standard review status. The FDA’s decision is expected by April…
BAN2401, an experimental treatment for Alzheimer’s disease (AD), will be tested in the new global AHEAD 3-45 clinical trial, its developers have announced. The Phase 3 study — to be conducted in the U.S., Canada, Japan, Australia, Singapore, and Europe — will test the therapy in people who are in the early stage of the…
The Alzheimer’s Foundation of America (AFA) is expanding the availability of its National Toll-Free Helpline — adding weekend hours as well as chat and message features in dozens of languages — to provide greater support to patients and family members. The resource’s hours now are 9 a.m. to 9 p.m. EST on weekdays, and 9…
The U.S. Food and Drug Administration (FDA) has approved Bavencio (avelumab) as a first-line maintenance therapy for people with advanced urothelial carcinoma — a type of bladder cancer — whose disease did not worsen while receiving platinum-based chemotherapy. The decision was based on data from the ongoing JAVELIN Bladder 100 Phase 3 trial (NCT02603432). That data…
