Pharma News

FDA's Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally.

Alzheimer’s disease (AD) currently afflicts nearly seven million people in the U.S. With this number expected to grow to nearly 13 million by 2050, the lack of meaningful therapies represents a major unmet medical need. Scientists at Sanford Burnham Prebys have now identified promising real-world links between common HIV drugs and a reduced incidence of AD. The study, led by Jerold Chun, M.D., Ph.D., was published in Pharmaceuticals.

A recent breakthrough study from the lab of Tanya Kalin, MD, PhD, professor of Child Health and Internal Medicine at the University of Arizona College of Medicine – Phoenix, has shown potential to improve therapeutic outcomes for patients suffering from lung cancers.

“We have identified the novel protein FOXF1 that stabilizes blood vessels inside the lung tumors, decreases intertumoral hypoxia and prevents lung cancer metastases,” explained Dr. Kalin, the senior author on this study.

GSK plc announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The Prescription Drug User Fee Act (PDUFA) action date for a regulatory decision by the US FDA on this application is 14 February 2025.

Dr Javier Díez-Domingo, Principal Investigator, FISABIO (Foundation for the Promotion of Health and Biomedical Research of the Valencian Community, Spain) said: “These final data demonstrate continued protection over more than a decade with high efficacy maintained in both the 50+ and 70+ age groups.

Eli Lilly and Company announced positive topline results of the SURMOUNT-OSA phase 3 clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) compared to placebo, achieving the primary endpoints. Percentage change in AHI was a key secondary endpoint in both studies. AHI records the number of times a person's breathing shows a restricted or complete block of airflow per hour of sleep and is used to evaluate the severity of obstructive sleep apnea (OSA) and the effectiveness of treatment outcomes.

Human papillomavirus (HPV) is the second most common cancer-causing virus, accounting for 690,000 cervical and other cancers each year worldwide. While the immune system usually clears HPV infections, those that persist can lead to cancer, and a new finding suggests that certain women may have a genetic susceptibility for persistent or frequent HPV infections. These genetic variants, identified in a study led by University of Maryland School of Medicine researchers, could raise a woman’s risk of getting cervical cancer from a high-risk HPV infection.

A research team from the National University of Singapore (NUS) has unearthed new findings which may help explain the connection between cancer risk and poor diet, as well as common diseases like diabetes, which arise from poor diet. The insights gained from this study hold promise for advancing cancer prevention strategies aimed at promoting healthy ageing.

Using artificial intelligence (AI) to supplement radiologists’ evaluations of mammograms may improve breast-cancer screening by reducing false positives without missing cases of cancer, according to a study by researchers at Washington University School of Medicine in St. Louis and Whiterabbit.ai, a Silicon Valley-based technology startup.