Clinical Research Focus. 23rd Edition
Cromos Pharma’s CEO Reflections on ESMO 2023: A Glimpse into the Future of Oncology
The European Society for Medical Oncology (ESMO) 2023 conference has left the global biotech and medical community abuzz with the latest groundbreaking developments in the field of oncology. This year’s conference showcased an array of promising reports and advancements that have captivated the attention of industry professionals and physicians.
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Revolutionizing Primary Care: A Real-World Analysis of AI-Enhanced Digital Stethoscope for Valvular Heart Disease Detection
This prospective study aimed to assess the real-world impact of a deep learning-based AI platform, integrated into a digital stethoscope, for detecting undiagnosed valvular heart disease (VHD) in primary care. Cardiac auscultation, the current standard, exhibits a 44% sensitivity in detecting VHD. The study enrolled 369 patients aged 50 and older without prior VHD diagnoses. The AI demonstrated a twofold improvement in sensitivity (94.1%) compared to primary care physician (PCP) auscultation (41.2%), with minimal impact on specificity (84.5% vs. 95.5%). The AI identified 22 previously undiagnosed patients with moderate-or-greater VHD, surpassing the eight cases identified by PCPs. These findings suggest that AI-powered auscultation in primary care may enhance early VHD detection, improving patient care and outcomes.
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The Power of Nutrition: How Healthier Diets Can Add Up to a Decade to Life Expectancy in the UK
In this study utilizing prospective population-based cohort data from the UK Biobank, researchers demonstrate the significant impact of sustained dietary changes on life expectancy. Transitioning from unhealthy dietary patterns to the recommended Eatwell Guide leads to a gain of 8.9 and 8.6 years in life expectancy for 40-year-old males and females, respectively. Moreover, adopting longevity-associated dietary patterns results in even more substantial gains, with an increase of 10.8 and 10.4 years in life expectancy for males and females. Notably, emphasizing the consumption of whole grains, nuts, and fruits, while reducing intake of sugar-sweetened beverages and processed meats, yields the most substantial benefits. This research highlights the potential of sustained dietary modifications to prevent non-communicable diseases and offers valuable insights for shaping health policies.
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Medical Milestone: FDA Greenlights First-Ever Treatment for Rare Non-Cancerous Tumors
The FDA has granted approval for Ogsiveo (nirogacestat) tablets, marking a significant breakthrough as the first therapy authorized for adults with progressing desmoid tumors—a rare subtype of non-cancerous soft tissue sarcomas requiring systemic treatment. Desmoid tumors, though non-cancerous, can exhibit local aggressiveness, leading to pain, restricted movement, and diminished quality of life by infiltrating nearby structures and organs.
The approval stems from a pivotal international trial involving 142 adult patients with desmoid tumors not suitable for surgery. In this randomized, double-blind, placebo-controlled study, participants received either 150 mg of Ogsiveo or a placebo orally twice daily until disease progression or intolerable side effects.
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Digital Era Commences: Selected Human Medicines Feature First-Ever Electronic Product Information (ePI)
The Heads of Medicines Agencies along with the European Commission and EMA, have jointly released electronic product information (ePI) for specific human medicines, marking the first harmonized effort across the EU. The product information encompasses the summary of product characteristics, labeling, and package leaflet for each medicine authorized in the EU. Traditionally available as PDF documents on EU regulators’ websites, and as printed leaflets within medicine packaging, the shift to electronic platforms introduces enhanced possibilities for real-time updates and improved accessibility. This move aims to facilitate easier access to vital information for healthcare professionals and patients alike.
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The FDA Gives Nod to the First Treatment for Patients Suffering from Rare Inherited Blood Clotting Disorder
The FDA has granted approval for Adzynma, the first recombinant (genetically engineered) protein product designed for prophylactic or on-demand enzyme replacement therapy (ERT) in both adult and pediatric patients diagnosed with congenital thrombotic thrombocytopenic purpura (cTTP)—a rare and life-threatening blood clotting disorder.
The efficacy of Adzynma was assessed through a study involving 46 patients who were randomly assigned to receive 6 months of either Adzynma or plasma-based therapies (Period 1), followed by crossing over to the alternative treatment for the subsequent 6 months (Period 2). The evaluation criteria included the incidence of thrombotic thrombocytopenic purpura (TTP) events, TTP manifestations, and the need for supplemental doses. This groundbreaking approval offers a promising therapeutic option for individuals with congenital TTP, addressing a critical unmet medical need.
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AbbVie Expands Oncology Portfolio with $10.1 Billion Acquisition of ImmunoGen and ELAHERE®, a Revolutionary Ovarian Cancer Therapy
AbbVie is set to acquire ImmunoGen, along with its flagship cancer therapy ELAHERE® (mirvetuximab soravtansine-gynx), a groundbreaking antibody-drug conjugate approved for platinum-resistant ovarian cancer. The $10.1 billion deal, expected to close in mid-2024, marks AbbVie’s strategic expansion into the ovarian cancer market and diversification of its oncology pipeline. ELAHERE, with FDA approval in 2022, targets folate receptor alpha (FRα) and presents a potential multi-billion-dollar opportunity. The acquisition includes ImmunoGen’s promising next-generation ADCs, aligning with AbbVie’s goal to ex[pand its oncology portfolio.
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