Clinical Trial News
India's Corbevax COVID-19 Vaccine Upgraded from Emergency Use to Full Drug Approval for Ages 5 and Above
- India's Subject Expert Committee has recommended upgrading Biological E's Corbevax COVID-19 vaccine from emergency use authorization to full drug approval for individuals aged 5 years and above after reviewing extensive safety and efficacy data.
- The indigenous RBD protein sub-unit vaccine has demonstrated persistent humoral response with binding antibody titers against the RBD protein and neutralizing antibody titers against SARS-CoV-2 for up to one year post-vaccination.
- With over 85 million doses administered globally and WHO Emergency Use Listing achieved in January 2024, Corbevax has shown no additional safety concerns throughout its widespread implementation in vaccination programs.
Medicare Low-Income Drug Subsidy Loss Linked to Higher Mortality Rates
- Loss of Medicare's Low-Income Subsidy (LIS) for prescription drugs following Medicaid disenrollment is associated with a 4% increase in mortality rates, according to a new study published in the New England Journal of Medicine.
- The mortality risk is significantly higher among vulnerable populations, with HIV patients experiencing a 22% higher death rate after losing coverage, and those with cardiovascular or chronic lung conditions also facing elevated risks.
- Researchers found that over half of beneficiaries who lost Medicaid eligibility regained it within a year, suggesting many were disenrolled due to administrative errors rather than actual ineligibility.
Weight Gain Combined with Delayed Motherhood Nearly Triples Breast Cancer Risk, Study Finds
- New research reveals women who gain significant weight after age 20 and delay childbirth until after 30 (or remain childless) face a 2.7 times higher risk of developing breast cancer.
- The study, presented at the European Congress on Obesity, is the first to establish how weight gain and age of first birth interact to affect breast cancer risk in women.
- Researchers analyzed data from nearly 48,500 women with an average age of 57, identifying over 1,700 breast cancer cases during the six-year follow-up period.
New Lung Allocation System Reduces Waitlist Deaths by 75% Since 2023 Implementation
- The United Network for Organ Sharing's Composite Allocation Score implemented in March 2023 has dramatically reduced lung transplant waitlist mortality from 11.2% to 4.1%.
- Patients are now three times less likely to die while waiting for lung transplants compared to the pre-2017 geographic proximity-based system.
- The sickest patients experienced the greatest benefit, with those in the top 5% medical urgency category seeing mortality drop from 34.5% to 6.5%.
- The new system prioritizes medical urgency alongside other health factors, representing a shift from geographic proximity to clinical need in organ allocation.
Dupilumab Reduces Asthma Exacerbations in Children Regardless of Disease Duration
- Children with uncontrolled moderate to severe asthma experienced significantly fewer exacerbations when treated with dupilumab compared to placebo, regardless of how long they had been living with the disease.
- The 52-week VOYAGE trial demonstrated that dupilumab improved asthma control in 6-11 year olds across all disease duration groups, with 62-79% of treated children achieving well-controlled status versus 35-56% on placebo.
- Researchers noted that while longer asthma duration was associated with more frequent exacerbations overall, dupilumab provided consistent clinical benefits that could help reduce the impact of persistent symptoms on developing lungs.
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Former President Biden Diagnosed with Metastatic Prostate Cancer
- Former President Joe Biden, 82, has been diagnosed with aggressive prostate cancer that has metastasized to his bones, with a Gleason score of 9 indicating high-grade disease.
- The cancer was discovered after Biden reported urinary symptoms, and while it represents an advanced stage with a 37% five-year survival rate for metastatic disease, it appears to be hormone-sensitive.
- Biden's medical team is reviewing treatment options including androgen deprivation therapy and androgen receptor-targeted therapy, which have significantly improved outcomes for metastatic prostate cancer in recent years.
- The diagnosis highlights the importance of symptom-based screening in older adults, as routine prostate cancer screening is typically discontinued at age 70.
FDA Clears Brainstorm Cell Therapeutics' Phase 3b Trial of NurOwn for ALS Treatment
- Brainstorm Cell Therapeutics has received FDA clearance to initiate a Phase 3b trial of NurOwn for the treatment of Amyotrophic Lateral Sclerosis (ALS), marking a significant advancement in their clinical development program.
- The company's proprietary NurOwn technology utilizes Mesenchymal Stem Cells (MSC) that are differentiated into neurotrophic factor-secreting cells and transplanted near damaged areas, offering a novel approach to treating neurodegenerative diseases.
- Following the FDA announcement, Brainstorm's stock surged by 31.82% in premarket trading, reflecting strong investor confidence in the potential of this stem cell therapy for ALS patients.
Post-Marketing Safety Analysis of Voclosporin Reveals New Adverse Event Patterns in Lupus Nephritis Treatment
- A comprehensive pharmacovigilance study analyzing FAERS data from 2021-2024 identified eight significant adverse event categories associated with voclosporin, including previously unreported gastrointestinal disorders.
- Nearly one-third of voclosporin-related adverse events occurred within the first month of treatment, with renal and infectious complications typically appearing later with a median onset time of 133 and 130.5 days respectively.
- Gender and age differences were observed in adverse event patterns, with females experiencing more headaches and gastrointestinal issues while males showed higher rates of renal function abnormalities and elevated uric acid levels.
UC Davis Scientists Develop Non-Hallucinogenic LSD Derivative That Shows Promise for Schizophrenia Treatment
- Researchers at UC Davis created JRT, a novel compound derived from LSD by repositioning just two atoms in its molecular structure, potentially offering a breakthrough treatment for schizophrenia without hallucinogenic effects.
- In preclinical studies, JRT demonstrated remarkable ability to regrow brain cells and repair neural pathways in mice, reducing negative schizophrenia symptoms like cognitive fog and social withdrawal.
- The compound also exhibited potent antidepressant properties, proving to be 100 times more effective than ketamine at a fraction of the dose, suggesting broad therapeutic potential for mental health conditions.
Interpace Biosciences Secures US Patent for MicroRNA Technology in Thyroid Cancer Diagnosis
- Interpace Biosciences has been granted a US patent for using microRNAs to differentiate between benign and malignant thyroid neoplasms, enhancing their diagnostic capabilities.
- The patented technology underpins ThyraMIR®, a microRNA classifier that works with ThyGeNEXT® to provide actionable results for indeterminate thyroid nodules, potentially reducing unnecessary surgeries.
- This intellectual property strengthens Interpace's position in personalized medicine, specifically in molecular diagnostics for improved thyroid cancer detection and patient management.