The Cleveland Clinic Foundation
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Subsidiary, Private
- Established
- 1921-01-01
- Employees
- 1K
- Market Cap
- -
FDA Advisory Committee Votes 6-2 in Favor of Daratumumab for High-Risk Smoldering Multiple Myeloma
• The FDA's Oncologic Drug Advisory Committee (ODAC) voted 6-2 that daratumumab (Darzalex Faspro) demonstrates a favorable benefit-risk profile for patients with high-risk smoldering multiple myeloma, potentially offering the first approved therapy for this precursor condition.
• The phase 3 AQUILA trial showed daratumumab significantly delayed progression to active multiple myeloma with a 51% reduction in risk of progression or death compared to active monitoring, with 5-year PFS rates of 63.1% versus 40.8%.
• Committee members expressed concerns about risk classification accuracy and potential overtreatment, but ultimately determined the benefits outweighed risks for this malignant condition that has an 80% five-year progression risk to symptomatic multiple myeloma.
Surgical Robotics Advance: EndoQuest and Virtuoso Begin First Human Trials for Minimally Invasive Procedures
• EndoQuest Robotics has initiated its pivotal Paradigm trial for an endoluminal robotic system designed to perform endoscopic submucosal dissection for colorectal lesions through natural body openings.
• Virtuoso Surgical has successfully completed first-in-human procedures using its robotic endoscopy system with needle-sized manipulators to perform en bloc bladder tumor resections at The Chinese University of Hong Kong.
• Both robotic systems aim to address technical challenges in minimally invasive procedures, potentially reducing the need for more invasive surgeries and improving patient outcomes.
SeaStar Medical Reaches Halfway Enrollment Milestone in Pivotal NEUTRALIZE-AKI Trial for Acute Kidney Injury
• SeaStar Medical has reached the halfway point in its NEUTRALIZE-AKI pivotal trial, enrolling 100 of the planned 200 adult patients with acute kidney injury requiring continuous renal replacement therapy.
• The trial is evaluating the company's Selective Cytopheretic Device (SCD) therapy, which has received FDA Breakthrough Device Designation for treating AKI, a condition affecting over 200,000 adults annually in the U.S.
• An independent Data Safety Monitoring Review Board will conduct a prespecified interim analysis of the trial's primary endpoint, with findings expected in Q3 2025.
36-Month Results of OpRegen Cell Therapy for Geographic Atrophy to Be Presented at CTS 2025
• Long-term 36-month data from the Phase 1/2a trial of RG6501 (OpRegen) for geographic atrophy secondary to AMD will be presented at Clinical Trials at the Summit in June 2025.
• OpRegen, an allogeneic retinal pigment epithelial cell therapy developed by Lineage Cell Therapeutics in collaboration with Roche and Genentech, aims to counteract RPE cell loss in geographic atrophy.
• The therapy is currently advancing in a separate Phase 2a clinical study, potentially offering a novel treatment approach for geographic atrophy, a leading cause of adult blindness affecting over 5 million people globally.
Weight Loss Injections Show Promising Anti-Cancer Effects Beyond Weight Reduction
• Research presented at the European Congress on Obesity suggests weight loss injections may reduce obesity-related cancer risk by nearly 50%, potentially through anti-inflammatory mechanisms beyond simple weight reduction.
• Scientists from the University of Manchester are designing a large-scale clinical trial involving tens of thousands of patients to further investigate GLP-1 agonists as cancer prevention tools.
• Experts believe these findings could herald a "new dawn" in preventative cancer medicine, potentially benefiting even non-obese individuals with high cancer risk factors.
Trailhead Biosystems Secures $20M to Advance iPSC Technology for Drug Discovery and Regenerative Medicine
• Trailhead Biosystems has raised $20 million in funding led by MAK Capital to enhance its portfolio of induced pluripotent stem cell (iPSC) derived cells for research applications.
