Clinical Trial News
Navigating Latin American Pharma Markets: Challenges and Opportunities Amid Regulatory Evolution
• Latin American pharmaceutical markets face significant barriers including bureaucratic complexities, political instability, and currency devaluation, leading some companies to exit the region entirely.
• COVID-19 has exposed healthcare system vulnerabilities in Latin America, disrupting supply chains and highlighting the need for innovative solutions like telemedicine, particularly in underserved areas.
• Regional governments are increasingly adopting sophisticated regulatory frameworks modeled after European standards, though strict price controls continue to impact medicine accessibility and market dynamics.
mRNA Vaccines: How Moderna and Pfizer-BioNTech Revolutionized COVID-19 Immunization
• Moderna and Pfizer-BioNTech developed mRNA-based COVID-19 vaccines with efficacy rates exceeding 90%, representing a breakthrough in vaccine technology during the pandemic.
• Both vaccines use lipid nanoparticle technology to deliver mRNA instructions that teach cells to produce the coronavirus spike protein, triggering a protective immune response without causing infection.
• The vaccines require different storage conditions, with Pfizer's needing ultra-cold temperatures of -94°F (-70°C) while Moderna's remains stable at -4°F (-20°C), affecting global distribution logistics.
COVID-19 Trial Reporting Lags, Hampering Research Efficiency
• A systematic review reveals that the majority of registered COVID-19 trials have not reported results, hindering research progress.
• Most published trials focus on hospitalized patients, leaving gaps in outpatient and preventative treatment evidence.
• Data sharing among COVID-19 trials is limited, impeding collaboration and real-time guidance for healthcare professionals.
• Many trials face recruitment challenges, raising concerns about statistical power and the validity of study findings.
Highlighted Clinical Trials:
Erasmus Medical Center
Posted 4/8/2020
FDA Grants Fast Track Designation to Remestemcel-L for COVID-19 ARDS Treatment
• The FDA has granted Fast Track designation to remestemcel-L for treating acute respiratory distress syndrome (ARDS) due to COVID-19, addressing a critical unmet need.
• Clinical data from a pilot study showed that 75% of ventilator-dependent COVID-19 ARDS patients were successfully discharged after remestemcel-L treatment.
• A Phase 3 trial is ongoing, evaluating remestemcel-L in up to 300 ventilator-dependent patients with moderate to severe COVID-19 ARDS, with mortality as the primary endpoint.
• Mesoblast has partnered with Novartis for the development, manufacturing, and commercialization of remestemcel-L, initially focusing on ARDS treatment.
Colchicine, a Gout Drug, Enters RECOVERY Trial as Potential COVID-19 Treatment
• Colchicine, an anti-inflammatory drug used for gout, is being evaluated in the RECOVERY trial for its potential to treat hospitalized COVID-19 patients.
• The RECOVERY trial, the world's largest clinical trial for COVID-19 treatments, will assess colchicine's ability to reduce the risk of death after 28 days in approximately 5,000 patients.
• Colchicine's anti-inflammatory properties may help combat the excessive immune response seen in severe COVID-19, potentially preventing lung damage and reducing the need for ventilation.
• The RECOVERY trial has already identified dexamethasone as effective in reducing mortality in severe COVID-19 cases and has ruled out other treatments like hydroxychloroquine.
Technological Advances and Patient Partnerships Drive New Era in Rare Disease Drug Development
• Changing economics and technological innovations, including machine learning, are transforming rare disease drug development from an economic no-go area to a viable pharmaceutical investment.
• Patient group partnerships and early engagement in drug development are proving crucial for trial success and cost reduction, with companies like Pfizer and Healx leading collaborative approaches.
• The rare disease landscape shows promising developments with over 7,000 identified conditions, driven by regulatory flexibility and increased patient advocacy involvement in research direction.
Significant Improvement in Progression-Free Survival with SARCLISA Combination Therapy for Previously Treated Multiple Myeloma
A Phase 3 trial reveals that patients with previously treated multiple myeloma who stopped responding to Revlimid experienced a median progression-free survival of 41.7 months with SARCLISA combined with Kyprolis and dexamethasone, compared to 20.8 months with Kyprolis and dexamethasone alone.
Gilead's $27 Billion Oncology Transformation: Strategic Deals Reshape Company's Future
• Gilead Sciences has executed over $27 billion worth of strategic oncology deals in 2020, marking its most aggressive push yet to establish leadership in cancer treatment.
• Under new leadership, including CEO Daniel O'Day and CFO Andrew Dickinson, Gilead has acquired Immunomedics for $21 billion and made significant investments in multiple biotech companies focused on immuno-oncology.
• The company aims to balance its traditional antiviral portfolio with a strong oncology presence, highlighted by the acquisition of Trodelvy, while maintaining approximately $11 billion for future strategic investments.
Integrated CBTI and PAP Adherence Program Improves Sleep and PAP Use in Veterans with Comorbid Insomnia and OSA
A randomized controlled trial demonstrated that a structured, manual-based intervention combining cognitive behavioral therapy for insomnia (CBTI) with a positive airway pressure (PAP) adherence program significantly improved sleep outcomes and PAP use among middle-aged and older veterans with comorbid insomnia and obstructive sleep apnea (OSA). The intervention, delivered by a sleep coach with weekly supervision by a behavioral sleep medicine specialist, showed sustained improvements at 3 and 6 months follow-up.
Havas Health & You Launches Global Research Initiative to Track Healthcare Evolution Post-COVID
• Havas Health & You has initiated 'Behind the Mask', a comprehensive longitudinal study combining qualitative and quantitative research to document healthcare delivery changes during and after COVID-19.
• The research reveals significant concerns among healthcare providers, with 79% of clinicians anticipating a COVID-19 resurgence, up from 70% in earlier surveys.
• The project aims to build stronger health brands by capturing authentic healthcare provider experiences through auto-ethnography, including real-time documentation from doctors after lengthy shifts.