InterVenn Biosciences has raised $34 million to commercialize a new diagnostic tool for ovarian cancer, based on the identification of circulating proteins containing sugar molecules (glycoproteins). The company expects to validate the diagnostic tool intended for immediate clinical use and drive rapidly expanding partnership projects. The funding will also help accelerate the use of glycoproteins in…
ARX788 has been given a fast track designation by the U.S. Food and Drug Administration as a monotherapy for patients with HER2-positive metastatic breast cancer previously treated with at least one anti-HER2-based regimen. The designation helps to accelerate the clinical development and expedite the approval of promising therapies for serious diseases, by providing more frequent…
The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough therapy to a combination of tiragolumab, a novel immunotherapy developed by Genentech, plus Tecentriq (atezolizumab) for the treatment of metastatic non-small cell lung cancer (NSCLC). The designation is intended to accelerate the development and review of medications that may be superior to…
The Alzheimer’s Association and its advocacy affiliate, the Alzheimer’s Impact Movement (AIM), are lauding recent actions by lawmakers that will fund and advance multiple Alzheimer’s disease policies. The advancements are part of the $1.4 trillion government funding bill for the 2021 fiscal year that was passed by Congress on Dec. 21 and later signed into law by President Trump. The appropriations…
Long-term exposure to androgen deprivation therapy (ADT), a common treatment for prostate cancer, is associated with worse cardiorespiratory fitness and a higher risk of cardiovascular death, a new study reports. Men who received ADT therapy for more than six months were ultimately found to have a nearly four times higher risk of death than those…
Rubraca (rucaparib) is superior to chemotherapy at prolonging life without disease worsening in people with advanced ovarian cancer who received at least two prior lines of chemotherapy, according to top-line data from an ongoing Phase 3 trial. Data from the study, called ARIEL4 (NCT02855944), also showed that Rubraca’s safety profile in these women, whose tumors contained…
The U.S. Food and Drug Administration (FDA) has approved a triple combination of Xpovio (selinexor) plus Velcade (bortezomib) and low-dose dexamethasone for the treatment of people with multiple myeloma who received at least one line of therapy. The approval, which comes three months ahead of deadline, was based on promising data from the BOSTON Phase…
Combining two experimental cancer vaccines with Libtayo (cemiplimab) promotes strong anti-tumor immune responses and shows early signs of effectiveness in adults newly diagnosed with glioblastoma — the most aggressive type of brain cancer — according to interim data from a Phase 1/2 trial. Developed by Inovio Pharmaceuticals, the DNA-based vaccines, called INO-5401 and INO-9012, are…
The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended the conditional approval of trastuzumab deruxtecan (DS-8201) for the treatment of patients with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens. The therapy, which has received accelerated assessment in Europe, already has been approved in Japan…
Novo Nordisk is planning to initiate by midyear a pivotal Phase 3a trial of oral semaglutide, a diabetes treatment, in people with early Alzheimer’s disease. “As a company we aspire to address high unmet medical needs within serious chronic diseases, and we are therefore pleased to initiate phase 3 development of semaglutide within Alzheimer’s disease,” Mads…