• The company's proprietary High-Dimensional Design of Experiments (HD-DoE®) platform enables precise differentiation of iPSCs into functional human cell types, supporting drug discovery and disease modeling.
• Trailhead recently launched TrailBio® Vascular Leptomeningeal Cells for blood-brain barrier research and plans to introduce iPSC-derived pancreatic islets, hepatocytes, dopaminergic neurons, and hematopoietic progenitors.
FDA Issues Urgent Warning Against "Gas Station Heroin" Tianeptine, Citing Severe Health Risks
• The FDA has issued a strong warning against tianeptine, commonly known as "gas station heroin," stating it poses a "dangerous and growing health trend" particularly threatening to young Americans.
• Tianeptine, which has not received FDA approval for any medical use in the US, is readily available at gas stations, convenience stores, and online despite being banned in ten states including Ohio, Alabama, and Florida.
• Daily use of tianeptine can cause severe adverse effects including agitation, respiratory depression, addiction with opioid-like withdrawal symptoms, and potentially death, with FDA Commissioner Dr. Marty Makary urging immediate public awareness.
EMA Suspends Valneva's IXCHIQ Chikungunya Vaccine for Elderly Following Safety Concerns
• European Medicines Agency has suspended the use of Valneva's IXCHIQ chikungunya vaccine in people over 65 years old following reports of 17 serious adverse events, including two deaths, in elderly patients.
• The suspension is temporary while authorities review safety data, with EMA maintaining current recommendations for IXCHIQ use in people aged 12 to 64 years, affecting over 40,000 doses administered worldwide.
• Similar precautionary measures were previously implemented in the United States and France, with Valneva's Chief Medical Officer pledging full cooperation with health authorities while exploring potential updates to the product's indication.
Women with Autoimmune Diseases Face 50% Higher Risk of Heart-Related Death Than Men
• Women with rheumatoid arthritis, lupus, or systemic sclerosis have a 50% higher cardiovascular mortality rate than men, according to a new Cleveland Clinic study published in Circulation.
• Researchers analyzed over 127,000 heart disease-related deaths among autoimmune patients, finding that stroke and clogged arteries were the primary causes, with women dying at higher rates than men from both conditions.
• Despite an overall decline in cardiovascular deaths among autoimmune patients between 1999-2020, women remain disproportionately affected, highlighting the need for early and regular cardiovascular risk screening in this population.
Early Combination of Statins and Ezetimibe Could Prevent Thousands of Heart Attacks, Study Finds
• Researchers from Imperial College London and Lund University found that early combination therapy with statins and ezetimibe significantly reduces the risk of subsequent heart attacks and death in cardiac patients.
• The study analyzed data from 36,000 heart attack patients, revealing that those receiving combination treatment within 12 weeks had better outcomes than patients receiving delayed treatment or statins alone.
• Implementation of early combination therapy could prevent an estimated 133 heart attacks per 10,000 patients over three years, potentially saving 5,000 heart attacks in the UK over a decade.
Study Reveals Factors Influencing Immune Checkpoint Inhibitor Efficacy in Metastatic Colorectal Cancer
• Cleveland Clinic and Moffitt Cancer Center researchers analyzed data from nearly 19,000 metastatic colorectal cancer patients, confirming immune checkpoint inhibitors significantly improve survival in MSI-H tumors compared to chemotherapy alone.
• The study identified specific factors that may enhance immune checkpoint inhibitor efficacy in traditionally unresponsive MSS tumors, including high albumin levels and recent antibiotic use, potentially expanding treatment options.
• Approximately 12.3% of patients with MSS tumors achieved durable responses to immune checkpoint inhibitors, suggesting the need for further research to identify biomarkers that could predict treatment success in this population.
Anixa Biosciences to Present Novel Ovarian Cancer CAR-T Therapy Data at ASCO 2025
• Anixa Biosciences will present Phase 1 clinical trial data on its innovative ovarian cancer CAR-T therapy at the 2025 ASCO Annual Meeting in Chicago, featuring a unique chimeric endocrine receptor-T cell technology.
