Clinical Trial News
FDA Rejects ImmunityBio's Expanded Anktiva Application While Lifting Hold on Atara's Ebvallo Trials
• ImmunityBio received an FDA "refusal to file" letter for its application to expand Anktiva's use in bladder cancer patients, causing a 25% stock plunge and prompting calls for agency clarification.
• The rejection comes despite Anktiva's approval last year for a related subset of bladder cancer patients, with ImmunityBio's founder Patrick Soon-Shiong citing "confounding inconsistency" in the FDA's decision-making process.
• In contrast, Atara Biotherapeutics received positive news as the FDA lifted its clinical hold on blood cancer drug Ebvallo and scheduled discussions for resubmission, driving a 6% stock increase.
€13.6M EU-Funded PREDI-LYNCH Project Aims to Transform Cancer Screening for Lynch Syndrome Patients
• The PREDI-LYNCH project has received €13.6 million in EU funding to develop non-invasive liquid biopsy tests for early cancer detection in Lynch Syndrome carriers, addressing a critical unmet medical need.
• Swedish diagnostics company Elypta joins 27 partners across 16 European countries in this six-year initiative (2025-2031), contributing its proprietary glycosaminoglycan-based biomarker technology.
• With only 5% of Europe's estimated 2 million Lynch Syndrome carriers under cancer surveillance, the project aims to create affordable, accessible screening methods for colorectal, endometrial, and urothelial cancers.
Azvudine Shows Comparable Effectiveness to Nirmatrelvir/Ritonavir for COVID-19 Patients with Chronic Liver Disease
• A multicenter retrospective study found that azvudine demonstrated effectiveness comparable to nirmatrelvir/ritonavir in reducing all-cause death and disease progression in COVID-19 patients with pre-existing chronic liver diseases.
• Azvudine showed superior effectiveness specifically for COVID-19 patients with comorbid primary malignant tumors, potentially offering an alternative treatment option for this vulnerable population.
• Both antiviral medications demonstrated acceptable safety profiles, with azvudine showing slightly better liver function outcomes in patients with chronic liver disease, providing important clinical guidance for treatment selection.
Highlighted Clinical Trials:
NCT06349655Completed
The First Affiliated Hospital of Zhengzhou University
Posted 12/5/2023
ImmuPharma Advances P140 Autoimmune Program with Novel Non-Immunosuppressive Mechanism
• ImmuPharma has made significant scientific breakthroughs with its P140 program, confirming a unique non-immunosuppressive mechanism of action for treating autoimmune conditions.
• The company plans to increase P140 dosage up to 20 times higher than previously tested, following FDA guidance and pharmacokinetic studies, potentially enhancing efficacy without steroid-like side effects.
• ImmuPharma is in active discussions with several global commercial partners while also advancing its anti-infective portfolio targeting fungal and bacterial infections.
New Teletrial Model Brings Hope to Severe Eczema Patients in Regional Areas
• A groundbreaking clinical trial at Alfred Health is offering new treatment options for severe eczema sufferers through an innovative teletrial model, allowing patients to receive care closer to home.
• The international study, also running in the US and Canada, is testing a novel treatment for moderate to severe eczema with Latrobe Regional Health becoming one of the first non-metropolitan hospitals worldwide to participate.
• After a year of treatment, the trial's first teletrial participant experienced significant improvement with reduced flare-ups and decreased reliance on steroid medications, demonstrating the potential impact of this accessible care model.
Sleep Disturbances in ICU Patients: New Research Reveals Impact on Recovery and Outcomes
• New research presented at ATS 2025 reveals that sleep patterns in ICU patients may serve as important biomarkers for predicting patient outcomes, with atypical N3 sleep linked to longer ICU stays.
• A study of ICU patients found that hypersomnia (sleeping more than 11 hours in 24 hours) was associated with higher mortality rates, longer hospital stays, and lower rates of discharge to home.
• Over 60% of ICU survivors with acute respiratory failure experience insomnia, with pre-existing mental health conditions and neurologic causes of respiratory failure significantly increasing this risk.
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.
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.