• The company's novel approach targets the follicle-stimulating hormone receptor (FSHR) on ovarian cancer cells, differentiating it from traditional CAR-T therapies by utilizing the natural ligand FSH rather than antibody fragments.
• Dr. Robert Wenham from Moffitt Cancer Center, the principal investigator, will lead the presentation, highlighting Anixa's strategic collaborations with premier research institutions to advance next-generation immunotherapies for solid tumors.
FDA Removes Ozempic and Wegovy from Shortage List, Sparking Legal Challenge from Compounding Groups
• The FDA has officially removed Novo Nordisk's semaglutide products, Ozempic and Wegovy, from its drug shortage list after being listed since 2022, signaling improved supply availability.
• Compounding groups have filed a lawsuit challenging the FDA's decision, arguing it was made without proper stakeholder consultation and despite ongoing supply challenges acknowledged by Novo Nordisk.
• The legal dispute highlights broader tensions between pharmaceutical manufacturers and compounding facilities over access to semaglutide for treating type 2 diabetes, obesity, and cardiovascular disease.
Anti-IL23p19 Therapies Transform IBD Treatment Landscape Ahead of ECCO 2025
• The anti-IL23p19 class has emerged as a breakthrough in IBD treatment, with three major players - AbbVie's Skyrizi, Eli Lilly's Omvoh, and J&J's Tremfya - reshaping the therapeutic landscape.
• ECCO 2025 will showcase critical data for these therapies, including Omvoh's long-term efficacy in Crohn's disease, Tremfya's subcutaneous induction results, and new bowel urgency endpoints for ulcerative colitis.
• Market dynamics are evolving with the entry of Stelara biosimilars in Europe and the emergence of new therapeutic approaches, including TL1A inhibitors and IL-7R antagonists.
FDA Grants Priority Review to Astellas' Zolbetuximab for Gastric and GEJ Adenocarcinoma
• The FDA has granted Priority Review to Astellas' Biologics License Application (BLA) for zolbetuximab, a Claudin 18.2-targeted monoclonal antibody.
• Zolbetuximab is intended as a first-line treatment for locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
• The BLA is supported by positive results from the Phase 3 SPOTLIGHT and GLOW trials, evaluating zolbetuximab in combination with chemotherapy regimens.
• The FDA's target action date is set for January 12, 2024, potentially making zolbetuximab the first Claudin 18.2-targeted therapy available in the US.
Tolebrutinib Receives FDA Breakthrough Therapy Designation for Non-Relapsing Secondary Progressive Multiple Sclerosis
• The FDA has granted Breakthrough Therapy designation to tolebrutinib for adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS).
• The designation is based on positive results from the HERCULES phase 3 study, which demonstrated a 31% delay in disability progression compared to placebo.
• Tolebrutinib is the first brain-penetrant BTK inhibitor to receive this designation for MS, addressing a critical unmet need in delaying disability progression.
• Regulatory submissions for tolebrutinib are being finalized in the US and EU, with ongoing studies for primary progressive MS anticipated in H2 2025.
Semaglutide Shows Promise in Reducing Alcohol Consumption and Cravings
• A new study reveals that semaglutide, known as Ozempic and Wegovy, significantly reduces alcohol cravings and consumption in individuals with alcohol use disorder.
• Participants on semaglutide experienced fewer heavy drinking days and decreased alcohol intake during lab tests compared to those on a placebo, indicating potential therapeutic benefits.
• The research suggests semaglutide's effects on alcohol cravings may surpass existing treatments, offering a promising avenue for addressing the unmet needs in alcohol use disorder.
• Further studies are warranted to explore semaglutide's long-term efficacy, optimal dosages, and safety, particularly for individuals without obesity or diabetes.
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